Rozerem Patient Information

Brand Names: Rozerem
Generic Name: ramelteon

Rozerem (ramelteon) full prescribing information

What is Rozerem?

Rozerem (ramelteon) is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Rozerem is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

Rozerem may also be used for other purposes not listed in this medication guide.

Important information about Rozerem

Do not use Rozerem if you are allergic to ramelteon, or if you have severe liver disease.

You should not take Rozerem if you are also taking the antidepressant fluvoxamine (Luvox).

Before taking Rozerem, tell your doctor if you have liver disease, sleep apnea, a breathing disorder such as chronic obstructive pulmonary disease, or a history of depression, mental illness, or suicidal thoughts.

Take this medicine 30 minutes before your normal bedtime. After you take Rozerem, avoid doing anything other than getting ready for bed.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Rozerem and talk with your doctor about another treatment for your sleep disorder.

What should I discuss with my healthcare provider before taking Rozerem?

Do not use Rozerem if you are allergic to ramelteon, or if you have severe liver disease.


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You should not take Rozerem if you are also taking the antidepressant fluvoxamine (Luvox).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Rozerem:

  • liver disease
  • sleep apnea (breathing stops while you are asleep)
  • a breathing disorder such as chronic obstructive pulmonary disease (COPD)
  • a history of depression, mental illness, or suicidal thoughts.

FDA pregnancy category C. It is not known whether Rozerem is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Do not use Rozerem without telling your doctor if you are breast-feeding a baby.

Rozerem may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

How should I take Rozerem?

Take Rozerem exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

hp-sleep-disorders-229Take this medication with a full glass of water.

Take Rozerem 30 minutes before your normal bedtime. After you take Rozerem, avoid doing anything other than getting ready for bed.

Avoid taking Rozerem together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Talk with your doctor if your insomnia does not improve after 7 days of using Rozerem. You may need to be checked for other medical illnesses that may cause insomnia.

Store Rozerem at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Rozerem is usually taken as needed, you may not be on a dosing schedule. Rozerem should be taken only within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Rozerem overdose are not known.

What should I avoid while taking Rozerem?

Rozerem can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine. Alcohol may add to sleepiness caused by ramelteon.

Rozerem side effects

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Rozerem and talk with your doctor about another treatment for your sleep disorder. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Rozerem and call your doctor at once if you have a serious side effect such as:

  • unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself
  • a missed menstrual period
  • nipple discharge
  • loss of interest in sex.

Less serious Rozerem side effects may include:

  • drowsiness
  • dizziness
  • headache
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Rozerem?

Before taking Rozerem, tell your doctor if you are taking any of the following drugs:

  • methoxsalen (Oxsoralen)
  • primaquine o thabendazole (Mintezol)
  • rifampin (Rifadin, Rifater, Rifamate, Rimactane)
  • an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin)
  • heart rhythm medication such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil)
  • an antifungal medication such as fluconazole (Diflucan) or ketoconazole (Nizoral)

This list is not complete and there may be other drugs that can interact with Rozerem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Rozerem.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

last updated: 10/2009

Rozerem (ramelteon) full prescribing information

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders

back to:
~ all articles on sleeping disorders

APA Reference
Writer, H. (2019, October 31). Rozerem Patient Information, HealthyPlace. Retrieved on 2019, September 21 from https://www.healthyplace.com/other-info/sleep-disorders/rozerem-patient-information

Last Updated: September 18, 2019

Ramelteon Patient Information

Generic Name: Ramelteon
Brand Names: Rozerem

Ramelteon full prescribing information

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

Ramelteon may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ramelteon?

Do not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

hp-sleep-disorders-227Before taking ramelteon, tell your doctor if you have liver disease, sleep apnea, a breathing disorder such as chronic obstructive pulmonary disease, or a history of depression, mental illness, or suicidal thoughts.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder.

What should I discuss with my healthcare provider before taking ramelteon?

Do not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use ramelteon:

  • liver disease;
  • sleep apnea (breathing stops while you are asleep);
  • a breathing disorder such as chronic obstructive pulmonary disease (COPD); or
  • a history of depression, mental illness, or suicidal thoughts.

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FDA pregnancy category C. It is not known whether ramelteon is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

How should I take ramelteon?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Talk with your doctor if your insomnia does not improve after 7 days of using ramelteon. You may need to be checked for other medical illnesses that may cause insomnia.

Store ramelteon at room temperature away from moisture and heat.

What happens if I miss a dose?

Since ramelteon is usually taken as needed, you may not be on a dosing schedule. Ramelteon should be taken only within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a ramelteon overdose are not known.

What should I avoid while taking ramelteon?

Ramelteon can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking ramelteon. Alcohol may add to sleepiness caused by ramelteon.

Ramelteon side effects

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;

  • a missed menstrual period;
  • nipple discharge; or
  • loss of interest in sex.

Less serious side effects may include:

  • drowsiness;
  • dizziness;
  • headache; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ramelteon Dosing Information

Usual Adult Dose for Insomnia:

8 mg orally once a day, 30 minutes prior to bedtime, as needed for insomnia.

Usual Geriatric Dose for Insomnia:

8 mg orally once a day, 30 minutes prior to bedtime, as needed for insomnia.

What other drugs will affect ramelteon?

Before taking ramelteon, tell your doctor if you are taking any of the following drugs:

  • methoxsalen (Oxsoralen);
  • primaquine o thabendazole (Mintezol);
  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);
  • an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin);
  • heart rhythm medication such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil); or
  • an antifungal medication such as fluconazole (Diflucan) or ketoconazole (Nizoral).

This list is not complete and there may be other drugs that can interact with ramelteon. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about ramelteon.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

last updated: 10/2009

Ramelteon full prescribing information

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders

back to:
~ all articles on sleeping disorders

APA Reference
Writer, H. (2019, October 1). Ramelteon Patient Information, HealthyPlace. Retrieved on 2019, September 21 from https://www.healthyplace.com/other-info/sleep-disorders/ramelteon-patient-information

Last Updated: September 18, 2019

Ambien Patient Information

Brand Names: Ambien
Generic Name: zolpidem

Ambien full prescribing information

What is Ambien?

Ambien is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Ambien is used for the short-term treatment of insomnia (difficulty falling or staying asleep). This medication causes relaxation to help you fall asleep.

Ambien may also be used for purposes other than those listed in this medication guide.

Important information about Ambien

Ambien may cause a severe allergic reaction. Stop taking it and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Ambien will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Ambien is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia). Patient information sheet in plain English.Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.

Ambien can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking this medication. It can increase some of the side effects of Ambien, including drowsiness. This medication may be habit-forming and should be used only by the person it was prescribed for. Ambien should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase Ambien on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of this medication purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide


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What should I discuss with my healthcare provider before taking Ambien?

Ambien will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Ambien and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to zolpidem. Ambien tablets may contain lactose. Use caution if you are sensitive to lactose.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease
  • liver disease
  • lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD)
  • sleep apnea (breathing stops during sleep)
  • myasthenia gravis
  • a history of depression, mental illness, or suicidal thoughts
  • a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Ambien.

FDA pregnancy category C. It is not known whether zolpidem is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of Ambien may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Ambien.

Do not give this medicine to anyone younger than 18 years of age.

How should I take Ambien?

Take Ambien exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ambien comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take Ambien only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.

Take this medication with a full glass of water. Avoid taking Ambien CR with or just after a meal or it may take longer for you to fall asleep. Ambien is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take Ambien for longer than 4 or 5 weeks without your doctor's advice.

You may have withdrawal symptoms if you stop taking this medication after taking it over several days in a row. Do not stop taking this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Withdrawal symptoms include behavior changes, stomach pain, muscle cramps, nausea, vomiting, sweating, anxiety, panic, tremors, and seizure (convulsions). Insomnia symptoms may also return after you stop taking this medication. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking Ambien.

Do not crush, chew, or break an Ambien CR tablet. Swallow the tablet whole. It is specially made to release medicine slowly in the body. Breaking the tablet would cause too much of the drug to be released at one time. Do not swallow the Edluar tablet whole. Place it under your tongue and allow it to dissolve in your mouth without water. Store zolpidem at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Ambien is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have a full 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Ambien can be fatal when it is taken together with other medications that can cause drowsiness.

Symptoms of a Ambien overdose may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking Ambien?

Ambien can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking Ambien during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking Ambien.

Do not drink alcohol while you are taking Ambien. It can increase some of the side effects of Ambien, including drowsiness.

Ambien side effects

Ambien may cause a severe allergic reaction. Stop taking Ambien and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ambien and call your doctor at once if you have any of these serious side effects:

  • depressed mood, thoughts of hurting yourself
  • unusual thoughts, risk-taking behavior, decreased inhibitions, no fear of danger
  • anxiety, aggression, feeling restless or agitated
  • hallucinations, confusion, loss of personality

Less serious Ambien side effects may include:

  • daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed
  • lack of coordination
  • amnesia, forgetfulness
  • vivid or abnormal dreams
  • nausea, constipation
  • stuffy nose, sore throat
  • headache, muscle pain
  • blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ambien?

You may need a lower dose of Ambien if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.

Before taking Ambien, tell your doctor about all other medications you use, especially

  • chlorpromazine (Thorazine)
  • itraconazole (Sporanox), ketoconazole (Nizoral)
  • rifampin (Rifadin, Rimactane, Rifater)
  • antidepressants such as imipramine (Janimine, Tofranil) or sertraline (Zoloft)

This list is not complete and there may be other drugs that can interact with Ambien. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Ambien.

What does my medication look like?

Zolpidem is available with a prescription under the brand name Ambien. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Ambien 5 mg - pink, capsule-shaped, film-coated tablets
  • Ambien 10 mg - white, capsule-shaped, film-coated tablets
  • Ambien CR 6.25 mg - pink round controlled release tablets

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Ambien full prescribing information

last updated: 09/2009

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders

back to:
~ all articles on sleeping disorders

APA Reference
Writer, H. (2019, September 30). Ambien Patient Information, HealthyPlace. Retrieved on 2019, September 21 from https://www.healthyplace.com/other-info/sleep-disorders/ambien-patient-information

Last Updated: September 18, 2019

Ambien: Prescription Sleep Aid (Full Prescribing Information)

Brand Name:Ambien
Generic Name: zolpidem tartrate

Ambien is a sedative-hypnotic drug used as an insomnia treatment for difficulty falling asleep or staying asleep. Usage, dosage, side effects of Ambien.

Contents:

Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Drug Abuse and Dependence
Overdose
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied

Ambien patient information sheet (in plain English)

Indications and Usage

Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies (see Clinical Studies).

The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

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Dosage and Administration

The dose of Ambien should be individualized.

Dosage in adults

The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Ambien dose should not exceed 10 mg per day.


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Special populations

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Ambien in both of these patient populations is 5 mg once daily immediately before bedtime (see Warnings and Precautions).

Use with CNS depressants

Dosage adjustment may be necessary when Ambien is combined with other CNS depressant drugs because of the potentially additive effects (see Warnings and Precautions).

Administration

The effect of Ambien may be slowed by ingestion with or immediately after a meal.

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Dosage Forms And Strengths

Ambien is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.

Ambien 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.

Ambien 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other.

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Contraindications

Ambien is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema (see Warnings and Precautions).

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WARNINGS AND PRECAUTIONS

Need to evaluate for co-morbid diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.

Severe anaphylactic and anaphylactoid reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.

Abnormal thinking and behavioral changes

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization. In controlled trials, < 1% of adults with insomnia who received zolpidem reported hallucinations. In a clinical trial, 7.4% of pediatric patients with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), who received zolpidem reported hallucinations (see Use in Specific Populations).

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with Ambien alone at therapeutic doses, the use of alcohol and other CNS depressants with Ambien appears to increase the risk of such behaviors, as does the use of Ambien at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Ambien should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative/hypnotics.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Withdrawal effects

Following the rapid dose decrease or abrupt discontinuation of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs (see Drug Abuse and Dependence).

CNS depressant effects

Ambien, like other sedative/hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, Ambien should only be taken immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of Ambien. Ambien showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when Ambien is administered with such agents because of the potentially additive effects.

Special populations

Use in the elderly and/or debilitated patients:

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended Ambien dosage is 5 mg in such patients to decrease the possibility of side effects (see Dosage and Administration). These patients should be closely monitored.

Use in patients with concomitant illness:

Clinical experience with Ambien (zolpidem tartrate) in patients with concomitant systemic illness is limited. Caution is advisable in using Ambien in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

Although studies did not reveal respiratory depressant effects at hypnotic doses of zolpidem in normal subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90% was observed in patients with mild-to-moderate sleep apnea when treated with Ambien (10 mg) when compared to placebo. Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Ambien is prescribed to patients with compromised respiratory function. Post-marketing reports of respiratory insufficiency, most of which involved patients with pre-existing respiratory impairment, have been received. Ambien should be used with caution in patients with sleep apnea syndrome or myasthenia gravis.

Data in end-stage renal failure patients repeatedly treated with Ambien did not demonstrate drug accumulation or alterations in pharmacokinetic parameters. No dosage adjustment in renally impaired patients is required; however, these patients should be closely monitored (see Clinical Pharmacology).

A study in subjects with hepatic impairment did reveal prolonged elimination in this group; therefore, treatment should be initiated with 5 mg in patients with hepatic compromise, and they should be closely monitored (see Dosage and Administration) and Clinical Pharmacology).

Use in patients with depression:

As with other sedative/hypnotic drugs, Ambien should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Use in pediatric patients:

Safety and effectiveness of zolpidem have not been established in pediatric patients. In an 8-week study in pediatric patients (aged 6-17 years) with insomnia associated with ADHD, zolpidem did not decrease sleep latency compared to placebo. Hallucinations were reported in 7.4% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations (see Use in Specific Populations).

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Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical trials experience

Associated with discontinuation of treatment:

Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most commonly observed adverse reactions in controlled trials:

During short-term treatment (up to 10 nights) with Ambien at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo treated patients were dizziness (5%) and drugged feelings (3%).

Adverse reactions observed at an incidence of ≥ 1% in controlled trials:

The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (Percentage of patients reporting)
Body System/
Adverse Event *
Zolpidem
(≤10mg)
(N=685)
Placebo
(N=473)
* Reactions reported by at least 1% of patients treated with Ambien and at a greater frequency than placebo.
Central and Peripheral Nervous System    
Headache 7 6
Drowsiness 2 _
Dizziness 1 _
     
Gastrointestinal System    
Diarrhea 1 -

The following table was derived from results of three placebo-controlled long-term efficacy trials involving Ambien (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.

Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (Percentage of patients reporting)
Body System/
Adverse Event *
Zolpidem
(≤10mg)
(N=152)
Placebo
(N=161)
* Reactions reported by at least 1% of patients treated with Ambien and at a greater frequency than placebo.
Autonomic Nervous System    
Dry mouth 3 1
     
Body as a Whole    
Allergy 4 1
Back Pain 3 2
Influenza-like symptoms 2 -
Chest pain 1 -
     
Cardiovascular System    
Palpitation 2 -
     
Central and Peripheral Nervous System    
Drowsiness 8 5
Dizziness 5 1
Lethargy 3 1
Drugged feeling 3 -
Lightheadedness 2 1
Depression 2 1
Abnormal dreams 1 -
Amnesia 1 -
Sleep disorder 1 -
     
Gastrointestinal System    
Diarrhea 3 2
Abdominal pain 2 2
Constipation 2 1
     
Respiratory System    
Sinusitis 4 2
Pharyngitis 3 1
     
Skin and Appendages    
Rash 2 1

Dose relationship for adverse reactions:

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse events.

Adverse event incidence across the entire preapproval database:

Ambien was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with Ambien, they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.

Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system: Frequent: upper respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.

Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.

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Drug Interactions

CNS-active drugs

Since the systematic evaluations of zolpidem in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.

Ambien was evaluated in healthy subjects in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.

An additive effect on psychomotor performance between alcohol and zolpidem was demonstrated (see Warnings and Precautions).

A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life. There was no evidence of an additive effect in psychomotor performance.

Following five consecutive nightly doses of zolpidem 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.

Drugs that affect drug metabolism via cytochrome P450

Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.

A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC0-β of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance.

A randomized, placebo-controlled, crossover interaction study in eight healthy female subjects between five consecutive daily doses of rifampin (600 mg) and a single dose of zolpidem (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (-73%), Cmax (-58%), and T1/2 (-36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem.

A randomized double-blind crossover interaction study in twelve healthy subjects showed that co-administration of a single 5 mg dose of zolpidem tartrate with ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem by a factor of 1.3 and increased the total AUC of zolpidem by a factor of 1.7 compared to zolpidem alone and prolonged the elimination half-life by approximately 30% along with an increase in the pharmacodynamic effects of zolpidem. Caution should be used when ketoconazole is given with zolpidem and consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Ambien with ketoconazole may enhance the sedative effects.

Other drugs with no interaction with zolpidem

A study involving cimetidine/zolpidem and ranitidine/zolpidem combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.

Zolpidem had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in normal subjects.

Drug-laboratory test interactions

Zolpidem is not known to interfere with commonly employed clinical laboratory tests. In addition, clinical data indicate that zolpidem does not cross-react with benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screens.

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Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Ambien should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Oral studies of zolpidem in pregnant rats and rabbits showed adverse effects on the development of offspring only at doses greater than the maximum recommended human dose (MRHD of 10 mg/day). These doses were also maternally toxic in animals. A teratogenic effect was not observed in these studies. Administration to pregnant rats during the period of organogenesis produced dose-related maternal toxicity and decreases in fetal skull ossification at doses 25 to 125 times the MRHD. The no-effect dose for embryo-fetal toxicity was between 4 and 5 times the MRHD. Treatment of pregnant rabbits during organogenesis resulted in maternal toxicity at all doses studied and increased post-implantation embryo-fetal loss and under-ossification of fetal sternebrae at the highest dose (over 35 times the MRHD). The no-effect level for embryo-fetal toxicity was between 9 and 10 times the MRHD. Administration to rats during the latter part of pregnancy and throughout lactation produced maternal toxicity and decreased pup growth and survival at doses approximately 25 to 125 times the MRHD. The no-effect dose for offspring toxicity was between 4 and 5 times the MRHD.

Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. There is a published case report documenting the presence of zolpidem in human umbilical cord blood. Children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy. Cases of severe neonatal respiratory depression have been reported when zolpidem was used with other CNS depressants at the end of pregnancy.

Labor and delivery

Ambien has no established use in labor and delivery (see Pregnancy).

Nursing mothers

Studies in lactating mothers indicate that the half-life of zolpidem is similar to that in young normal subjects (2.6 ± 0.3 hr). Between 0.004% and 0.019% of the total administered dose is excreted into milk. The effect of zolpidem on the nursing infant is not known. Caution should be exercised when Ambien is administered to a nursing mother.

Pediatric use

Safety and effectiveness of zolpidem have not been established in pediatric patients.

In an 8-week controlled study, 201 pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (90% of the patients were using psychoanaleptics) were treated with an oral solution of zolpidem (n=136), or placebo (n=65). Zolpidem did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 4 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent (> 5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%) (see Warnings and Precautions). Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

Geriatric use

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥ 60 years of age. For a pool of U.S. patients receiving zolpidem at doses of ≤ 10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related).

Adverse Event Zolpidem Placebo
Dizziness
Drowsiness
Diarrhea
3%
5%
3%
0%
2%
1%

A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥ 70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses > 10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥ 70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses > 10 mg.

The dose of Ambien in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs (see Warnings and Precautions).

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Drug Abuse And Dependence

Controlled substance

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.

Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.

Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.

Dependence

Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

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Overdose

Signs and symptoms

In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

Recommended treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

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Description

Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

Zolpidem tartrate chemical structure

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.

Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

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Clinical Pharmacology

Mechanism of action

Subunit modulation of the GABAA receptor chloride channel macromolecular complex is hypothesized to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties. The major modulatory site of the GABAA receptor complex is located on its alpha (α) subunit and is referred to as the benzodiazepine (BZ) or omega (ω) receptor. At least three subtypes of the (ω) receptor have been identified.

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs with known hypnotic properties, it interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the (BZ1) receptor preferentially with a high affinity ratio of the alpha1/alpha5 subunits. The (BZ1) receptor is found primarily on the Lamina IV of the sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. This selective binding of zolpidem on the (BZ1) receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.

Pharmacokinetics

The pharmacokinetic profile of Ambien is characterized by rapid absorption from the gastrointestinal tract and a short elimination half-life (T1/2) in healthy subjects.

In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg zolpidem tartrate tablets, the mean peak concentrations (Cmax) were 59 (range: 29 to 113) and 121 (range: 58 to 272) ng/mL, respectively, occurring at a mean time (Tmax) of 1.6 hours for both. The mean Ambien elimination half-life was 2.6 (range: 1.4 to 4.5) and 2.5 (range: 1.4 to 3.8) hours, for the 5 and 10 mg tablets, respectively. Ambien is converted to inactive metabolites that are eliminated primarily by renal excretion. Ambien demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Zolpidem did not accumulate in young adults following nightly dosing with 20 mg zolpidem tartrate tablets for 2 weeks.

A food-effect study in 30 healthy male subjects compared the pharmacokinetics of Ambien 10 mg when administered while fasting or 20 minutes after a meal. Results demonstrated that with food, mean AUC and Cmax were decreased by 15% and 25%, respectively, while mean Tmax was prolonged by 60% (from 1.4 to 2.2 hr). The half-life remained unchanged. These results suggest that, for faster sleep onset, Ambien should not be administered with or immediately after a meal.

Special Populations

Elderly

In the elderly, the dose for Ambien should be 5 mg (see Warnings and Precautions and Dosage and Administration). This recommendation is based on several studies in which the mean Cmax, T1/2, and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (> 70 years), the means for Cmax, T1/2, and AUC significantly increased by 50% (255 vs. 384 ng/mL), 32% (2.2 vs. 2.9 hr), and 64% (955 vs. 1,562 ng∙hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Ambien did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week.

Hepatic Impairment

The pharmacokinetics of Ambien in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20 mg oral zolpidem tartrate dose, mean Cmax and AUC were found to be two times (250 vs. 499 ng/mL) and five times (788 vs. 4,203 ng∙hr/mL) higher, respectively, in hepatically -compromised patients. Tmax did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normal subjects of 2.2 hr (range: 1.6 to 2.4 hr). Dosing should be modified accordingly in patients with hepatic insufficiency (see Dosage and Administration and Warnings and Precautions).

Renal Impairment

The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal failure (mean ClCr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. On day 1, Cmax was 172 ± 29 ng/mL (range: 46 to 344 ng/mL). After repeated dosing for 14 or 21 days, Cmax was 203 ± 32 ng/mL (range: 28 to 316 ng/mL). On day 1, Tmax was 1.7 ± 0.3 hr (range: 0.5 to 3.0 hr); after repeated dosing Tmax was 0.8 ± 0.2 hr (range: 0.5 to 2.0 hr). This variation is accounted for by noting that last-day serum sampling began 10 hours after the previous dose, rather than after 24 hours. This resulted in residual drug concentration and a shorter period to reach maximal serum concentration. On day 1, T1/2 was 2.4 ± 0.4 hr (range: 0.4 to 5.1 hr). After repeated dosing, T1/2 was 2.5 ± 0.4 hr (range: 0.7 to 4.2 hr). AUC was 796 ± 159 ng∙hr/mL after the first dose and 818 ± 170 ng∙hr/mL after repeated dosing. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function. However, as a general precaution, these patients should be closely monitored.

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Nonclinical Toxicology

Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenesis:

Zolpidem was administered to rats and mice for 2 years at dietary dosages of 4, 18, and 80 mg/kg/day. In mice, these doses are 26 to 520 times or 2 to 35 times the maximum 10 mg human dose on a mg/kg or mg/m2 basis, respectively. In rats these doses are 43 to 876 times or 6 to 115 times the maximum 10 mg human dose on a mg/kg or mg/m2 basis, respectively. No evidence of carcinogenic potential was observed in mice. Renal liposarcomas were seen in 4/100 rats (3 males, 1 female) receiving 80 mg/kg/day and a renal lipoma was observed in one male rat at the 18 mg/kg/day dose. Incidence rates of lipoma and liposarcoma for zolpidem were comparable to those seen in historical controls and the tumor findings are thought to be a spontaneous occurrence.

Mutagenesis:

Zolpidem did not have mutagenic activity in several tests including the Ames test, genotoxicity in mouse lymphoma cells in vitro, chromosomal aberrations in cultured human lymphocytes, unscheduled DNA synthesis in rat hepatocytes in vitro, and the micronucleus test in mice.

Impairment of fertility:

In a rat reproduction study, the high dose (100 mg base/kg) of zolpidem resulted in irregular estrus cycles and prolonged precoital intervals, but there was no effect on male or female fertility after daily oral doses of 4 to 100 mg base/kg or 5 to 130 times the recommended human dose in mg/m2. No effects on any other fertility parameters were noted.

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Clinical Studies

Transient insomnia

Normal adults experiencing transient insomnia (n = 462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.

Normal elderly adults (mean age 68) experiencing transient insomnia (n = 35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).

Chronic insomnia

Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™). Adult outpatients with chronic insomnia (n = 75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.

Adult outpatients (n=141) with chronic insomnia were also evaluated, in a double-blind, parallel group, 4-week trial comparing two doses of zolpidem and placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.

Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Ambien.

Studies pertinent to safety concerns for sedative/hypnotic drugs

Next-day residual effects:

Next-day residual effects of Ambien were evaluated in seven studies involving normal subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of Ambien in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.

Rebound effects:

There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Ambien (zolpidem tartrate). There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg.

Memory impairment:

Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Ambien. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Ambien, predominantly at doses above 10 mg.

Effects on sleep stages:

In studies that measured the percentage of sleep time spent in each sleep stage, Ambien has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.

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How Supplied/Storage and Handling

Ambien 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:

NDC Number Size
0024-5401-31 bottle of 100
0024-5401-34 carton of 100 unit dose
0024-5401-50 bottle of 500

Ambien 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:

NDC Number Size
0024-5421-31 bottle of 100
0024-5421-34 carton of 100 unit dose
0024-5421-50 bottle of 500

Store at controlled room temperature 20°-25°C (68°-77°F).

last updated 09/2009

Ambien patient information sheet (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

back to:
~ all articles on sleeping disorders

APA Reference
Writer, H. (2019, September 30). Ambien: Prescription Sleep Aid (Full Prescribing Information), HealthyPlace. Retrieved on 2019, September 21 from https://www.healthyplace.com/other-info/sleep-disorders/ambien-prescription-sleep-aid-full-prescribing-information

Last Updated: September 18, 2019

Caffeine Citrate Patient Information

Generic Name: caffeine citrate
Brand Name: Cafcit

Caffeine citrate, full prescribing information

What is caffeine citrate?

Caffeine citrate is a central nervous system stimulant. It also has effects on the lungs and metabolism.

Caffeine citrate is used to treat breathing problems in premature infants.

Caffeine citrate may also be used for other purposes not listed in this medication guide.

Important information about caffeine citrate

Caffeine citrate should not be given to a child who has had an allergic reaction to it in the past.

Caffeine Citrate Patient InformationBefore using caffeine citrate, tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of caffeine citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using caffeine citrate.

To be sure caffeine citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Before taking caffeine citrate

Caffeine citrate should not be given to a child who has had an allergic reaction to it in the past.

Before using caffeine citrate, tell the doctor if your child is allergic to any drugs, or if the child has:

  • seizures
  • heart disease
  • kidney disease
  • liver disease
  • high or low blood sugar

If your child has any of these conditions, he or she may need a dose adjustment or special tests to safely take this medication.

This medication may be harmful to an unborn baby and should not be taken by a woman who is pregnant. Caffeine citrate should also not be taken by a woman who is breast-feeding a baby.


continue story below

 

 


How should I take caffeine citrate?

Use caffeine citrate exactly as it was prescribed for your child. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on the prescription label.

Caffeine citrate is for short-term use only. Do not use the medication for longer than 12 days without the advice of your child's doctor.

Measure caffeine citrate with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Each bottle of caffeine citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Do not use caffeine citrate if the liquid has changed colors or has particles in it. Call your doctor for a new prescription. Call your doctor if the child's breathing symptoms do not improve after using caffeine citrate.

To be sure caffeine citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Store caffeine citrate at room temperature away from heat and moisture. Do not open a bottle of caffeine citrate until you are ready to give the dose. This medication contains no preservatives.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your child's next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have given your child too much of this medicine.

Overdose symptoms may include loss of appetite, sleep problems, fussiness, or excessive crying.

What should I avoid while taking caffeine citrate?

Avoid giving the child food or drinks that contain caffeine, such as cola or chocolate milk.

last updated 02/2010

Caffeine citrate, full prescribing information

Detailed Info on Signs, Symptoms, Causes, Treatments of Sleep Disorders

back to:
~ all articles on sleeping disorders

APA Reference
Writer, H. (2019, September 28). Caffeine Citrate Patient Information, HealthyPlace. Retrieved on 2019, September 21 from https://www.healthyplace.com/other-info/sleep-disorders/caffeine-citrate-patient-information

Last Updated: September 18, 2019

Indicators that an Eating Disorder Has Led to Suicidal Ideation

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Trigger warning: This post contains a frank discussion of suicide as it pertains to eating disorders and suicidal ideation.

What are the indicators that an eating disorder has led to suicidal ideation? Are there shifts in mood or patterns of behavior to look for in people who battle this disease? How common is suicide in the disordered eating population, and which signs need to be taken seriously as cries for help or intervention?  

How Eating Disorders and Suicidal Ideation Are Connected

Out of all the forms of mental illness, eating disorders have the highest documented risk of suicide, with an annual suicide-related mortality ratio of 7.8 in the 15–24-year-old age bracket and 10.7 in the 25–44-year-old age bracket.1 This connection between eating disorders and suicidal ideation is multifaceted and complex—often those who suffer from an eating disorder feel anxious, isolated, reckless, hopeless, consumed with self-hatred, and burdensome to their family or friends. Over time, these emotions and beliefs can coerce people with eating disorders to view the idea of suicide as their only escape from the mental turbulence and physical behaviors they can no longer control.    

Because suicide is the number-two cause of death in eating disorder patients, aside from cardiac arrest or organ failure,2 it's of critical importance for relatives, friends, therapists, and other clinicians to know the indicators that an eating disorder has led to suicidal ideation, so they can take subsequent actions which just might save a life. Here are some of the main behavioral and emotional signs to watch out for. 

Signs That an Eating Disorder Has Led to Suicidal Ideation 

If those who suffer from an eating disorder exhibit any of these symptoms, it could be a warning of suicidal ideation which needs immediate support and attention—and, in many cases, professional treatment.    

  1. Impulsive actions: A sudden escalation in the use of drugs or alcohol and the participation in rash or harmful activities can indicate a disregard for personal safety and the desire to live.  

  2. Drastic moods: An extreme change in emotions from habitual anger or despair to an abrupt sense of calm can indicate that a decision to end one's own life has been solidified.    

  3. Social isolation: A withdrawal from family members, friends, and other close relationships can indicate that one feels like a burden and, therefore, should not be around to cause more pain.   

  4. Loss of purpose: An abnormal detachment from areas of life that used to bring interest, passion, and excitement can indicate feelings of emptiness and a lack of purpose to continue on. 

  5. Increase in guilt: An outward—often verbalized—expression of guilt or self-deprecation can indicate a struggle to live with the intense shame caused by an eating disorder. 

Do you recognize these indicators of suicidal ideation in loved ones who suffer from an eating disorder? Tell us about it in the comments.

If you feel that you might hurt yourself or someone else, call 9-1-1 immediately.

For more information on suicide, see our suicide information, resources and support section. For additional mental health help, please see our mental health hotline numbers and referral information section.

Sources

  1. Bachmann, S., "Epidemiology of Suicide and the Psychiatric Perspective." International Journal of Environmental Research and Public Health, July 2018.
  2. Kostro, K. et al, "The Current Status of Suicide and Self-Injury in Eating Disorders: A Narrative Review." Journal of Eating Disorders, July 2014.

How to Avoid Blaming Yourself After a Loved One's Suicide

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Trigger warning: This post contains a frank discussion of suicide as it pertains to blaming yourself for a loved one's death by suicide.

Losing a loved one to suicide is an emotional journey that no one anticipates or knows how to react to. As a personal supporter of National Suicide Prevention Month, I wanted to share some of my valuable lessons and stories that taught me how to combat the natural urge to inflict verbal abuse on yourself and to avoid blaming yourself after the death of a loved one by suicide.

How I Learned to Avoid Blaming Myself for a Loved One's Suicide

It was 2008 when my family told me that we had lost my uncle, my secondary father figure, to suicide. It was a complete shock. I'm extremely fortunate that my family was strong, honest and open when discussing the truth with us as children because I learned a lot from observation. My aunt explained that you should avoid blaming yourself during the healing process, and I saw that she never blamed herself, either. She taught me what it was to be forgiving as she also forgave herself. I wouldn't know how powerful her lessons were until I would experience the death of a loved one by suicide again 10 years later.

About seven months ago, my close friend died unexpectedly by suicide. As a child dealing with the death of my uncle, I felt like I had little emotional stake in what happened. I felt far, like a bystander in the grief of his death. This time, I felt entwined in my friend's decision because of the recency of our last conversation, confused because he seemed eager about his future and angry that he left without telling me he would. After weeks of putting myself down and blaming myself for his suicide, I told myself to channel what I had learned about unfair self-directed talk after years of family conversations and classes on mental health.

How to Avoid Blaming Yourself for a Loved One's Suicide

Here are some common thoughts I had and the lessons I used to resist them.

  • "It was my fault."

It is not your fault. Sometimes an unfortunate discussion or event precedes a tragedy, and this is independent of the results that have been forming for a long time before. It can cause an unreal level of devastation regardless, but I learned that the responsibility of someone's mental health and wellbeing did not fall on my singularly, and all of the moving parts that may have led up to death by suicide do not fall on you.

  • "If I would have known, I could have helped more."

Death, particularly by suicide, is not meant to be understood. Part of the frustration I felt in the grieving process was the lack of explanation behind what happened. I thought surely there could've been another way; as a friend in his life, I should have seen this coming and intercepted this. Thinking in terms of what I could have done, though, was one of the most verbally abusive patterns of thinking I inflicted on myself. I tried to remember that it was unhealthy for me to circle back to the past and think of different possibilities because the end result was the same, and I wanted to focus on moving forward.

  • "I should have seen this coming."

What happens is not meant to be analyzed. Initially, I racked my brain trying to think of signs or symptoms of mental illness or emotional instability in my friend. I played detective, running through conversations and trying to assign meaning to what he said to me that made me angry at myself for not deciphering it. Eventually, though, I realized that assigning potential meanings to conversations from my own assumptions was unhealthy and unfair to myself.

Understanding Why You Might Blame Yourself After Losing a Loved One

In my experience, it was easy to focus my grief on the person that had passed away, feeling sorry and confused and sad for their loss of life. However, thinking in these patterns is actually unhealthy for you as you continue moving through life. I found that being kind to yourself as you think to yourself is the key to moving on. The displacement of feelings like anger, frustration, and helplessness toward yourself is understandable, and you should try to remember that these feelings are okay to feel, just not toward yourself in the form of verbal abuse disguised as blame. Here are some strategies I recommend after years of learning.

  • Prioritize healthy self-talk to keep moving forward mentally.
  • It's important to focus your internal dialogue on positivity in the past and healthy progress in the future.
  • Loving and forgiving yourself verbally is the first step towards your own peace in your relationship with yourself.

I eventually formed these three suggestions to cope with grief over losing my loved ones to suicide, and while I didn't learn them as easily as they're laid out above, I hope they can offer some guidance in your own process of understanding.

What process did you go through to stop blaming yourself for your loved one's suicide? Share your observations in the comments.

If you feel that you may hurt yourself or someone else, call 9-1-1 immediately.

For more information on suicide, see our suicide information, resources and support section. For additional mental health help, please see our mental health hotline numbers and referral information section.

Acknowledge the Trauma of a Suicide Attempt to Move Forward

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Trigger warning: This post contains a frank discussion of suicide as it pertains to the trauma of a suicide attempt.

Finding self-love after a traumatic suicide attempt seems like a daunting task. After all, of the many thoughts circling the brain after an event of intended suicide, very few of if any are positive. It's more common to feel fear, shame, and misery. And though the immediate hours, or days, or even weeks after such an attempt may be filled with distractions or adjustments, eventually the question will arise–can I ever learn to love myself after the trauma of a suicide attempt?

Acknowledge the Trauma After a Suicide Attempt

An incredibly important thing to remember after a suicide attempt is that it istrauma. Yes, it is a self-caused one, let's put no buffers around that, it's the truth. But nonetheless, it is a life-changing event that is incredibly difficult to process. Suggesting anyone begin the journey towards self-love after the trauma of a suicide attempt is already a difficult task, but when we are carrying unprocessed trauma, it's downright impossible. It's like asking ourselves to climb a mountain carrying a backpack full of bricks. (We all carry a few bricks, nobody is baggage-free, but a whole backpack? That's way too much.) You have to lessen the load before you can begin the climb.

How we choose to process an event like this can vary, but here are two suggestions:

  1. Start therapy. The hard truth is that the things in your head were or still are bad. Bad enough you made the assessment that ending your life sounded more appealing than continuing to live as you have. Therapists are trained to understand this stuff, and if you find a good one, you're going to get to explore yourself with an expert team-mate. It's worth it. (I suggest looking into EMDR, a type of therapy designed to help process trauma.)
  2. Don't Waste Energy Pretending Everything Is Okay. Though you may be experiencing deep shame around your suicide attempt, trying to hide it is exhausting and, frankly, unnecessary. When we try to hide mental issues, we add to the belief that such things in our society must be hidden. Many of those bricks in your backpack come from trying to stay hush-hush about this event. You don't need to start a podcast or scream it from the mountaintops, but a suicide attempt is now a part of your history–accept it, stay open about it, and release the fear that people will find out. (Also, from a practical standpoint, the people around you probably know about it already, these things spread like wildfire.)

I discuss recognizing the trauma after a suicide attempt more deeply in the following video:

Moving Forward After the Trauma of a Suicide Attempt

One of the most important life skills we can learn is how to accept responsibility for the things we do. Ever met someone who refuses to admit they are anything but correct? We have a natural reaction to these people–we stop wanting to connect with them. Instead, we reach towards the people who are able to admit fault and still be okay with themselves. These are the people who have learned self-forgiveness. 

After a suicide attempt is a time when we can learn to tap into self-forgiveness. It's not easy, of course, but there is incredible power in learning to release the self-blame that often follows a suicide attempt. We learn to tell ourselves that life is filled with stumbles and falls and that we can't prevent them all. We can only pick ourselves up and keep going. 

How are you moving forward after experiencing the trauma of a suicide attempt? Let us know in the comments.

If you feel that you may hurt yourself or someone else, call 9-1-1- immediately.

For more information on suicide, see our suicide information, resources and support section. For additional mental health help, please see our mental health hotline numbers and referral information section. 

Suicidal Ideation in Addiction Recovery: Devastating Effects

Posted on:

Trigger warning: This post contains a frank discussion of suicide as it pertains to suicidal ideation in addiction recovery.

Suicidal ideation is a concept I've grown to be incredibly close to in my addiction recovery journey. Most people sweep suicidal ideation into the same categories as suicidal thoughts or even suicidal attempts, however, it's not quite the same as either of those. Think of suicidal ideation as the "monster before the monster," it's not quite to the level of building a plan or constructing thoughts together, but it's pretty close. In my addiction recovery, suicidal ideation has been a constant battle to face, and for the longest time, I didn't even know or understand the severity of it.

What is Suicidal Ideation?

If you're reading this post, I would bet that you already have a preconceived definition and idea of suicide, so there's no need for me to intellectually define the term. Instead, I want to highlight the word ideation. According to Merriam-Webster, ideation is the act of forming or entertaining ideas. 

The concept of forming or entertaining an idea is much more subtle than the commonly noted symptom of suicidal thoughts. Ideation is something that is passive, yet deadly. Ideation creeps up on you and slyly whispers how death could feel nice and how pleasant it must be to no longer exist.

Suicidal thoughts are often a growing and consistent pattern, but suicidal ideation can slip in and out of your mind a hundred times before you even realize what's really going on. 

The Role of Suicidal Ideation in My Addiction Recovery

When I was recovering from my addiction (and even beyond my initial recovery) I was repeatedly, yet so subtly tempted by the idea of death. I never made a single suicide plan, actually, the idea of it sounded quite terrifying to me. Suicidal ideation didn't feel like a suicidal plan to me, it felt warm and comforting and oddly hopeful.

It felt remarkably good to fantasize about the idea of not being present in my current struggle. I wasn't actually planning to die so it didn't feel harmful to me, in fact, it didn't even feel real because I'd never shared it with anybody else.

It wasn't until this year that I began to understand the devastating effects of my harmful thoughts and suicidal ideations in my addiction recovery. I had no idea how wrapped up I'd become in the idea of dying and how peaceful I was about the possibility of death.

Addiction recovery can be daunting, I think we all know that; and of course, most of us are desperately looking for some kind of escape from our suffering especially in early recovery. Suicidal ideation and the "entertaining" of those thoughts became some kind of sick escape for me, a way for me to forget about some of my sufferings ("Using Suicidal Ideation as a Depression Coping Mechanism").

Is Suicidal Ideation in Addiction Recovery Actually Harmful?

I can't say one way or another what the real long-term goal was with my suicidal ideation in addiction recovery. I can say that over time my thoughts did grow stronger and more consistent, but thankfully, I never pursued a plan or anything of the like. 

Some might conclude that this resolution means that suicidal ideation isn't really that harmful, but I would tell those people that they are totally and completely wrong.

Suicidal ideation may not be the thing that takes my life, but it did take the life out of my days. When you become obsessed or fixated on the idea of death or just "not being here," you are no longer present in your own life. Instead, you are longing for a time or a place where you no longer exist and let me tell you that is a really scary place to be.

Ideations and the forming of thoughts like these rob you of your peace and emotional presence here on earth. It's hard to maintain relationships or plan for a pleasant future if you're desperately longing to just not exist anymore. 

So no, suicidal ideation might not take your life in the traditional sense, but it can rob you of so much and only further the notion of you wishing you were dead, and for some, that can be nearly just as damaging.

How has suicidal ideation affected your addiction recovery? Share your thoughts in the comments.

If you feel that you may hurt yourself or someone else, call 9-1-1 immediately.

For more information on suicide, see our suicide information, resources, and support section. For additional mental health help, please see our mental health hotline numbers and referral information section.

Suicidal Ideation During Mania from Schizoaffective Disorder

Posted on:

Trigger warning: This post contains a frank discussion of suicide as it pertains to suicidal ideation during mania.

It was the summer of 2006. I had just completed my master’s degree in photography from Columbia College Chicago. My schizoaffective mania was taking over—yet, I felt very suicidal because of mania from schizoaffective disorder. It all came to a head on a trip to Door County with my parents and my younger brother.

Suicidal Ideation During Mania

You may find it strange that I felt suicidal while in the throes of schizoaffective mania, those usual periods of hyper euphoria. I don’t tend to have the kind of mania in which I feel incredibly happy. My mania has a lot more to do with anxiety and irritability. So I hope this explains why I felt schizoaffective suicidal ideation while manic ("What Is a Manic Episode? What Do Manic Episodes Feel Like?").

Also, I was feeling more suicidal ideation than acute suicidality. Suicidal ideation means I was thinking about suicide a lot but I didn’t have a plan to actually do anything to hurt myself.

It was a very difficult summer for me because I had been in school my whole life—I had gone from high school and college straight through to graduate school—and I didn’t know what I was going to do next. I hadn’t met my husband yet.

So this trip to Door County occurred during a very difficult time for me. It didn’t help that all of us—me, one of my brothers, and our parents—were packed into a hotel suite, even though it had three bedrooms. It also didn’t help that I wasn’t allowed to smoke in my hotel room. (I ended up smoking in the room anyway.)

Schizoaffective Disorder and a Suicide Note During Mania

One night while we were there, I wrote a suicide note around midnight and read it to my family. My mom said to take my medication and to page my psychiatrist. My psychiatrist said I should go to bed; my history suggested I wouldn’t follow through on my note. But I couldn’t go to bed because my sleep cycle was reversed.

Earlier that night, I had called a good friend and told her I was going to die by suicide. She started crying. Then, at around six the following morning, I called other friends telling them the same thing. One of my friends called the front desk of the hotel where we were staying and the desk associate called our room.

As I said, I didn’t have a plan for my suicide. I was feeling very frenetic and had been sending everyone in my contacts list cryptic emails all summer. Even though it was “just” suicidal ideation, and even though my behavior could have been seen as “just” a cry for help, my parents and psychiatrist were right to take it seriously. 10 percent of people with schizoaffective disorder die by suicide. I was enrolled in dialectical behavior therapy (DBT) (DBT) shortly after. That and a medication change calmed me down.

The main point I want to make here is that all threats of suicide, no matter how silly or theatrical they may seem, should be taken seriously. It could save—or at least improve—a life. It certainly has improved mine.

Have you ever experienced suicidal ideation during mania? What was that like for you? Leave your thoughts in the comments.

If you feel that you may hurt yourself or someone else, call 9-1-1 immediately.

For more information on suicide, see our suicide information, resources and support section. For additional mental health help, please see our mental health hotline numbers and referral information section.