Zolpidem, Patient Information

Generic Name: zolpidem
Brand Names: Ambien, Ambien CR, Edluar

Zolpidem full prescribing information

What is zolpidem?

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

Zolpidem is used to treat insomnia. The immediate-release form of zolpidem is Ambien, which is used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Your doctor will determine which form of this medicine is best for you.

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

Important information about zolpidem

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem 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. Zolpidem will make you fall asleep. Never take this medicine 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 zolpidem and talk with your doctor about another treatment for your sleep disorder.

Zolpidem 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 zolpidem 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 zolpidem. It can increase some of the side effects of zolpidem, including drowsiness.

Zolpidem may be habit-forming and should be used only by the person it was prescribed for. This medicine 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 zolpidem 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 zolpidem 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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Before taking zolpidem

Zolpidem 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 zolpidem and talk with your doctor about another treatment for your sleep disorder.

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

Before taking zolpidem, 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 this medication.

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. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use without telling your doctor if you are breast-feeding a baby.

The sedative effects of zolpidem 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 zolpidem.

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

How should I take zolpidem?

Take zolpidem 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.

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

Take zolpidem 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 zolpidem 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. Zolpidem 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 this medicine for longer than 4 or 5 weeks without your doctor's advice.

You may have withdrawal symptoms if you stop taking zolpidem after taking it over several days in a row. Do not stop taking this medicine 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 zolpidem. 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 zolpidem.

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 an 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 zolpidem 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 zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

What should I avoid while taking zolpidem?

Zolpidem 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 zolpidem 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 zolpidem 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 this medicine.

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

Zolpidem side effects

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem 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 zolpidem 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, changes in personality

Less serious zolpidem 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.

Zolpidem Dosing Information

Usual Zolpidem Adult Dose for Insomnia:

Immediate release: 10 mg orally once a day immediately before bedtime. The recommended duration of therapy is generally 7 to 10 days.

Controlled release: 12.5 mg orally once a day immediately before bedtime.

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.

The safety of immediate release zolpidem has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.

Usual Geriatric Dose for Insomnia:

Immediate release: 5 mg orally once a day immediately before bedtime. The recommended duration of therapy is generally 7 to 10 days. The dosage can be titrated up to 10 mg nightly if necessary depending on the patient's response.

Controlled release: 6.25 mg orally once a day immediately before bedtime.

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.

The safety of immediate release zolpidem has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.

What other drugs will affect zolpidem?

You may need a lower dose of zolpidem 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 zolpidem, 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 zolpidem. 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 zolpidem.

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

last updated 11/2009

Zolpidem full prescribing information

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