Edluar Patient Information

Brand Name: Edluar, Ambien
Generic Name: zolpidem tartrate

Edluar full prescribing information

What is Edluar?

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

Edluar sublingual tablets are used for the short treatment of insomnia where individuals are finding it difficult to fall asleep.

Edluar sublingual tablets may also be used for other purposes not listed in this medication guide.

Important information about Edluar

Edluar sublingual tablets may cause a severe allergic reaction. Stop taking the tablets 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. Edluar 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 Edluar and talk with your doctor about another treatment for your sleep disorder.

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

Before taking Edluar

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

Do not use this medication if you are allergic to zolpidem.

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

• 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; or
• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether Edluar 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 Edluar without telling your doctor if you are breast-feeding a baby.

The sedative effects of Edluar 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 Edluar.

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

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How should I take Edluar?

Take Edluar sublingual tablets exactly as they were 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.

The Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed whole and the tablet should not be taken with water. Ask your doctor or pharmacist if you have any questions.

Take Edluar 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.

Edluar 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 Edluar after taking it over several days in a row. Do not stop taking Edluar 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 Edluar. 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 Edluar.

Store Edluar sublingual tablets at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Edluar 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 Edluar 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 Edluar?

Edluar 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 Edluar 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 Edluar.

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

Edluar side effects

Edluar may cause a severe allergic reaction. Stop taking Edluar 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 Edluar 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 Edluar 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; or
• blurred vision.

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 Edluar?

You may need a lower dose of Edluar 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 Edluar, tell your doctor about all other medications you use, especially:

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

This list is not complete and there may be other drugs that can interact with Edluar. 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 Edluar.

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.

Edluar full prescribing information

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

Last Updated: 05/2009

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