Zolpidem Treatment Report

Precautions

Instructions

Side Effects

Interactions

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. Zolpidem 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; or
• 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. This medication may be harmful to an unborn baby. 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 this medication 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.

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.

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 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 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 zolpidem.

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

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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.

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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 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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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); 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 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.

Ambien, Ambien CR, and zolpidem

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