US Brand Names
Zolpidem (ZOLE-pi-dem) belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Zolpidem is used to treat insomnia (trouble in sleeping). Zolpidem helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.
This medicine is available only with your doctor's prescription, in the following dosage form:
Sleep medicines may cause a special type of memory loss or ``amnesia''. When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zolpidem only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For zolpidem, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to zolpidem. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Zolpidem has not been studied in pregnant women. However, studies in pregnant animals have shown that zolpidem slows down the development of the offspring when given to the mother in doses many times the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.
Although zolpidem passes into breast milk, it has not been reported to cause problems in nursing babies.
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of zolpidem in children with use in other age groups.
Confusion and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking zolpidem, it is especially important that your health care professional know if you are taking any of the following:
• Other central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])-The CNS depressant effects of either these medicines or zolpidem may be increased, possibly leading to unwanted effects
Other medical problems
The presence of other medical problems may affect the use of zolpidem. Make sure you tell your doctor if you have any other medical problems, especially:
• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)-Dependence on zolpidem may develop
• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Mental depression or
• Sleep apnea (temporary stopping of breathing during sleep)-Zolpidem may make these conditions worse
• Kidney disease or
• Liver disease-Higher blood levels of zolpidem may result, increasing the chance of side effects
Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).
Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.
Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours) . If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.
Zolpidem may be taken with or without food or on a full or empty stomach. It may work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.
The dose of zolpidem will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of zolpidem. If your dose is different, do not change it unless your doctor tells you to do so.
The number of tablets that you take depends on the strength of the medicine.
• For oral dosage form (tablets):
o For the treatment of insomnia (trouble in sleeping):
§ Adults-10 milligrams (mg) at bedtime.
§ Older adults-5 mg at bedtime.
§ Children up to 18 years of age-Use and dose must be determined by the doctor.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well .
If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.
After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once . Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur :
Clumsiness or unsteadiness; confusion-more common in older adults; mental depression.
Dizziness, lightheadedness, or fainting; falling-more common in older adults; fast heartbeat; hallucinations (seeing, hearing, or feeling things that are not there); skin rash; swelling of face; trouble in sleeping; unusual excitement, nervousness, or irritability; wheezing or difficulty in breathing.
Symptoms of overdose
Clumsiness or unsteadiness (severe); dizziness (severe); double vision or other vision problems; drowsiness (severe); nausea (severe); troubled breathing; slow heartbeat; vomiting (severe).
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
Abdominal or stomach pain; daytime drowsiness; diarrhea; double vision or other vision problems; drugged feelings; dryness of mouth; general feeling of discomfort or illness; headache; memory problems; nausea; nightmares or unusual dreams; vomiting.
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects:
Abdominal or stomach cramps or discomfort; agitation, nervousness, or feelings of panic; convulsions (seizures); flushing; lightheadedness; muscle cramps; nausea; sweating; tremors; uncontrolled crying; unusual tiredness or weakness; vomiting; worsening of mental or emotional problems.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
January 20, 2000