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US Brand Names

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Description

Zolpidem 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.

This product is available in the following dosage forms:

• Tablet, Extended Release
• Tablet

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Before Using

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 this medicine, the following should be considered:

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.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of zolpidem in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects .

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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.

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Proper Use

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.

You should swallow the extended-release tablets whole. Do not crush or chew them.

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 should be taken without food on an empty stomach. It will 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.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of insomnia (trouble in sleeping):
  • For oral dosage form (tablets):
    • Adults—10 milligrams (mg) once a day at bedtime.
    • Older adults—5 mg once a day at bedtime.
    • Children—Use and dose must be determined by the doctor .
  • For oral dosage form (extended-release [long-acting] tablets):
    • Adults—12.5 milligrams (mg) once a day at bedtime.
    • Older adults—6.25 mg once a day at bedtime.
    • Children—Use and dose must be determined by the doctor .

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

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.

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away .

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.

Zolpidem may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .

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Side Effects

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 immediately if any of the following side effects occur:

• Clumsiness or unsteadiness
• Confusion
• Mental depression

• Dizziness, lightheadedness, or fainting
• Falling
• 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

Get emergency help immediately if any of the following symptoms of overdose occur:

• Clumsiness or unsteadiness (severe)
• Dizziness (severe)
• Double vision or other vision problems
• Drowsiness (severe)
• Nausea (severe)
• Slow heartbeat
• Troubled breathing
• Vomiting (severe)

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Sleepiness or unusual drowsiness

• Abdominal or stomach pain
• Abnormal or decreased touch sensation
• Abnormal sensation of movement
• Appetite disorder
• Balance disorder
• Binge eating
• Bladder pain
• Bloody or cloudy urine
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Change in hearing
• Chest discomfort
• Chills
• Confusion about identity, place, and time
• Constipation
• Continuing ringing or buzzing or other unexplained noise in ears
• Daytime drowsiness
• Diarrhea
• Difficult, burning, or painful urination
• Difficulty in moving
• Difficulty swallowing
• Discouragement
• Double vision or other vision problems
• Drugged feelings
• Dryness of mouth
• Ear drainage
• Earache
• Eye redness
• False or unusual sense of well-being
• Fear
• Feeling of unreality
• Feeling sad or empty
• Fever
• Flatulence
• Frequent bowel movements
• Frequent urge to urinate
• General feeling of discomfort or illness
• Generalized slowing of mental and physical activity
• Headache
• Hearing loss
• Heartburn
• Hives or welts
• Itching ears
• Joint pain
• Lack of appetite
• Lack of feeling or emotion
• Lack or loss of self-control
• Lack or loss of strength
• Longer or heavier menstrual periods
• Loss of balance
• Loss of interest or pleasure
• Memory problems
• Mood swings
• Muscle aches, cramping, pain, or stiffness
• Nausea
• Nervousness
• Nightmares or unusual dreams
• Pain in joints
• Redness of skin
• Redness or soreness of throat
• Sense of detachment from self or body
• Shortness of breath or troubled breathing
• Skin rash
• Skin wrinkling
• Sneezing
• Sore throat
• Stress symptoms
• Stuffy or runny nose
• Swollen joints
• Tiredness
• Trouble concentrating
• Trouble sleeping
• Vision blurred
• Visual depth perception altered
• Vomiting

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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