In the U.S.—

• Sedative–hypnotic

Zaleplon ( ZAL–e–plon) belongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Zaleplon is used to treat insomnia (trouble sleeping). 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:

Oral
• Capsules (U.S.)

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 zaleplon only when you are able to get at least 4 hours of sleep 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 zaleplon, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to zaleplon. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Zaleplon has not been studied in pregnant women. However, studies in pregnant animals have shown that zaleplon 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 you doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Zaleplon passes into breast milk, but the effect on nursing babies is unknown

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of zaleplon in children younger than 18 years with adults.

Older adults— Elderly patients are usually more sensitive than younger adults to the effects of zaleplon.

Other medicines—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 zaleplon, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol (with chronic use) or
• Barbiturates, especially phenobarbital or
• Carbamazepine (e.g., Tegretol) or
• Glutethimide (e.g., Doriglute) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Primidone (e.g., Mysoline) or
• Rifampin (e.g., Rifadin)—These medicines may decrease the effectiveness of zaleplon

• Cimetidine (e.g., Tagamet)—Cimetidine may interfere with the breakdown of zaleplon in the body, possibly leading to unwanted effects

• Other central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (medicine for depression)—The CNS depressant effects of either these medicines or zaleplon may be increased, possibly leading to unwanted effects

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)— Dependence on zaleplon may develop

• Breathing problems or
• Mental depression—Zaleplon may make the condition worse
• Liver disease— Higher blood levels of zaleplon 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 zaleplon 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 at least 4 hours of sleep.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.

Zaleplon may be taken with or without food or on a full or empty stomach. However, taking this medicine with or immediately after a heavy or a high fat meal may make zaleplon not work as fast.

Dosing—

The dose of zaleplon 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 zaleplon. If your dose is different, do not change itunless your doctor tells you to do so

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • 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 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—

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 zaleplon 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 central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds: sedatives, tranquilizers, or sleeping medicines; 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 zaleplon is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to zaleplon before you drive, use machines, or do anything else that could be dangerous if you are dizzy, unsteady, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while taking zaleplon, 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, hallucinations (seeing, hearing, smelling, or feeling things that are not there), and unusual excitement, nervousness, or irritability.

If you will be taking zaleplon 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 zaleplon 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 zaleplon or taking alcohol or other CNS depressants with zaleplon may lead to breathing problems and unconsciousness. Some signs of an overdose are clumsiness or unsteadiness, confusion, severe drowsiness, low blood pressure, unusual dullness or feeling sluggish, 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:

• Less common

• Anxiety;  blurred or double vision;  not feeling like oneself 

• Rare
  • Nosebleed;  seeing, hearing, smelling, or feeling things that are not there 
  
  

• Symptoms of overdose
  • Confusion;  clumsiness or unsteadiness, severe;  dizziness or fainting;  drowsiness, severe;  weak muscle tone;  troubled breathing;  unusual dullness or feeling sluggish 
  
  

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:

• More common

• Dizziness;  headache ;  muscle pain;  nausea 

• Less common
  • Abdominal pain;  burning, prickling, or tingling sensation;  constipation ;  cough;  difficulty concentrating;  drowsiness;  dryness of mouth;  excess muscle tone;  eye pain;  fever;  heartburn, indigestion, or acid stomach;  itching;  itching or burning eyes;  joint stiffness and/or pain ;  memory loss;  menstrual pain;  mental depression;  nervousness;  sensitive hearing;  severe headache ;  shortness of breath;  skin rash;  tightness in chest;  trembling or shaking;  troubled breathing;  unusual weakness or tiredness ;  wheezing  
  
  

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 period of time, check with your doctor if you notice any of the following side effects:

• Abdominal and muscle cramps;  convulsions (seizures);  increased sweating;  sadness;  trembling or shaking;  vomiting