ZALEPLON (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Sonata

? Not commercially available in Canada.

Category

• Sedative-hypnotic

Description

Zaleplon (ZAL-e-plon) belongs to the group of medicinescalled central nervous system (CNS) depressants (medicines that make youdrowsy or less alert). Zaleplon is used to treat insomnia (trouble sleeping).In general, when sleep medicines are used every night for a long time, theymay lose their effectiveness. In most cases, sleep medicines should be usedonly for short periods of time, such as 1 or 2 days, and generally for nolonger than 1 or 2 weeks.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Capsules (U.S.)

Before Using This Medicine

Sleep medicines may causea special type of memory loss or "amnesia". When this occurs, a person doesnot remember what has happened during the several hours between use of themedicine and the time when its effects wear off. This is usually not a problemsince most people fall asleep after taking the medicine. In most instances,memory problems can be avoided by taking zaleplon only when you are able toget at least 4 hours of sleep before you need to be active again. Be sureto 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 beweighed against the good it will do. This is a decision you and your doctorwill make. For zaleplon, the following should be considered:

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

Pregnancy?Zaleplon has not been studied in pregnant women. However, studiesin pregnant animals have shown that zaleplon slows down the development ofthe 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 pregnantor if you may become pregnant.

Breast-feeding?Zaleplon passes into breast milk, but the effect on nursingbabies 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 childrenyounger than 18 years with adults.

Older adults? Elderly patients are usually more sensitive than younger adultsto the effects of zaleplon.

Other medicines?Although certain medicines should not be used togetherat all, in other cases two different medicines may be used together even ifan interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. When you are taking zaleplon,it is especially important that your health care professional know if youare 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 effectivenessof zaleplon

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

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

Other medical problems?The presence of other medical problemsmay affect the use of zaleplon. Make sure to tell your doctor if you haveany other medical problems, especially

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)? Dependence on zaleplonmay 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.

Proper Use of This Medicine

Take this medicine only as directed by your doctor.Do not take more of it, do not take it more often, and do not takeit for a longer time than your doctor ordered. If too much is taken, it maybecome 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 notpermit you to get at least 4 hours of sleep.If you must wake up beforethis, 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 highfat 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 yourdoctor 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 determinedby doctor

Missed dose?If you miss a dose of this medicine, skip the missed doseand 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Ifyou think you need to take zaleplon for more than 7 to 10 days, be sure todiscuss it with your doctor. Insomnia that lasts longer than this may be asign of another medical problem.

This medicine will add to the effects of alcohol and other central nervoussystem (CNS) depressants (medicines that cause drowsiness). Some examplesof CNS depressants are antihistamines or medicine for hay fever, other allergiesor colds: sedatives, tranquilizers, or sleeping medicines; prescription painmedicine or narcotics; barbiturates; medicine for seizures; muscle relaxants;or anesthetics, including some dental anesthetics. Checkwith your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to becomedrowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they arenormally. Even though zaleplon is taken at bedtime, it may cause some peopleto feel drowsy or less alert on arising. Make sure youknow how you react to zaleplon before you drive, use machines, or do anythingelse that could be dangerous if you are dizzy, unsteady, or are not alertor able to see well.

If you develop any unusual and strange thoughts or behavior while takingzaleplon, be sure to discuss it with your doctor. Some changes that have occurredin people taking this medicine are like those seen in people who drink alcoholand then act in a manner that is not normal. Other changes may be more unusualand 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 withoutfirst checking with your doctor. Your doctor may want you to reduce graduallythe amount you are taking before stopping completely. Stopping this medicinesuddenly may cause withdrawal side effects.

After taking zaleplon for insomnia, you may have difficulty sleeping (reboundinsomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken anoverdose of this medicine, get emergency help at once. Taking an overdoseof zaleplon or taking alcohol or other CNS depressants with zaleplon maylead to breathing problems and unconsciousness. Some signs of an overdoseare clumsiness or unsteadiness, confusion, severe drowsiness, low bloodpressure, unusual dullness or feeling sluggish, and troubled breathing.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects may occur, if theydo occur they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Less common