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GENERIC NAME: zaleplon

BRAND NAME: Sonata

DRUG CLASS AND MECHANISM: Zaleplon is a hypnotic (a medication that induces sleep) that is used for treating insomnia. It is chemically unrelated to the benzodiazepine class of medications for sleep, e.g. lorazepam (Ativan), oxazepam (Serax), flurazepam (Dalmane), triazolam (Halcion), and temazepam (Restoril), but it has similar effects because it attaches to the same receptors on nerve cells as these well-known medications. It was approved by the FDA in 1999.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Capsules, 5mg, 10mg (green).

STORAGE: Capsules should be stored at room temperature, between 15 and 30°C (59-86°F).

PRESCRIBED FOR: Zaleplon is used for the short-term (7 to 10 days) treatment of insomnia.

DOSING: Zaleplon is taken at bedtime for assistance in falling asleep. Because of its short duration of activity, it is not effective for persons who wake up during the night. Zaleplon should be taken immediately before bedtime or after going to bed and experiencing difficulty falling asleep. Taking zaleplon with a high-fat meal slows its absorption and may also slow its onset of action.

DRUG INTERACTIONS: Rifampin reduces the amount of zaleplon in the blood by more than 80%. This could lead to a decrease in zaleplon's activity. Cimetidine (Tagamet) can greatly increase the amount of zaleplon in the blood; if cimetidine must be used, lower doses of zaleplon are suggested. The drowsiness that can occur with zaleplon is accentuated by alcohol, and, therefore, patients taking zaleplon should not drink alcoholic beverages.

PREGNANCY: There are no studies of zaleplon in pregnant women. In studies in rats, damage to fetuses has been reported. Therefore, zaleplon is not suggested for pregnant women unless the physician feels the benefits outweigh the potential risks.

NURSING MOTHERS: A small amount of zaleplon is excreted in breast milk. Because the effects of zaleplon on nursing infants are unknown, it is recommended that nursing mothers not take zaleplon.

SIDE EFFECTS: The most common side effects associated with zaleplon are headache, drowsiness, dizziness, amnesia, stomach ache, and muscle pain. Studies have shown that zaleplon has a potential for abuse similar to benzodiazepine.

Reference: FDA Prescribing Information


Last Editorial Review: 1/16/2000 1:07:00 PM




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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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