zaleplon, Sonata

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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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, for example, 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: Yes

PRESCRIPTION: Yes

PREPARATIONS: Capsules: 5 and 10 mg

STORAGE: Capsules should be stored at room temperature, between 20-C (68-77 F).

PRESCRIBED FOR: Zaleplon is used for the short-term treatment of insomnia. It decreases the time to the onset of sleep and was used for up to 5-weeks in clinical trials. It does not increase total sleep time or decrease the number of awakenings.

DOSING: The recommended dose is 5 to 20 mg 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 increase the amount of zaleplon in the blood by 85% by reducing the breakdown of zaleplon in the liver. If cimetidine must be used, lower doses of zaleplon are suggested. Ketoconazole (Nizoral, Extina, Xolegel, Kuric), erythromycin and similar drugs that reduce breakdown of drugs in the liver also increase blood concentrations of zaleplon. The drowsiness that can occur with zaleplon is accentuated by alcohol, and, therefore, patients taking zaleplon should not drink alcoholic beverages. Imipramine (Tofranil, Tofranil-PM) and thioridazine also increase drowsiness when combined with zaleplon.

PREGNANCY: There are no studies of zaleplon in pregnant women. In studies in rats, damage to fetuses were reported. Therefore, zaleplon is not recommended 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 benzodiazepines. Patients may experience rebound insomnia on the first night after stopping zaleplon. Zaleplon can cause abnormal behavior or thinking or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so). If these side effects occur, zaleplon should be discontinued.

Reference: FDA Prescribing Information

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