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Drugs Approved by the FDA

Drug Name: Sonata

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: American Home Products
Approval Status: Approved August 1999
Treatment for: Neurology; Psychiatry

General Information

Sonata (zaleplon) has been approved for the short-term (generally 7-10 days) treatment of insomnia in adults, including elderly patients. Sonata is not a sleep maintenance drug. Rather it remains at its binding site for only a short time, and is rapidly eliminated after sleep is initiated so the patient's natural sleep processes can take over. The recommended dose for most non-elderly adults is one 10-mg capsule; elderly patients are advised to take one 5-mg capsule.

Clinical Results

In clinical studies, Sonata has been shown to be effective in helping individuals fall asleep fast (within 30 minutes), allowing the natural sleep process to take over.

Side Effects

In clinical studies, among the most common side effects with Sonata are headache, drowsiness, dizziness, none of which were significantly different from patients receiving placebo.

Mechanism of Action

Sonata is the first in a new chemical class of nonbenzodiazepine compounds, and has a unique mechanism of action and pharmacokinetic profile, which allows for flexible administration.


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Drug listing last updated on June 20, 2008

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