Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Neurology | Psychiatry/Psychology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: American Home Products
Approval Status: Approved August 1999
Treatment Area: Neurology; Psychiatry
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.
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.
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.