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Article: Sonata
- Article from:
- Formulary
- Article date:
- October 1, 1999
- Author:
CopyrightCopyright Advanstar Communications, Inc. Oct 1999. Provided by ProQuest LLC. (Hide copyright information)
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Nonbenozodiazepine hypnotic agent
for Tx of insomnia in adults and elderly Zaleplon capsules Wyeth-Ayerst
The FDA has approved zaleplon for the short-term treatment of insomnia. The drug is a nonbenzodiazepine hypnotic agent of the pyrazolopyrimidine class.
Labeling states that because zaleplon has a very short half-life, clinical trials focused on decreasing sleep latency, with less attention paid to sleep duration and number of awakenings, for which no consistent differences from placebo were demonstrated.
Approval was based on studies of both transient and chronic insomnia. In three studies of adults with transient insomnia (N = 264), zaleplon 10 mg, but not 5 mg, was superior to ...