Brand Name: Sonata
Active Ingredient: zaleplon
Indication: Treatment of short-term insomnia
Company Name: Wyeth-Ayerst Laboratories, Inc.
Availability: Approved for marketing in the US on 16 August 1999
According to the National Sleep Foundation, insomnia affects nearly 83 million Americans; however, many people avoid sleep aids for fear of next-day drowsiness. Sonata has been shown to greatly reduce the incidence of next-day effects. It is the first in a new class of nonbenzodiazepine (pyrazolopyrimidine) compounds that possess a mechanism of action that differs from those of currently used sleep aids.
How It Works
Sonata (zaleplon) interacts with the GABA-BZ receptor-chloride channel macromolecular complex. Unlike other hypnotic agents, it remains at the binding site only until sleep is initiated. At this point, it is rapidly eliminated, allowing the natural sleep process to occur. The effects of Sonata last for four hours. This enables the patient to take Sonata in the middle of the night and not experience severe next-day effects.
Sonata (zaleplon): Clinical Study Results
Sonata was studied in 2,800 patients experiencing transient insomnia or chronic insomnia. Three studies focused on 1,019 elderly patients, who ranged in age from 65 to 85 years. A double-blind, parallel-group trial, conducted in a sleep laboratory, examined the effects of Sonata in patients with transient insomnia. The study, which compared Sonata 5 mg and 10 mg with placebo, found the 10 mg dose to be superior to placebo in decreasing latency to persistent sleep (LPS), a polysomnographic measure of time to sleep onset (TSO).
Several studies examining patients with chronic insomnia were conducted. Three double- blind, parallel-group outpatient studies, one lasting 2 weeks and the other two lasting 4 weeks, compared the effects of 5 mg, 10, mg, and 20 mg Sonata with placebo on TSO. Sonata 10 mg and 20 mg were consistently superior to placebo for TSO; whereas, Sonata 5 mg was less consistently effective than 10 mg and 20 mg. Sleep latency with the 10 mg and 20 mg doses was 10-20 minutes (15-30%) less than with placebo. Five double-blind, parallel-group sleep laboratory studies, varying in duration from one night to 28 days, were conducted. Overall, the studies demonstrated Sonata 10 mg and 20 mg as superior over placebo in reducing latency to persistent sleep (LPS) on the first 2 nights of treatment. A reduction in LPS relative to baseline was observed for all treatment groups at later time points. As a result, a significant difference from placebo was not observed beyond 2 nights. Trials focusing on elderly patients were conducted, but no significant difference in effect was observed between elderly patients and other adult patients.
What the Patient Should Know
The most common adverse events were headache, drowsiness, and dizziness. There was no evidence of memory or psychomotor impairment four or more hours after administration of Sonata. Until the patient is aware of whether or not he/she will experience carryover effects, extreme caution should be taken when completing tasks that require complete alertness. Alcohol should not be consumed while taking Sonata, as it increases the side effects of the drug. The recommended dose is 5 mg for elderly patients and 10 mg for younger adults.