Zaleplon Sonata Medicine - Information, Side effects and uses of Zaleplon

Brand name: Sonata

Zaleplon is indicated for the short-term treatment of insomnia.

Zaleplon decreases the time to sleep onset but has not been shown to increase total sleep time or decrease number of awakenings. Failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric or medical illness. Worsening of insomnia or the emergence of new abnormalities of thinking or behavior may be a consequence of an unrecognized psychiatric or physical disorder.

Zaleplon interacts with the gamma-aminobutyric acid type A-benzodiazepine (GABA-BZ) receptor complex. Modulation of the GABA-BZ receptor chloride channel macromolecular complex appears to be responsible for the pharmacological properties of the benzodiazepines including sedative, anxiolytic, muscle relaxant, and anticonvulsant effects. Zaleplon binds selectively to the brain alpha subunit of the GABAA omega-1 receptor.

Precaution and Warning while taking Zaleplon

• When testing for chromosomal aberrations, in the in vitro Chinese hamster ovary cell assay, zaleplon was clastogenic in both the presence and absence of metabolic activation, causing structural and numerical aberrations. 1 In the in vitro human lymphocyte assay, zaleplon was clastogenic causing numerical but not structural aberrations.
• Pregnancy - Zaleplon has not been studied in pregnant women.
• A small amount of zaleplon is distributed into breast milk. The effect of zaleplon on the infant is unknown.
• Appropriate studies on the relationship of age to the effects of zaleplon have not been performed in the pediatric population. Safety and efficacy have not been established.
• In studies performed on 628 elderly patients, sleep latency improved with a reduced dose of 5 mg. The incidence of adverse events with a frequency of at least 1% was not significantly different between placebo and zaleplon at doses of either 5 mg or 10 mg during studies of a 14 day duration. The pharmacokinetics of zaleplon in the elderly, age 65 to 85 years, are not significantly different from those in younger patients. However, elderly patients appear to be more sensitive to the effects of hypnotics.
• In mice receiving doses of 25, 50, 100, and 200 mg per kg of body weight (mg/kg) a day (6 to 49 times the maximum recommended human dose [MRHD] on a mg per square meter of body surface area [mg/m2] basis), there was a significant increase in the incidence of hepatocellular adenomas in females receiving the highest dose. No evidence of carcinogenic potential was seen in rats receiving 1, 10, and 20 mg/kg a day (0.5 to 10 times the MRHD on a mg/m 2 basis).

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