Zaleplon comparative studies

Three doses of zaleplon have been compared with placebo in outpatients with insomnia in a 4-week study (11). During week 1, sleep latency was significantly shorter with zaleplon 5, 10, and 20 mg than with placebo. The significant reduction in sleep latency persisted to week 3 with zaleplon 10 mg and to week 4 with zaleplon 20 mg. Compared with placebo, zaleplon 10 mg and 20 mg also had significant positive effects on sleep duration, number of awakenings, and sleep quality. Pharmacological tolerance did not develop with zaleplon and there were no indications of rebound insomnia or withdrawal symptoms after discontinuation. There was no significant difference in the frequency of adverse events with zaleplon compared with placebo. The authors concluded that zaleplon provides effective treatment of insomnia with a favorable safety profile. 

In a controlled study in healthy patients with a history of drug abuse, zaleplon was shown to have a comparable abuse potential to that of the benzodiazepine, triazolam [28]. 

Zaleplon and triazolam have been compared in two concurrent multicenter, randomized, double-blind, placebo-controlled crossover studies in chronic insomniacs (12). Study 1 compared zaleplon (10 and 40 mg) with triazolam (0.25 mg) and placebo study 2 compared zaleplon (20 and 60 mg) with triazolam (0.25 mg) and placebo. All doses of zaleplon produced significant reductions in... 

Zaleplon and zolpidem have been compared in two concurrent multicenter, randomized, double-blind, placebo-controlled crossover studies in chronic insomniacs (12). In study 1, zaleplon 10 mg, zolpidem 10 mg, or placebo were given double-bhnd to 36 healthy subjects under standardized conditions in a six-period, incomplete-block, crossover study (13). The subjects were gently awakened and given the medication at predetermined times, 5, 4, 3, or 2 hours before morning awakening, which occurred 8 hours after bedtime. When they awoke in the morning, subjective and objective assessments of residual effects of hypnotics were administered. There were no serious adverse experiences during the study all adverse events were mild to moderate. The most commonly reported adverse events associated with zaleplon were weakness and somnolence. Weakness, depersonalization, dizziness, and somnolence were the most frequent nervous system adverse events associated with zolpidem. 

The effects of alcohol combined with either zaleplon or triazolam have been studied in 18 healthy volunteers (21). Triazolam, with and without ethanol, impaired digit symbol substitution, symbol copying, simple and complex reaction times, and divided attention performance compared with placebo. Zaleplon without ethanol impaired only digit symbol substitution and divided attention tracking, but when it was combined with ethanol all measures were impaired. However, zaleplon without ethanol was consistently better than triazolam alone. Zaleplon produced less performance impairment and a shorter period of ethanol potentiation than triazolam. 

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