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In contrast, if half-lives, including half-lives of active metabolites, are short, drug and metabolites will be cleared before the next dose is ingested, and carryover effects related to excessive sedation or CNS depression should be minimal or absent. Ambien has a short half-life and no active metabolites. During nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug or its active metabolites (ie, in relationship to the receptor site) may occur at some point in the interval between each night’s use. This sequence of events may account for two clinical findings reported to occur after several weeks of nightly use of other rapidly eliminated hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety. Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Ambien. Controlled trials supporting safety and efficacy Transient insomnia: Text Continues Below
Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings. Normal elderly adults (mean age 68) experiencing transient insomnia (n=35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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