Ambien Clinical Trials and Studies
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Ambien Clinical Trials and Studies
Controlled Trials Supporting Ambien Safety And Efficacy
Transient Insomnia
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 Ambien (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.
Chronic Insomnia
Adult outpatients, with chronic insomnia (n=75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of Ambien (10 and 15 mg) and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 15 mg was superior to placebo for all 5 weeks; Ambien 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Ambien was comparable to placebo on number of awakenings at both doses studied.
Adult outpatients (n=141) with chronic insomnia were evaluated in a double-blind, parallel group, 4-week trial comparing two doses of Ambien (zolpidem) (10 and 15 mg) and placebo. Ambien (Zolpidem) 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Ambien (Zolpidem) 15 mg was superior to placebo on a subjective measure of sleep latency for the first 3 weeks, on a subjective measure of total sleep time for the first week, and on number of awakenings and sleep quality for the first 2 weeks.
Next-day Residual Effects
There was no evidence of residual next-day effects seen with Ambien (zolpidem tartrate) in several studies utilizing the Multiple Sleep latency Test (MSLT), the Digit Symbol Substitution Test (DSST), and patient ratings of alertness. In one study involving elderly patients, there was a small but statistically significant decrease in one measure of performance, the DSST, but no impairment was seen in the MSLT study.
Rebound Effects
There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Ambien. There was subjective evidence of impaired sleep in the elderly on the first posttreatment night at doses above the recommended elderly dose of 5 mg.
Memory Impairment
Two small studies (n=6 and n=9) utilizing objective measures of memory yielded little evidence for memory impairment following the administration of Ambien (zolpidem tartrate). There was subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration Ambien (zolpidem tartrate), predominantly at doses above 10 mg.
Effects on sleep stages
In studies that measured the percentage of sleep time spent in each sleep stage, Ambien (zolpidem tartrate) has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.
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