EFFECT OF ZOLPIDEM ON SLEEP IN HEALTHY-SUBJECTS - A PLACEBO-CONTROLLED TRIAL WITH POLYSOMNOGRAPHIC RECORDINGS

The aims of this double-blind, placebo-controlled study, conducted in a group of healthy young adults with normal sleep patterns, were to as certain the effect of various doses of zolpidem on polysomnographic va riables and to determine whether zolpidem disrupts sleep architecture. Of the 15 subjects recruited, 8 were included in the final analysis. Subjects underwent four experimental sessions during three nights, of which the first night was used for adaptation, the second for zolpidem (10, 20, and 40 mg) or placebo administration, and the third for plac ebo administration. Sleep was assessed by conventional sleep parameter s (latency, duration, wakefulness) and by subjective questionnaire. Po lysomnographic recordings were analyzed for sleep stage, paradoxical s leep, graphic features, and longitudinally with reference to sleep sta ge. Zolpidem had little effect on polysomnographic variables, except f or a trend toward a hypnotic effect and a slight, transient inhibition of paradoxical sleep at the highest dose. In particular, the clearcut reduction of stage 4 sleep and increase in spindle density often obse rved with benzodiazepine administration was not observed with zolpidem . Adverse effects were restricted to three reports of daytime drowsine ss each after zolpidem 10 and 40 mg and placebo, and one amnesic episo de after the highest dose (40 mg). There were no signs of ataxic sympt omatology.