Short-term safety profile of zolpidem: objective measures of cognitive effects.

The potential effects of zolpidem, a non-benzodiazepine hypnotic, on cognitive and psychomotor functions have been explored in more than 30 placebo controlled studies, and in many cases in comparison with benzodiazepine reference hypnotics (ie flunitrazepam, nitrazepam, triazolam). Daytime impact of drug administration on alertness has been studied with the Multiple Sleep Latency Test, and no significant clinical impairment has been found after zolpidem 5 to 10 mg, unlike benzodiazepines. Evaluation of the effects of zolpidem on attention and psychomotor skills (critical flicker fusion threshold, substitution or copying tests, choice reaction times or driving tests, etc) indicate that zolpidem at recommended doses (5 mg in elderly and 10 mg in adults) is unlikely to produce significant detrimental residual effects on daytime vigilance, concentration and coordination performances on the morning after intake. In accordance with its pharmacokinetic and pharmacodynamic properties, the effects on zolpidem on memory functions were limited to the first hours after administration and no significant difference was observed between zolpidem (5-10 mg) and placebo 6 hours after administration; longer memory impairment was observed with flunitrazepam or triazolam. Various groups of subjects were included in these studies, both young adults and elderly subjects, healthy volunteers and insomniac patients, and duration of treatment varied between one single dose and 28 days of repeated intake. In conclusion, experimental evidence demonstrates a satisfactory safety profile of zolpidem (5-10 mg) on daytime cognitive functions as compared to other hypnotics.

RCT Entities:   Population Interventions Outcomes