OBJECTIVE: To assess the residual effects of lormetazepam on daytime vigilance, psychomotor performance and simulated driving in adult healthy volunteers. MATERIAL: Twelve subjects (7 women, 5 men), aged 27 - 38 years (mean 31). METHOD: Subjects received lormetazepam 1 mg tablet and placebo for 3 days at nighttime in a randomized, double-blind, crossover design, with a 1-week interval between medications. On the morning following the last drug administration, the subjects completed a 15-min battery of neuropsychological tests aimed at assessing memory and attention, performed simple and choice visual reaction times, and self-rated their own level of sleepiness using the Epworth sleepiness scale. Afterwards, an interactive, computer-based driving simulator (STISIM) was used to assess the effect of the study drugs on driving ability, followed by the multiple sleep latency test (MSLT). RESULTS: The findings showed that participants had similar performance when treated with lormetazepam and placebo. Indeed, as compared with baseline, neuropsychological tests, visual reaction times, sleep latency using the MSLT and driving ability showed no deterioration following either placebo or active medication. CONCLUSIONS: The data suggest that 3-day use of lormetazepam 1 mg/day neither influences daytime vigilance nor impairs psychomotor task performance and simulated driving. Results confirm previous evidence that the intermediate-acting hypnotic benzodiazepine lormetazepam is devoid of residual effects in respect to psychomotor ability. However, caution should be exercised in the interpretation of the results due to the limited sensitivity of the study.
RCT Entities:
OBJECTIVE: To assess the residual effects of lormetazepam on daytime vigilance, psychomotor performance and simulated driving in adult healthy volunteers. MATERIAL: Twelve subjects (7 women, 5 men), aged 27 - 38 years (mean 31). METHOD: Subjects received lormetazepam 1 mg tablet and placebo for 3 days at nighttime in a randomized, double-blind, crossover design, with a 1-week interval between medications. On the morning following the last drug administration, the subjects completed a 15-min battery of neuropsychological tests aimed at assessing memory and attention, performed simple and choice visual reaction times, and self-rated their own level of sleepiness using the Epworth sleepiness scale. Afterwards, an interactive, computer-based driving simulator (STISIM) was used to assess the effect of the study drugs on driving ability, followed by the multiple sleep latency test (MSLT). RESULTS: The findings showed that participants had similar performance when treated with lormetazepam and placebo. Indeed, as compared with baseline, neuropsychological tests, visual reaction times, sleep latency using the MSLT and driving ability showed no deterioration following either placebo or active medication. CONCLUSIONS: The data suggest that 3-day use of lormetazepam 1 mg/day neither influences daytime vigilance nor impairs psychomotor task performance and simulated driving. Results confirm previous evidence that the intermediate-acting hypnotic benzodiazepine lormetazepam is devoid of residual effects in respect to psychomotor ability. However, caution should be exercised in the interpretation of the results due to the limited sensitivity of the study.