Acute and Carry‐Over Effects of Brotizolam Compared to Nitrazepam and Placebo in Monotonous Simulated Driving

Törnros, Jan; Laurell, Hans · 1990 · Crossref

DOI: 10.1111/j.1600-0773.1990.tb00786.x

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Summary

This study investigates the acute and residual (carry-over) effects of the short-acting hypnotic brotizolam (0.25 mg) compared to the long-acting hypnotic nitrazepam (5 mg) and placebo on simulated driving performance. The research was motivated by the hypothesis that benzodiazepines with longer elimination half-lives, such as nitrazepam (21–28 hours), cause greater unwanted residual effects the following morning than those with shorter half-lives, like brotizolam (approximately 5 hours). Previous studies had indicated residual effects from nitrazepam on driving performance, whereas no such effects were found for triazolam. The study employed a double-blind, randomized, repeated-measures design involving eighteen healthy volunteers aged 20–35 with valid driving licenses. Participants took medication orally for three consecutive nights. Twelve subjects participated in both acute and residual effect assessments, while six participated only in the residual effects phase. Acute effects were measured immediately after drug intake on the first night, while residual effects were assessed the following morning after three nights of medication. The primary performance measures were brake reaction time (BRT) to auditory stimuli and time spent outside the road lane during a 2-hour 20-minute monotonous simulated driving task. Self-rated alertness was also recorded using the Activation-Deactivation Adjective Checklist. Regarding acute effects, both active drugs significantly prolonged brake reaction times compared to placebo, with no significant difference between brotizolam and nitrazepam. However, a significant drug-by-time-on-task interaction indicated that performance decrement over time was greater in the active drug conditions. Nitrazepam tended to show the greatest impairment across all measures, including higher time outside the road and lower self-rated arousal, though these differences were not statistically significant. For residual effects, no statistically significant differences were found between treatments for brake reaction time or self-rated alertness. Nitrazepam again tended to score worst on reaction time and alertness, while placebo scored best. Time outside the road could not be statistically analyzed due to the low number of incidents. The study concludes that while acute impairment is evident for both hypnotics, residual effects on simulated driving performance after three nights of use are of small magnitude and not statistically significant for either drug. The results support the pharmacokinetic expectation that short-acting hypnotics like brotizolam do not produce significant residual driving impairment the following morning. The findings align with previous laboratory studies showing no detrimental residual effects for brotizolam, whereas the status of nitrazepam’s residual effects remains less consistent across different study designs.

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• Empirical Findings: behavioral performance data