A Study Comparing the Hypnotic Efficacies and Residual Effects on Actual Driving Performance of Midazolam 15 mg, Triazolam 0.5 mg, Temazepam 20 mg and Placebo in Shiftworkers on Night Duty

Riedel, W. J.; Quasten, R.; Hausen, C.; O'Hanlon, J. F. · 1988 · ROSA P / Rijksuniversiteit Limburg. Institute for Drugs, Safety and Behavior

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Summary

This study investigated the hypnotic efficacy and residual effects on driving performance of three benzodiazepine hypnotics—midazolam (15 mg), triazolam (0.5 mg), and temazepam (20 mg)—compared to placebo in rotating shift workers suffering from transient insomnia. The research was motivated by the need to determine if short-acting hypnotics could improve day-sleep without causing residual sedation that would impair safety during subsequent work or commuting. The study focused on workers with an average day-sleep duration of 5 to 6 hours, aiming to assess whether these drugs could extend sleep and improve quality while remaining safe for driving 6.5 to 8.5 hours post-administration. The study employed a double-blind, balanced cross-over design involving 14 rotating shift workers (12 men, 2 women) who met criteria for sleep disturbance after night duty. Participants received one of the four treatments over five consecutive days. Sleep was monitored using wrist-worn activity meters in the laboratory on days 1 and 5, and at home on intermediate days. Driving performance was assessed on days 1 and 5, approximately 6.5 to 8.5 hours after drug ingestion. The assessment included a city driving test, where an expert rated driving behavior and eye movements were recorded, and a highway driving test, which continuously measured lateral position, speed, steering angle error, and time to line crossing. Subjective sleep quality, arousal, and mood were also recorded via questionnaires. The results indicated distinct differences among the drugs. Midazolam significantly prolonged day-sleep duration at home and improved subjective sleep quality relative to placebo, with minimal residual effects on driving; impairment was observed only to a limited extent during highway driving on the fifth day of treatment. Triazolam decreased activity during sleep, suggesting increased sleep depth, but it greatly impaired driving performance in both city and highway tests. Temazepam showed no significant influence on sleep parameters and had no effect on driving performance. Subjectively, all three drugs improved activation during night duty compared to placebo, though triazolam’s effect was lesser. The study concluded that midazolam 15 mg is recommended for rotating shift workers to cope with transient insomnia, as it improves sleep with negligible residual effects 6.5 hours after ingestion. Temazepam 20 mg was found to be free from residual sedative effects but was less likely to improve day-sleep. Triazolam 0.5 mg was not recommended due to its significant impairment of driving performance 6.5 to 8.5 hours after ingestion, despite its efficacy in reducing sleep activity. These findings highlight the importance of selecting hypnotics based on both sleep efficacy and safety profiles for shift workers.

Key finding

Triazolam 0.5 mg significantly impaired driving performance in both city and highway tests, whereas midazolam 15 mg improved sleep without substantial residual impairment, and temazepam 20 mg had no significant effects on sleep or driving.

Methodology

field_study

Sample size: 14

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