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Journal Article

Citation

Iwamoto K, Iwata M, Kambe D, Imadera Y, Tachibana N, Kajiyama Y, Ando M, Ozaki N. Psychopharmacology 2022; ePub(ePub): ePub.

Copyright

(Copyright © 2022, Holtzbrinck Springer Nature Publishing Group)

DOI

10.1007/s00213-022-06075-y

PMID

35106620

Abstract

RATIONALE: The effects of hypnotics on automobile driving have been attracting increasing attention. However, few driving simulators (DSs) have been confirmed to have acceptable reliability and validity for assessing the next-day residual effects of zopiclone as a positive control on driving performance.

OBJECTIVE: To investigate whether a new DS could permit detection of the next-day residual effects of zopiclone on driving performance.

METHODS: In this double-blind, randomized, placebo-controlled crossover trial, 28 healthy males received zopiclone 7.5 mg at bedtime on days 1 and 8 and placebo on the other days over a period of 16 days. The participants took part in three driving tasks-road-tracking, car-following, and harsh-braking-using a DS on days 2 and 9 at 9-h post-dosing. Scores on the Karolinska Sleepiness Scale and Profile of Mood States-Second Edition were then assessed, as was the serum concentration of zopiclone.

RESULTS: The estimated differences in the standard deviation of lateral position (cm) in the road-tracking task between the zopiclone and placebo groups on days 2 and 9 were 3.75 cm (90% confidence interval (CI): 1.71-5.79) and 4.07 cm (90% CI: 2.02-6.11), respectively. The estimated differences in the distance coefficient of variation in the car-following task and in the brake reaction time in the harsh-braking task between the zopiclone and placebo groups on day 2 were 4.31 (90% CI: 1.94-6.69) and 24.6 ms (90% CI: 12.7-36.4), respectively.

CONCLUSIONS: The DS used in this study has sufficient sensitivity to detect the next-day residual effects of zopiclone on driving performance.


Language: en

Keywords

Driving simulator; Driving performance; Kunihiro Iwamoto and Mari Iwata joint first authorship and contributed equally to this paper; Positive control; SDLP; Sensitivity; Zopiclone

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