TY - JOUR PY - 2022// TI - Residual effects of zopiclone on driving performance using a standardized driving simulator among healthy volunteers JO - Psychopharmacology A1 - Iwamoto, Kunihiro A1 - Iwata, Mari A1 - Kambe, Daiji A1 - Imadera, Yumiko A1 - Tachibana, Naoki A1 - Kajiyama, Yu A1 - Ando, Masahiko A1 - Ozaki, Norio SP - ePub EP - ePub VL - ePub IS - ePub N2 - 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

LA - en SN - 0033-3158 UR - http://dx.doi.org/10.1007/s00213-022-06075-y ID - ref1 ER -