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Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator.

ABSTRACT: Use of hypnotics is often associated with next-morning residual effects and a higher risk of motor vehicle accidents. Measuring next-morning effects on driving performance is therefore advised by regulatory agencies. Here, we examined driving performance following administration of daridorexant, a new dual orexin receptor antagonist developed to treat insomnia. Sixty healthy male and female subjects (50-79 years of age) were randomized in a placebo- and active-controlled, four-way cross-over study. Each subject received evening administration of daridorexant 50 and 100 mg, zopiclone 7.5 mg, and placebo, in separate treatment phases of 4 days. Simulated driving performance was assessed after initial (day 2) and repeated dosing (day 5), 9 hours postdose. Standard deviation of the lateral position (SDLP) was the main outcome. On both days, with zopiclone, SDLP increased significantly compared with placebo, which confirmed sensitivity of the simulator. With daridorexant, on day 2, the placebo-corrected mean (97.5% confidence interval) SDLP increased by 2.19 cm (0.46-3.93) and 4.43 cm (2.72-6.15) for 50 and 100 mg, respectively. On day 5, SDLP values for both daridorexant doses were significantly below the prespecified threshold of impairment (2.6 cm) and statistically not different from placebo. Daridorexant showed a lower self-rated driving quality and higher effort compared to placebo on day 2 but not on day 5. In non-insomnia subjects, daridorexant impaired simulated driving after initial but not after repeated dosing. Subjects should be cautioned about driving until they know how daridorexant affects them.

SUBMITTER: Muehlan C

PROVIDER: S-EPMC9320895 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Objectives: Attention Restoration Theory (ART) suggests that walking or being in natural settings, as opposed to urban environments, benefits cognitive skills because it is less demanding on attentional resources. However, it is unclear whether the same occurs when the person is performing a complex task such as driving, although it is proven that driving through different road environments is associated with different levels of fatigue and may engage attention differently. The present study investigated whether exposure to rural vs. urban road environments while driving would affect attentional capacity in young people after the drive, in line with the classic ART paradigms. Methods: We asked 38 young participants to complete the Sustained Attention to Response Task (SART) before and after being exposed to a rural or urban road in a virtual reality environment while driving in a full vehicle immersive driving simulator. Changes in SART performance based on environmental exposure where explored in terms of target sensitivity, accuracy, reaction times, and inverse efficiency. We analyzed potential road type effects on driving speed and accuracy. Possible effects of driving on attention were tested by comparing the sample performance to that of a control group of 15 participants who did not drive and sat on the passenger seat instead. Results: Exposure to rural or urban road environments in the driving sample was not associated with any significant changes in attentional performance. The two exposure groups did not differ significantly in terms of driving behavior. Comparisons between the driving sample and the control group controlling for age indicated that participants who drove were more accurate but slower at the SART than those who were passengers. Conclusion: The present study does not support the hypothesis that a short drive in a natural setting may promote attention restoration as compared to an urban setting. Methodological considerations as well as recommendations for future research are discussed.

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Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator.

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