On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg:A Study in Non-Elderly Healthy Volunteers

Study Objective: To evaluate next-morning driving performance in adults younger than 65 years, after single and repeated doses of suvorexant 20 and 40 mg. Design: Double-blind, placebo-controlled, 4-period crossover study. Setting: Maastricht University, The Netherlands. Participants: 28 healthy volunteers (15 females), aged 23 to 64 years. Interventions: Suvorexant (20 and 40 mg) for 8 consecutive nights; zopiclone 7.5 mg nightly on day 1 and 8; placebo. Measurements: Performance on day 2 and 9 (9 h after dosing) using a one-hour standardized highway driving test in normal traffic, measuring... Mehr ...

Verfasser: Vermeeren, Annemiek
Sun, Hong
Vuurman, Eric F P M
Jongen, Stefan
Van Leeuwen, Cees J
Van Oers, Anita C M
Palcza, John
Li, Xiadong
Laethem, Tine
Heirman, Ingeborg
Bautmans, An
Troyer, Matthew D
Wrishko, Rebecca
McCrea, Jacqueline
Dokumenttyp: Artikel
Erscheinungsdatum: 2015
Reihe/Periodikum: Vermeeren , A , Sun , H , Vuurman , E F P M , Jongen , S , Van Leeuwen , C J , Van Oers , A C M , Palcza , J , Li , X , Laethem , T , Heirman , I , Bautmans , A , Troyer , M D , Wrishko , R & McCrea , J 2015 , ' On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg : A Study in Non-Elderly Healthy Volunteers ' , Sleep , vol. 38 , no. 11 , pp. 1803-1813 . https://doi.org/10.5665/sleep.5168
Schlagwörter: Adult / Automobile Driving / Azabicyclo Compounds / Azepines / Cross-Over Studies / Double-Blind Method / Female / Healthy Volunteers / Humans / Individuality / Male / Middle Aged / Netherlands / Piperazines / Psychomotor Performance / Self Report / Sleep Aids / Pharmaceutical / Sleep Stages / Triazoles / Young Adult / SLEEP / memory / INSOMNIA PATIENTS / suvorexant / IMPAIRMENT / DSST / HYPNOTICS / ZOLPIDEM / balance / ALCOHOL / PLACEBO / zopiclone / ZOPICLONE 7.5 MG / plasma concentrations / driving / OREXIN RECEPTOR ANTAGONIST / orexin antagonist
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29187464
Datenquelle: BASE; Originalkatalog
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Link(s) : https://cris.maastrichtuniversity.nl/en/publications/b4ef6277-42be-40ab-9cfa-bf74d3c6a56d

Study Objective: To evaluate next-morning driving performance in adults younger than 65 years, after single and repeated doses of suvorexant 20 and 40 mg. Design: Double-blind, placebo-controlled, 4-period crossover study. Setting: Maastricht University, The Netherlands. Participants: 28 healthy volunteers (15 females), aged 23 to 64 years. Interventions: Suvorexant (20 and 40 mg) for 8 consecutive nights; zopiclone 7.5 mg nightly on day 1 and 8; placebo. Measurements: Performance on day 2 and 9 (9 h after dosing) using a one-hour standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug-placebo changes in SDLP > 2.4 cm were considered to reflect meaningful driving impairment. Results: Mean drug-placebo changes in SDLP following suvorexant 20 and 40 mg were 1.01 and 1.66 cm on day 2, and 0.48 and 1.31 cm on Day 9, respectively. The 90% CIs of these changes were all below 2.4 cm. Symmetry analysis showed that more subjects had SDLP changes > 2.4 cm than < -2.4 cm following suvorexant 20 and 40 mg on day 2, and following suvorexant 40 mg on day 9. Four female subjects requested that a total of 5 driving tests-all following suvorexant-stop prematurely due to self-reported somnolence. Conclusions: As assessed by mean changes in standard deviation of lateral position (SDLP), there was no clinically meaningful residual effect of suvorexant in doses of 20 and 40 mg on next-morning driving (9 h after bedtime dosing) in healthy subjects < 65 years old. There may be some individuals who experience next-day effects, as suggested by individual changes in SDLP and prematurely stopped tests.