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

Annemiek Vermeeren, Hong Sun, Eric F P M Vuurman, Stefan Jongen, Cees J Van Leeuwen, Anita C M Van Oers, John Palcza, Xiadong Li, Tine Laethem, Ingeborg Heirman, An Bautmans, Matthew D Troyer, Rebecca Wrishko, Jacqueline McCrea

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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.
Original languageEnglish
Pages (from-to)1803-1813
Number of pages12
JournalSleep
Volume38
Issue number11
DOIs
Publication statusPublished - 1 Nov 2015

Keywords

  • 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
  • MEMORY
  • hypnotics
  • PLACEBO
  • zopiclone
  • ZOPICLONE 7.5 MG
  • plasma concentrations
  • driving
  • OREXIN RECEPTOR ANTAGONIST
  • orexin antagonist

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