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 language | English |
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Pages (from-to) | 1803-1813 |
Number of pages | 12 |
Journal | Sleep |
Volume | 38 |
Issue number | 11 |
DOIs | |
Publication status | Published - 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