title: On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers.
abstract: OBJECTIVE
  To evaluate next-morning driving performance in adults younger than 65 years, after single and repeated doses of suvorexant 20 and 40 mg.
  
  
  METHODS
  Double-blind, placebo-controlled, 4-period crossover study.
  
  
  METHODS
  Maastricht University, The Netherlands.
  
  
  METHODS
  28 healthy volunteers (15 females), aged 23 to 64 years.
  
  
  METHODS
  Suvorexant (20 and 40 mg) for 8 consecutive nights; zopiclone 7.5 mg nightly on day 1 and 8; placebo.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov NCT01311882.
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Annemiek
authors.initials: A
authors.lastname: Vermeeren
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Hong
authors.initials: H
authors.lastname: Sun
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Eric F P M
authors.initials: EF
authors.lastname: Vuurman
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Stefan
authors.initials: S
authors.lastname: Jongen
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Cees J
authors.initials: CJ
authors.lastname: Van Leeuwen
authors.affiliation: Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
authors.forename: Anita C M
authors.initials: AC
authors.lastname: Van Oers
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: John
authors.initials: J
authors.lastname: Palcza
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Xiadong
authors.initials: X
authors.lastname: Li
authors.affiliation: MSD Belgium, Brussels, Belgium.
authors.forename: Tine
authors.initials: T
authors.lastname: Laethem
authors.affiliation: MSD Belgium, Brussels, Belgium.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Heirman
authors.affiliation: MSD Belgium, Brussels, Belgium.
authors.forename: An
authors.initials: A
authors.lastname: Bautmans
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Troyer
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Wrishko
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: McCrea
mesh_terms: D000328:Adult; D001334:Automobile Driving / Q000523:psychology*; D053961:Azabicyclo Compounds / Q000008:administration & dosage / Q000494:pharmacology; D001381:Azepines / Q000008:administration & dosage* / Q000494:pharmacology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007206:Individuality; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010879:Piperazines / Q000008:administration & dosage / Q000494:pharmacology; D011597:Psychomotor Performance / Q000187:drug effects; D057566:Self Report; D000068776:Sleep Aids, Pharmaceutical / Q000008:administration & dosage* / Q000494:pharmacology*; D012894:Sleep Stages / Q000187:drug effects / Q000502:physiology; D014230:Triazoles / Q000008:administration & dosage* / Q000494:pharmacology*; D055815:Young Adult
chemical_list: D053961:Azabicyclo Compounds; D001381:Azepines; D010879:Piperazines; D000068776:Sleep Aids, Pharmaceutical; D014230:Triazoles; C515050:zopiclone; C551624:suvorexant
keywords: DSST; balance; driving; hypnotics; memory; orexin antagonist; plasma concentrations; suvorexant; zopiclone