title: Effects of armodafinil on simulated driving and alertness in shift work disorder.
abstract: OBJECTIVE
  Forty-one percent of shift workers report dozing while driving. This study tested whether armodafinil improves driving simulator performance in subjects with shift work disorder (SWD). A primary outcome was performance late in the shift when workers are typically driving home.
  
  
  METHODS
  Randomized, double-blind, crossover. During each 12-h test session (21:30-09:30), subjects were kept awake except for multiple sleep latency testing (MSLT: 01:30, 03:30, 05:30, and 07:30). Subjective sleepiness (Karolinska Sleepiness Scale, KSS), driving performance, and cognitive performance (digit symbol substitution test and creativity on the Remote Associates Test, RAT) were evaluated during the night shift and commute home times.
  
  
  METHODS
  Hospital-based sleep research laboratory.
  
  
  METHODS
  Twenty night workers (age: 42.7 ± 8.7 y, 17 F) with excessive sleepiness (≥ 10 on the Epworth Sleepiness Scale), meeting International Classification of Sleep Disorders, Second Edition (ICSD-2) criteria for SWD, and having no other medical conditions.
  
  
  METHODS
  Armodafinil (150 mg) or placebo at (23:45 h) on counterbalanced nights separated by 7-14 days.
  
  
  RESULTS
  Primary endpoints were driving simulator performance (standard deviation of lateral position (SDLP) and off-road deviations) with four sessions starting 3.25 h after drug administration, objective sleepiness (MSLT; 1.75 to 7.75 h post-drug), and creativity (5 h post-drug). Significant effects of drug were observed for each driving measure (P < 0.05). Armodafinil significantly improved SDLP for simulator sessions at 05:30, 07:30, and 09:30, and off-road deviations at 7 h, 15 min and 9 h, 15 min post-drug (P < 0.05). Armodafinil also improved objective sleepiness from 3.7 ± 0.6 min to 9.7 ± 5.2 min (P < 0.001) and RAT score from 8.75 ± 4.9 to 11.25 ± 6.0 (P < 0.005).
  
  
  CONCLUSIONS
  Armodafinil 150 mg early in the night shift improves driving simulator performance in SWD. Effects on sleepiness, cognition, and driving were found up to 9.5 h post-ingestion, during the critical time when many night workers are driving home.
authors.affiliation: Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI.
authors.forename: Christopher
authors.initials: C
authors.lastname: Drake
authors.affiliation: Magnetoencephalography Laboratory, Meadowlands Hospital, Secaucus, NJ.
authors.forename: Valentina
authors.initials: V
authors.lastname: Gumenyuk
authors.affiliation: Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
authors.affiliation: Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI.
authors.forename: Ryan
authors.initials: R
authors.lastname: Howard
mesh_terms: D000328:Adult; D001288:Attention / Q000187:drug effects* / Q000502:physiology; D001334:Automobile Driving / Q000523:psychology*; D001559:Benzhydryl Compounds / Q000494:pharmacology* / Q000627:therapeutic use; D003071:Cognition / Q000187:drug effects / Q000502:physiology; D003405:Creativity; D018592:Cross-Over Studies; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009048:Motor Skills / Q000187:drug effects* / Q000502:physiology; D020178:Sleep Disorders, Circadian Rhythm / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D012894:Sleep Stages / Q000187:drug effects / Q000502:physiology; D014851:Wakefulness / Q000187:drug effects / Q000502:physiology; D064690:Wakefulness-Promoting Agents / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil
keywords: alertness; armodafinil; creativity; driving; shift work disorder