title: Next-day residual effects of gabapentin, diphenhydramine, and triazolam on simulated driving performance in healthy volunteers: a phase 3, randomized, double-blind, placebo-controlled, crossover trial.
abstract: Next-day residual effects of a nighttime dose of gabapentin 250 mg were evaluated on simulated driving performance in healthy participants in a randomized, placebo-controlled, double-blind, multicenter, four-period crossover study that included diphenhydramine citrate 76 mg and triazolam 0.5 mg.
  
  
  
  At treatment visits, participants (n = 59) were dosed at ~23:30, went to bed immediately, and awakened 6.5 h postdose for evaluation. The primary endpoint was the standard deviation of lateral position for the 100-km driving scenario. Additional measures of driving, sleepiness, and cognition were included.
  
  
  
  Study sensitivity was established with triazolam, which demonstrated significant next-day impairment on all driving endpoints, relative to placebo (p < 0.001). Gabapentin demonstrated noninferiority to placebo on standard deviation of lateral position and speed deviation but not for lane excursions. Diphenhydramine citrate demonstrated significant impairment relative to gabapentin and placebo on speed deviation (p < 0.05). Other comparisons were either nonsignificant or statistically ineligible per planned, sequential comparisons. Secondary endpoints for sleepiness and cognitive performance were supportive of these conclusions.
  
  
  
  Together, these data suggest that low-dose gabapentin had no appreciable next-day effects on simulated driving performance or cognitive functioning. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Cognitive Research Corporation, St. Petersburg, Florida, USA.
authors.forename: Gary G
authors.initials: GG
authors.lastname: Kay
authors.affiliation: Miami Research Associates, South Miami, Florida, USA.
authors.forename: Howard I
authors.initials: HI
authors.lastname: Schwartz
authors.affiliation: Pfizer Consumer Healthcare, Madison, New Jersey, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Wingertzahn
authors.affiliation: Pfizer Consumer Healthcare, Madison, New Jersey, USA.
authors.forename: Shyamalie
authors.initials: S
authors.lastname: Jayawardena
authors.affiliation: Neurotrials Research Inc., Atlanta, Georgia, USA.
authors.forename: Russell P
authors.initials: RP
authors.lastname: Rosenberg
mesh_terms: D000328:Adult; D000588:Amines / Q000008:administration & dosage / Q000009:adverse effects*; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects; D001334:Automobile Driving; D003071:Cognition / Q000187:drug effects; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects*; D004155:Diphenhydramine / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012894:Sleep Stages / Q000187:drug effects; D013997:Time Factors; D014229:Triazolam / Q000008:administration & dosage / Q000009:adverse effects*; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000588:Amines; D000700:Analgesics; D014151:Anti-Anxiety Agents; D003509:Cyclohexanecarboxylic Acids; D006993:Hypnotics and Sedatives; D014229:Triazolam; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D004155:Diphenhydramine
keywords: diphenhydramine; gabapentin; residual effects; simulated driving performance; sleep