title: A randomized, double-blind, placebo-controlled, multicenter, 28-day, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
abstract: To evaluate multiple doses of gabapentin 250 mg on polysomnography (PSG) and participant-reported sleep assessments in a 5-h phase advance insomnia model.
  
  
  
  Adults reporting occasional disturbed sleep received gabapentin 250 mg (n = 128) or placebo (n = 128). On Days 1 and 28, participants received medication 30 min before bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, a post sleep questionnaire, and the Karolinska Sleep Diary. Next-day residual effects and tolerability were evaluated. On Days 2-27, participants took medication at home 30 min before their habitual bedtime.
  
  
  
  Treatment-group demographics were comparable. Gabapentin resulted in significantly less PSG wake after sleep onset (WASO) compared with placebo on Day 1 (primary endpoint, mean: 107.0 versus 149.1 min, p ≤ 0.001) and Day 28 (113.6 versus 152.3 min, p = 0.002), and significantly greater total sleep time (TST; Day 1: 347.6 versus 283.9 min; Day 28: 335.3 versus 289.1 min) (p ≤ 0.001). Participant-reported WASO and TST also showed significant treatment effects on both days. Gabapentin was associated with less %stage1 on Day 1, and greater %REM on Day 28, versus placebo. During home use, gabapentin resulted in significantly less participant-reported WASO and higher ratings of sleep quality. Gabapentin was well tolerated (most common adverse events: headache, somnolence) with no evidence of next-day impairment.
  
  
  
  Gabapentin 250 mg resulted in greater PSG and participant-reported sleep duration following a 5-h phase advance on Day 1 and Day 28 of use without evidence of next-day impairment, and greater sleep duration during at-home use.
authors.affiliation: Pfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
authors.forename: Sandy A
authors.initials: SA
authors.lastname: Furey
authors.affiliation: Vince and Associates Clinical Research, Overland Park, KS.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Hull
authors.affiliation: California Clinical Trials, Glendale, CA.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Leibowitz
authors.affiliation: Pfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
authors.forename: Shyamalie
authors.initials: S
authors.lastname: Jayawardena
authors.affiliation: Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000588:Amines / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D017286:Polysomnography / Q000187:drug effects* / Q000379:methods* / Q000706:statistics & numerical data; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D012894:Sleep Stages / Q000187:drug effects*; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D002121:Calcium Channel Blockers; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
keywords: Gabapentin; insomnia; polysomnography; sleep phase advance; transient