title: A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance.
abstract: To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model.
  
  
  
  Adults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD). Next-day residual effects (Digit Symbol Substitution Test [DSST] and Stanford Sleepiness Scale [SSS]) and tolerability were assessed.
  
  
  
  Demographics were comparable among groups. Among PSG endpoints, wake after sleep onset (primary endpoint) (135.7 [placebo], 100.7 [250 mg], and 73.2 [500 mg] min) was significantly lower and total sleep time (TST) (311.4, 356.5, and 378.7 min) significantly greater in both gabapentin groups versus placebo. Latency to persistent sleep was not significantly different among groups. Percent slow wave sleep (12.6%, 15.4%, and 17.0%, respectively) was significantly greater and percent stage 1 (15.1%, 11.8%, and 10.8%, respectively) significantly lower relative to placebo. Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant. Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS. Adverse events were infrequent (< 5%).
  
  
  
  Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth (versus placebo) in response to a phase advance manipulation known to disrupt sleep maintenance.
authors.affiliation: Neurotrials Research Inc., Atlanta, GA.
authors.forename: Russell P
authors.initials: RP
authors.lastname: Rosenberg
authors.affiliation: Vince and Associates Clinical Research, Overland Park, KS.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Hull
authors.affiliation: Sleep Disorders Center of Georgia, Atlanta, GA.
authors.forename: D Alan
authors.initials: DA
authors.lastname: Lankford
authors.affiliation: Community Research, Cincinnati, OH.
authors.forename: David W
authors.initials: DW
authors.lastname: Mayleben
authors.affiliation: Miami Research Associates, Miami, FL.
authors.forename: David J
authors.initials: DJ
authors.lastname: Seiden
authors.affiliation: Pfizer Consumer Healthcare, Pfizer Inc, Madison, NJ.
authors.forename: Sandy A
authors.initials: SA
authors.lastname: Furey
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*; 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; treatment