title: Efficacy of vestipitant, a neurokinin-1 receptor antagonist, in primary insomnia.
abstract: OBJECTIVE
  Investigate the hypnotic effects of repeated doses of neurokinin-1 receptor antagonist, vestipitant, in primary insomnia.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled 28-day parallel-group study.
  
  
  METHODS
  Eleven sleep centers in Germany.
  
  
  METHODS
  One hundred sixty-one patients with primary insomnia.
  
  
  METHODS
  Patients received vestipitant (15 mg) or placebo for 28 days; 2-night polysomnographic assessment occurred on nights 1/2 and 27/28.
  
  
  RESULTS
  Wake after sleep onset (WASO) was improved on nights 1/2 and 27/28 (ratio, vestipitant versus placebo [95% confidence interval]: 0.76 [0.65, 0.90], P = 0.001 and 0.79 [0.65, 0.96], P = 0.02, respectively), demonstrating maintenance of the effect following repeated dosing. Latency to persistent sleep was shorter with vestipitant on nights 1/2 (P = 0.0006 versus placebo), but not on nights 27/28. Total sleep time (TST) improved with vestipitant (nights 1/2: P < 0.0001, nights 27/28: P = 0.02 versus placebo). Next-day cognitive function tests demonstrated no residual effects of vestipitant (P > 0.05 versus placebo). Adverse events (AEs) occurred in 25% of vestipitant patients versus 22% for placebo. Headache was the most common AE (8% of vestipitant patients versus 9% for placebo).
  
  
  CONCLUSIONS
  Vestipitant improved sleep maintenance in patients with primary insomnia, with no associated next-day cognitive impairment. The effects on wake after sleep onset and total sleep time were maintained following repeated dosing.
authors.affiliation: GlaxoSmithKline Neuroscience Centre of Excellence for Drug Discovery, Verona, Italy.
authors.forename: Emiliangelo
authors.initials: E
authors.lastname: Ratti
authors.forename: David J
authors.initials: DJ
authors.lastname: Carpenter
authors.forename: Stefano
authors.initials: S
authors.lastname: Zamuner
authors.forename: Sofia
authors.initials: S
authors.lastname: Fernandes
authors.forename: Lisa
authors.initials: L
authors.lastname: Squassante
authors.forename: Heidi
authors.initials: H
authors.lastname: Danker-Hopfe
authors.forename: Graeme
authors.initials: G
authors.lastname: Archer
authors.forename: Jonathan
authors.initials: J
authors.lastname: Robertson
authors.forename: Robert
authors.initials: R
authors.lastname: Alexander
authors.forename: David G
authors.initials: DG
authors.lastname: Trist
authors.forename: Emilio
authors.initials: E
authors.lastname: Merlo-Pich
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D064729:Neurokinin-1 Receptor Antagonists / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D017286:Polysomnography; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005464:Fluorobenzenes; D064729:Neurokinin-1 Receptor Antagonists; D010880:Piperidines; C534550:vestipitant
keywords: Cognition; NK-1 receptor antagonist; insomnia; placebo; polysomnography; sleep; substance P receptor; vestipitant