title: The effects of ramelteon in a first-night model of transient insomnia.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of ramelteon, a highly selective MT(1)/MT(2) melatonin receptor agonist, for the treatment of transient insomnia in adults.
  
  
  METHODS
  In a randomized, double-blind, placebo-controlled, multi-center study, 289 adults naive to a sleep laboratory environment were randomized to receive a single nighttime dose of ramelteon 8 mg, 16 mg, or placebo. The primary variable was latency to persistent sleep measured by polysomnography. Additional objective and subjective sleep parameters as well as next-morning residual effects were assessed.
  
  
  RESULTS
  Ramelteon 8 mg treatment significantly reduced latency to persistent sleep compared with placebo (12.2 min vs. 19.7 min, P=0.004). Total sleep time was significantly increased with both ramelteon 8 mg (436.8 min, P=0.009) and ramelteon 16 mg (433.1 min, P=0.043) compared with placebo (419.7 min). Ramelteon did not alter sleep architecture, and no significant next-morning residual effects were detected. The incidence of adverse events was similar for the ramelteon and placebo groups and most were considered mild or moderate.
  
  
  CONCLUSIONS
  Ramelteon 8 mg significantly decreased latency to persistent sleep and increased total sleep time, with no significant next-morning psychomotor, memory, or cognitive effects in this first-night model of transient insomnia.
authors.affiliation: Clinilabs Sleep Disorder Institute, 423 West 55th Street, New York, NY 10019, USA. gzammit@clinilabs.com
authors.forename: Gary
authors.initials: G
authors.lastname: Zammit
authors.forename: Howard
authors.initials: H
authors.lastname: Schwartz
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
authors.forename: Sherry
authors.initials: S
authors.lastname: Wang-Weigand
authors.forename: Steve
authors.initials: S
authors.lastname: Sainati
authors.forename: Jeff
authors.initials: J
authors.lastname: Zhang
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007192:Indenes / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D010919:Placebos; D017286:Polysomnography; D044123:Receptor, Melatonin, MT2 / Q000819:agonists*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D007192:Indenes; D010919:Placebos; D044123:Receptor, Melatonin, MT2; C495910:ramelteon