title: Use of a post-sleep questionnaire-interactive voice response system (PSQ-IVRS) to evaluate the subjective sleep effects of ramelteon in adults with chronic insomnia.
abstract: OBJECTIVE
  Ramelteon is an MT(1)/MT(2) melatonin receptor agonist approved in the US and Japan for the treatment of sleep-onset insomnia. This study evaluated the effects of ramelteon 8mg on patient reported sleep parameters in adults with chronic insomnia in an at-home setting using a post-sleep questionnaire-interactive voice response system (PSQ-IVRS).
  
  
  METHODS
  Adults aged 18-64 years with chronic insomnia were randomized to receive ramelteon 8 mg or placebo nightly for 3weeks. Sleep parameters were assessed via PSQ-IVRS within 60 min of awakening each morning. Adverse effects were collected throughout the study.
  
  
  RESULTS
  A total of 552 subjects (mean age 43.2 years) received treatment (274 ramelteon, 278 placebo). There was a reduction in mean sleep latency at weeks 1, 2, and 3 compared with placebo but none reached statistical significance (-4.1 min, p=0.088 week 1; -2.8 min, p=0.258 week 2; -4.9 min, p=0.060 week 3). There were no significant differences between placebo and ramelteon in other PSQ-IVRS sleep parameters. Only headache (18 [6.5%] placebo, 18 [6.6%] ramelteon) and somnolence (5 [1.8%], 12 [4.4%] ramelteon) occurred in>3% of subjects.
  
  
  CONCLUSIONS
  Use of ramelteon 8 mg in an at-home setting did not demonstrate statistically significant improvements in subjective sleep latency compared with placebo, when measured by PSQ-IVRS.
authors.affiliation: Takeda Pharmaceuticals International, Deerfield, IL, USA.
authors.forename: Sherry
authors.initials: S
authors.lastname: Wang-Weigand
authors.forename: Marie
authors.initials: M
authors.lastname: Watissée
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
mesh_terms: D000293:Adolescent; D000328:Adult; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy; D005260:Female; D006801:Humans; D007192:Indenes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017286:Polysomnography; D044122:Receptor, Melatonin, MT1 / Q000819:agonists; D044123:Receptor, Melatonin, MT2 / Q000819:agonists; D015203:Reproducibility of Results; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis* / Q000188:drug therapy*; D011795:Surveys and Questionnaires / Q000592:standards*; D013685:Telecommunications / Q000592:standards*; D055815:Young Adult
chemical_list: D007192:Indenes; D010919:Placebos; D044122:Receptor, Melatonin, MT1; D044123:Receptor, Melatonin, MT2; C495910:ramelteon