title: Patient Background Factors Affecting the Therapeutic Outcomes in Response to Eszopiclone in Adult Patients with Chronic Insomnia: A Post Hoc Analysis of a Double-Blind Phase III Study in Japan.
abstract: OBJECTIVE
  To identify whether baseline demographic factors or subjective sleep variables are associated with the outcomes following treatment with eszopiclone using data from a recent randomized controlled trial of 78 Japanese subjects with insomnia who were treated with 2 mg eszopiclone per day.
  
  
  METHODS
  We performed a post hoc analysis of factors including sleep latency (SL), wake time after sleep onset (WASO) (both assessed via sleep diaries), and several demographic variables. Subjects with a SL or WASO > 30 min at baseline and with evaluable SL/WASO data at Week 4 were included in SL and WASO remitter analyses, respectively; those with a SL or WASO ≤ 30 min at Week 4 were defined as SL or WASO remitters, respectively. Threshold baseline SL and WASO values for identification of remitters were determined.
  
  
  RESULTS
  No relationships between subjectively assessed therapeutic outcomes and demographic factors were identified. Patients with shorter SL and lower WASO values at baseline showed better outcomes following treatment with eszopiclone in terms of SL and WASO changes, respectively. Baseline SL of 75 min and baseline WASO of 80 min were selected as arbitrary cutoff values for determination of SL and WASO remitters/non-remitters, respectively.
  
  
  CONCLUSIONS
  These findings may help clinicians to predict their patients' outcomes in response to standard doses of eszopiclone in clinical practice.
authors.affiliation: Department of Somnology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: Eisai Co., Ltd, Tokyo, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kamijo
authors.affiliation: Eisai Co., Ltd, Tokyo, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Nagai
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D000069582:Eszopiclone / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D012737:Sex Factors; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects; D055815:Young Adult
chemical_list: D006993:Hypnotics and Sedatives; D000069582:Eszopiclone
keywords: benzodiazepine receptor agonists; short-acting hypnotics; sleep latency; sleep maintenance insomnia; sleep-onset insomnia; wake after sleep onset