title: Long-term nightly treatment with indiplon in adults with primary insomnia: results of a double-blind, placebo-controlled, 3-month study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of indiplon in primary insomnia.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, 3-month study.
  
  
  METHODS
  Multi-center outpatient setting.
  
  
  METHODS
  N=702 (61% female; mean age 46 years) who met DSM-IV criteria for primary insomnia of at least 3 months' duration.
  
  
  METHODS
  Indiplon 10 mg (n=236), indiplon 20 mg (n=233), or placebo (n=233).
  
  
  METHODS
  Subjective assessment of each of the following: latency to sleep onset (sLSO), total sleep time (sTST), number of awakenings after sleep onset (sNAASO), wake time after sleep onset (sWASO), sleep quality, Insomnia Severity Index (ISI), and global improvement.
  
  
  RESULTS
  Treatment with indiplon resulted in significant improvement relative to placebo at all time points for the primary endpoint, sLSO. Mean sLSO at Month 1 for each treatment group was: 10 mg (34.0 +/- 1.3 mins), 20 mg (33.0 +/- 1.3 mins), and placebo (48.7 +/- 1.9 mins; P <0.0001 for both comparisons); efficacy was sustained through Month 3. Both doses of indiplon resulted in significant improvement in sleep maintenance and duration endpoints, sTST and sWASO, as well as sleep quality, ISI, and global improvement at all assessment time points.
  
  
  CONCLUSIONS
  In patients with chronic insomnia, long-term nightly treatment with 10 mg and 20 mg doses of indiplon resulted in significant and sustained efficacy in sleep onset, maintenance, and duration, and significant associated improvement in both daytime functioning and quality of life.
authors.affiliation: Tri-State Sleep Disorders Center Cincinnati, OH, USA. sleepsat1@aol.com
authors.forename: Martin B
authors.initials: MB
authors.lastname: Scharf
authors.forename: Jed
authors.initials: J
authors.lastname: Black
authors.forename: Steven
authors.initials: S
authors.lastname: Hull
authors.forename: Rick
authors.initials: R
authors.lastname: Landin
authors.forename: Robert
authors.initials: R
authors.lastname: Farber
mesh_terms: D000328:Adult; D001569:Benzodiazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D006993:Hypnotics and Sedatives; D013876:Thiophenes; D001569:Benzodiazepines; C469870:indiplon