title: Efficacy and safety of doxepin 6 mg in a four-week outpatient trial of elderly adults with chronic primary insomnia.
abstract: BACKGROUND
  The efficacy and safety of doxepin (DXP), a histamine H(1) receptor antagonist, was evaluated in elderly adults with sleep maintenance insomnia.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled outpatient trial. Elderly adults meeting DSM-IV-TR criteria for primary insomnia were randomized to four weeks of nightly treatment with either DXP 6 mg (N=130) or placebo (PBO; N=124). Efficacy was assessed using patient self-report instruments and clinician ratings. Patient-reported endpoints included subjective total sleep time (sTST), subjective wake after sleep onset (sWASO), latency to sleep onset (LSO), sleep quality, and a Patient Global Impression scale (PGI). The primary endpoint was sTST at week 1.
  
  
  RESULTS
  DXP 6 mg produced significantly more sTST and less sWASO at week 1 (both p-values <0.0001) than PBO. These significant improvements versus placebo were maintained at weeks 2-4 (all p-values <0.05). There were no significant differences in LSO for DXP 6 mg versus PBO. DXP 6 mg significantly improved sleep quality (weeks 1, 3, and 4, p<0.05) and several outcome-related parameters, including several items on the PGI, the severity and improvement items of the Clinician Global Impression scale (CGI; weeks 1 and 2) and the Insomnia Severity Index (ISI; weeks 1-4), all versus PBO. There were no reports of anticholinergic effects (e.g., dry mouth) or memory impairment. The safety profile of DXP 6 mg was comparable to that of PBO.
  
  
  CONCLUSIONS
  In elderly adults with insomnia, DXP 6 mg produced significant improvements in sleep maintenance, sleep duration, and sleep quality endpoints that were sustained throughout the trial. These data suggest that DXP 6 mg is effective for treating sleep maintenance insomnia and is well-tolerated in elderly adults with chronic primary insomnia.
authors.affiliation: Sleep Disorders Center of Georgia, 5505 Peachtree Dunwoody Road, Suite 380, Atlanta, GA 30342, USA. alankford@sleepsciences.com
authors.forename: Alan
authors.initials: A
authors.lastname: Lankford
authors.forename: Roberta
authors.initials: R
authors.lastname: Rogowski
authors.forename: Beal
authors.initials: B
authors.lastname: Essink
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ludington
authors.forename: H
authors.initials: H
authors.lastname: Heith Durrence
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D004316:Doxepin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010919:Placebos; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D006634:Histamine H1 Antagonists; D010919:Placebos; D004316:Doxepin