title: Dual Orexin Receptor Antagonist, Almorexant, in Elderly Patients With Primary Insomnia: A Randomized, Controlled Study.
abstract: Sleep laboratory study to determine the dose-related efficacy and safety of almorexant in elderly patients with primary chronic insomnia.
  
  
  
  Patients aged ≥65 years with primary insomnia were enrolled into a prospective, randomized, double-blind, placebo-controlled, multicenter dose-finding study with a five-period, five-way Latin square cross-over design. Patients were randomized to one of 10 unique sequences of two-night treatment with oral almorexant 25, 50, 100, or 200 mg capsules, or matching placebo. The primary efficacy endpoint was polysomnography (PSG)-determined mean wake time after sleep onset (WASO). Secondary and exploratory efficacy endpoints were also assessed.
  
  
  
  112 patients were randomized (mean [SD] age 72.1 [5.0] years; 69.9% female). Significant, dose-related improvements (reductions) in mean WASO were observed with almorexant. Least-squares mean (95% CI) treatment effects in the almorexant 200, 100, 50, and 25 mg dose groups versus placebo were -46.5 minutes (-53.0, -39.9; p < .0001), -31.4 minutes (-38.0, -24.9; p < .0001), -19.2 minutes (-25.7, -12.6; p < .0001), and -10.4 minutes (-17.0, -3.9; p = .0018), respectively. Mean total sleep time was significantly increased with each almorexant dose (mean increases versus placebo ranged 55.1-14.3 minutes; p < .0001 for each dose). Latency to persistent sleep was statistically significantly reduced only with almorexant 200 mg versus placebo (mean [95% CI] treatment effect -10.2 minutes, [-15.4, -5.0]; p = .0001). No unexpected safety concerns were identified. Adverse events were similar between all almorexant dose groups and placebo.
  
  
  
  Two-night oral administration of almorexant was effective and well tolerated in treating primary insomnia in elderly patients.
authors.affiliation: Thomas Roth Sleep Disorders and Research Center, Detroit, MI.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
authors.affiliation: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.|Center for Sleep Research and Medicine, Stanford, CA.
authors.forename: Jed
authors.initials: J
authors.lastname: Black
authors.affiliation: Center for Sleep Research and Medicine, Stanford, CA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Cluydts
authors.affiliation: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.|Multidisciplinary Sleep Disorders Centre, University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Charef
authors.affiliation: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
authors.forename: Marzia
authors.initials: M
authors.lastname: Cavallaro
authors.affiliation: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Kramer
authors.affiliation: Clinilabs, New York, NY.
authors.forename: Gary
authors.initials: G
authors.lastname: Zammit
authors.affiliation: Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, MO.
authors.forename: James
authors.initials: J
authors.lastname: Walsh
mesh_terms: D000081:Acetamides / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D000068796:Orexin Receptor Antagonists / Q000627:therapeutic use*; D017286:Polysomnography; D011446:Prospective Studies; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000081:Acetamides; D007546:Isoquinolines; D000068796:Orexin Receptor Antagonists; C519150:almorexant
keywords: almorexant; efficacy.; insomnia; orexin