title: Melatonin fails to improve sleep or agitation in double-blind randomized placebo-controlled trial of institutionalized patients with Alzheimer disease.
abstract: OBJECTIVE
  Patients with Alzheimer dementia often display both agitated behavior and poor sleep. Given that the disease is often associated with low endogenous levels of melatonin, exogenous melatonin administration may lead to improvements in sleep and agitation.
  
  
  METHODS
  Randomized, placebo-controlled study.
  
  
  METHODS
  Nursing homes in San Diego, CA, metropolitan area.
  
  
  METHODS
  Subjects were patients with probable Alzheimer disease.
  
  
  METHODS
  Melatonin (8.5 mg immediate release and 1.5 mg sustained release) (N = 24) or placebo (N = 17) administered at 10:00 P.M. for 10 consecutive nights. The protocol consisted of baseline (3 days), treatment (10 days), and posttreatment (5 days) phases.
  
  
  METHODS
  Sleep was measured continuously using actigraphy. Agitation was rated using both the Agitated Behavior Rating Scale and the Cohen-Mansfield Agitation Inventory. Treatment effects were examined both across the 24-hr day and separately by nursing shift.
  
  
  RESULTS
  There were no significant effects of melatonin, compared with placebo, on sleep, circadian rhythms, or agitation.
  
  
  CONCLUSIONS
  : This study failed to find a beneficial effect of exogenous melatonin, consistent with a number of other studies. The lack of efficacy may be related to the absence of a true treatment effect or to the superphysiologic dose of melatonin used.
authors.affiliation: Department of Psychiatry, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Philip R
authors.initials: PR
authors.lastname: Gehrman
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Connor
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Martin
authors.forename: Tamar
authors.initials: T
authors.lastname: Shochat
authors.forename: Jody
authors.initials: J
authors.lastname: Corey-Bloom
authors.forename: Sonia
authors.initials: S
authors.lastname: Ancoli-Israel
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000150:complications*; D002492:Central Nervous System Depressants; D002940:Circadian Rhythm / Q000187:drug effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D015577:Geriatric Assessment; D006801:Humans; D008550:Melatonin / Q000008:administration & dosage / Q000627:therapeutic use*; D009735:Nursing Homes; D010919:Placebos / Q000627:therapeutic use; D017286:Polysomnography; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy*; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000188:drug therapy*
chemical_list: D002492:Central Nervous System Depressants; D010919:Placebos; D008550:Melatonin