title: Examination of nighttime sleep-related problems during double-blind, placebo-controlled trials of galantamine in patients with Alzheimer's disease.
abstract: BACKGROUND
  Acetylcholinesterase inhibitors (AChEI) are now widely used as treatment for Alzheimer's disease (AD). Their cholinomimetic action has the potential to influence sleep quality and donepezil has been associated with sleeprelated adverse events. This study examined whether galantamine, an AChEI with nicotinic modulation, is associated with nighttime sleeprelated problems.
  
  
  METHODS
  Using data combined from three randomized, double-blind trials, galantamine (GAL) and placebo-treated patients were compared on sleep-related adverse events and concomitant medications. Verbatim descriptions by patients, as recorded by physicians, were used to classify adverse events into insomnia/sleep problems and nightmares/dreams. New concomitant medications findings from double-blind, placebo-controlled were counted when prescribed for sleep-related indications. Treatment arms were 705 subjects on GAL 24 mg (12 mg BID), 279 on GAL 16 mg (8 mg BID), and 714 on placebo.
  
  
  RESULTS
  Comparing GAL 24, GAL 16, and placebo arms, the respective rates for insomnia/sleep problems were 2.6, 1.1, and 2.2% and for nightmares were 1.1, 0.4, and 0.1%. Comparisons between GAL arms and placebo were not significant, with the exception of GAL 24 for nightmares (p = 0.02). However, due to the low frequency of nightmares in each group the clinical relevance of this difference is unknown. Rates of use for all concomitant medications indicated for sleep were 5.4, 2.9, and 4.6%, respectively, with no significant differences between GAL arms and placebo.
  
  
  CONCLUSIONS
  These results support previous studies that have shown maintenance of good sleep hygiene during treatment with galantamine.
authors.affiliation: Department of Psychiatry, University of California at San Diego and Neuroscience Education Institute, San Diego, CA 92008, USA. smstahl@neiglobal.com
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Stahl
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Markowitz
authors.forename: George
authors.initials: G
authors.lastname: Papadopoulos
authors.forename: Kay
authors.initials: K
authors.lastname: Sadik
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy*; D002800:Cholinesterase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D004325:Dreams / Q000187:drug effects; D005702:Galantamine / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D018697:Nootropic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D012893:Sleep Wake Disorders / Q000139:chemically induced*
chemical_list: D002800:Cholinesterase Inhibitors; D018697:Nootropic Agents; D005702:Galantamine