title: Pilot Study on the Effect of Ramelteon on Sleep Disturbance After Traumatic Brain Injury: Preliminary Evidence From a Clinical Trial.
abstract: OBJECTIVE
  To investigate the effect of ramelteon on sleep and daytime functioning among individuals with traumatic brain injury (TBI).
  
  
  METHODS
  A double-blind, placebo-controlled study with a crossover design.
  
  
  METHODS
  A research facility attached to an acute rehabilitation hospital.
  
  
  METHODS
  Individuals with TBI (N=13) complaining of sleep difficulties with a Pittsburgh Sleep Quality Index score >5.
  
  
  METHODS
  A nightly dosage of ramelteon (8 mg) was given over a period of 3 weeks.
  
  
  METHODS
  An actigraph and a daily sleep log were used to measure sleep/wake patterns. Daytime functioning was measured after 3 weeks of treatment using a computer-administrated neuropsychological test battery in conjunction with subjective questionnaires measuring mood, daytime sleepiness, and fatigue.
  
  
  RESULTS
  A significant increase in objectively measured total sleep time and a small increase in sleep latency were observed after 3 weeks of treatment compared with placebo. Treatment also showed a significant increase in standardized neuropsychological test scores, with a particular improvement on an index of executive functioning.
  
  
  CONCLUSIONS
  Preliminary evidence for the effectiveness of 8 mg of ramelteon taken nightly over a 3-week period was found in the treatment of sleep difficulties among individuals with TBI. Improvements in total sleep time and some aspects of cognitive functioning are discussed.
authors.affiliation: Kessler Foundation, West Orange, NJ; Department of Physical Medicine and Rehabilitation, Rutgers, New Jersey Medical School, Newark, NJ. Electronic address: alequerica@kesslerfoundation.org.
authors.forename: Anthony
authors.initials: A
authors.lastname: Lequerica
authors.affiliation: Kessler Institute for Rehabilitation, West Orange, NJ.
authors.forename: Neil
authors.initials: N
authors.lastname: Jasey
authors.affiliation: Robert Wood Johnson Medical School, Rutgers University, New Brunswick, NJ.
authors.forename: Jaclyn N
authors.initials: JN
authors.lastname: Portelli Tremont
authors.affiliation: Kessler Foundation, West Orange, NJ; Department of Physical Medicine and Rehabilitation, Rutgers, New Jersey Medical School, Newark, NJ.
authors.forename: Nancy D
authors.initials: ND
authors.lastname: Chiaravalloti
mesh_terms: D000328:Adult; D001930:Brain Injuries / Q000150:complications* / Q000503:physiopathology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007192:Indenes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D007192:Indenes; C495910:ramelteon
keywords: Brain injuries; Cognition; Rehabilitation; Sleep