title: Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder.
abstract: OBJECTIVE
  To evaluate efficacy and safety of eszopiclone compared with placebo in children and adolescents with insomnia associated with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  A 12-week, randomized, double-blind, placebo-controlled trial evaluated efficacy and safety of high- or low-dose eszopiclone (1 or 2 mg in children aged 6-11 years, 2 or 3 mg in children ages 12-17 years), given every evening, in 486 patients with ADHD-related insomnia. The primary efficacy variable was change in latency to persistent sleep from baseline to week 12, based on polysomnography. Key secondary measures were polysomnography-measured wake time after sleep onset, Clinical Global Impression Parent/Caregiver and Child scales, and the Conners' ADHD rating scales. The safety of eszopiclone was further studied over 1 year of open-label treatment in 55 patients who completed the double-blind study, and 249 patients with no previous eszopiclone exposure.
  
  
  RESULTS
  Neither low-dose nor high-dose eszopiclone significantly reduced latency to persistent sleep compared with placebo after 12 weeks of treatment. Secondary outcomes were considered nonsignificant based on the hierarchical statistical analysis plan. The most frequent treatment-emergent adverse events over 12 weeks with eszopiclone were headache, dysgeusia, and dizziness. The study results demonstrated that eszopiclone was well tolerated over 1 year of treatment, with 11.2% of patients discontinuing open-label treatment because of an adverse event.
  
  
  CONCLUSIONS
  Eszopiclone (up to 3 mg) failed to reduce latency to persistent sleep on polysomnography after 12 weeks in children aged 6 to 17 years with ADHD-related insomnia. Eszopiclone was well tolerated in the 1-year study.
authors.affiliation: Sleep Disorders Institute and Attention Disorders Institute, Sterling Heights, Michigan; Oakland University William Beaumont School of Medicine, Rochester Hills, Michigan; sangalrb@sleepwebmd.com.
authors.forename: R Bart
authors.initials: RB
authors.lastname: Sangal
authors.affiliation: Department of Pediatrics, College of Medicine and Life Sciences, The University of Toledo, Toledo, Ohio;
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Blumer
authors.affiliation: Sleep Disorders Center of Georgia, Atlanta, Georgia; and.
authors.forename: D Alan
authors.initials: DA
authors.lastname: Lankford
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts.
authors.forename: Todd A
authors.initials: TA
authors.lastname: Grinnell
authors.affiliation: Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts.
authors.forename: Holly
authors.initials: H
authors.lastname: Huang
mesh_terms: D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D053961:Azabicyclo Compounds / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000069582:Eszopiclone; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D017286:Polysomnography / Q000379:methods; D016037:Single-Blind Method; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D000069582:Eszopiclone
keywords: ADHD; benzodiazepine agonist; eszopiclone; pediatric insomnia