title: Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta®) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study.
abstract: OBJECTIVE
  A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs. The authors designed a randomized, double blind, placebo-controlled, parallel-group, pilot study in which migraineurs who also had insomnia were enrolled, to test this observation.
  
  
  METHODS
  In the study, the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone (Lunesta(®)) or placebo at bedtime. The treatment was preceded by a 2-week baseline period and followed by a 2-week run-out period.
  
  
  RESULTS
  Of the 79 subjects treated, 75 were evaluable, 35 in the eszopiclone group, and 40 in the placebo group. At baseline, the groups were comparable except for sleep latency. Of the three remaining sleep variables, total sleep time, nighttime awakenings, and sleep quality, the number of nighttime awakenings during the 6-week treatment period was significantly lower in the eszopiclone group than in the placebo group (P = 0.03). Of the three daytime variables, alertness, fatigue, and functioning, this was also the case for fatigue (P = 005). The headache variables, frequency, duration, and intensity, did not show a difference from placebo during the 6-week treatment period.
  
  
  CONCLUSIONS
  The study did not meet primary endpoint, that is, the difference in total sleep time during the 6-week treatment period between eszopiclone and placebo was less than 40 minutes. Therefore, it failed to answer the question as to whether insomnia is, indeed, a risk factor for increased headache frequency and headache intensity in migraineurs.
authors.forename: Egilius L H
authors.initials: EL
authors.lastname: Spierings
authors.forename: Peter J
authors.initials: PJ
authors.lastname: McAllister
authors.forename: Tanya R
authors.initials: TR
authors.lastname: Bilchik
mesh_terms: D000293:Adolescent; D000328:Adult; D053961:Azabicyclo Compounds / Q000627:therapeutic use*; D004311:Double-Blind Method; D000069582:Eszopiclone; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000209:etiology*; D010865:Pilot Projects; D010879:Piperazines / Q000627:therapeutic use*; D012307:Risk Factors; D007319:Sleep Initiation and Maintenance Disorders / Q000150:complications* / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D000069582:Eszopiclone
keywords: Eszopiclone,; Headache frequency; Insomnia,; Migraine,; Total sleep time,