title: A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain.
abstract: OBJECTIVE
  Insomnia, which is very common in patients with chronic low back pain (LBP), has long been viewed as a pain symptom that did not merit specific treatment. Recent data suggest that adding insomnia therapy to pain-targeted treatment should improve outcome; however, this has not been empirically tested in LBP or in any pain condition treated with a standardized pain medication regimen. We sought to test the hypothesis that adding insomnia therapy to pain-targeted treatment might improve sleep and pain in LBP.
  
  
  METHODS
  Double-blind, placebo-controlled, parallel-group, 1-mo trial.
  
  
  METHODS
  Duke University Medical Center Outpatient Sleep Clinic.
  
  
  METHODS
  Fifty-two adult volunteers with LBP of at least 3 mo duration who met diagnostic criteria for insomnia (mean age: 42.5 y; 63% females).
  
  
  METHODS
  Subjects were randomized to eszopiclone (ESZ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day.
  
  
  RESULTS
  ESZ SIGNIFICANTLY IMPROVED TOTAL SLEEP TIME (MEAN INCREASE: ESZ, 95 min; placebo, 9 min) (primary outcome) and nearly all sleep measures as well as visual analog scale pain (mean decrease: ESZ, 17 mm; placebo, 2 mm) (primary pain outcome), and depression (mean Hamilton Depression Rating Scale improvement ESZ, 3.8; placebo, 0.4) compared with placebo. Changes in pain ratings were significantly correlated with changes in sleep.
  
  
  CONCLUSIONS
  The addition of insomnia-specific therapy to a standardized naproxen pain regimen significantly improves sleep, pain, and depression in patients with chronic low back pain (LBP). The findings indicate the importance of administering both sleep and pain-directed therapies to patients with LBP in clinical practice and provide strong evidence that improving sleep disturbance may improve pain.
  
  
  BACKGROUND
  clinicaltrials.gov identifier: NCT00365976.
authors.affiliation: Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research Program, Duke University Medical Center; Attending Physician (GRECC), Durham Veterans Affairs Medical Center, Durham, NC.
authors.forename: Harold W
authors.initials: HW
authors.lastname: Goforth
authors.affiliation: Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research Program, Duke University Medical Center, Durham, NC.
authors.forename: Xavier A
authors.initials: XA
authors.lastname: Preud'homme
authors.affiliation: Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research Program, Duke University Medical Center; Attending Physician (GRECC), Durham Veterans Affairs Medical Center, Durham, NC.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krystal
mesh_terms: D000328:Adult; D053961:Azabicyclo Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D000069582:Eszopiclone; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D017116:Low Back Pain / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D000069582:Eszopiclone
keywords: eszopiclone; insomnia; low back pain