A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain

Sleep. 2014 Jun 1;37(6):1053-60. doi: 10.5665/sleep.3760.


Study objectives: 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.

Design: Double-blind, placebo-controlled, parallel-group, 1-mo trial.

Setting: Duke University Medical Center Outpatient Sleep Clinic.

Patients: 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).

Interventions: Subjects were randomized to eszopiclone (ESZ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day.

Measurements and 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.

Trial registration: clinicaltrials.gov identifier: NCT00365976.

Keywords: eszopiclone; insomnia; low back pain.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Azabicyclo Compounds / adverse effects
  • Azabicyclo Compounds / therapeutic use*
  • Double-Blind Method
  • Eszopiclone
  • Female
  • Humans
  • Hypnotics and Sedatives / adverse effects
  • Hypnotics and Sedatives / therapeutic use*
  • Low Back Pain / complications*
  • Male
  • Middle Aged
  • Pain Measurement
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Sleep
  • Sleep Initiation and Maintenance Disorders / complications*
  • Sleep Initiation and Maintenance Disorders / diagnosis
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Treatment Outcome
  • Young Adult


  • Azabicyclo Compounds
  • Hypnotics and Sedatives
  • Piperazines
  • Eszopiclone

Associated data

  • ClinicalTrials.gov/NCT00365976