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VOLUME 37, ISSUE 06

ESZOPICLONE FOR THE TREATMENT OF INSOMNIA IN PATIENTS WITH LOW BACK PAIN
A Randomized, Double-Blind, Placebo-Controlled Trial of Eszopiclone for the Treatment of Insomnia in Patients with Chronic Low Back Pain

http://dx.doi.org/10.5665/sleep.3760

Harold W. Goforth, MD1; Xavier A. Preud'homme, MD2; Andrew D. Krystal, MD, MS1

1Assistant 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; 2Assistant Professor of Medicine and Psychiatry, Duke Insomnia and Sleep Research Program, Duke University Medical Center, Durham, NC; 3Professor of Psychiatry and Director, Duke Insomnia and Sleep Research Program, Duke University Medical Center, Durham, NC



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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

Citation:

Goforth HW, Preud'homme XA, Krystal AD. A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain. SLEEP 2014;37(6):1053-1060.

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