Objective: To evaluate the efficacy and safety of eszopiclone 3 mg, a nonbenzodiazepine medication/hypnotic indicated for the treatment of insomnia with comorbid rheumatoid arthritis (RA).
Method: This multicenter, double-blind, placebo-controlled pilot study was conducted in 153 patients aged 25-64 years with American College of Rheumatology-defined RA who met DSM-IV criteria for insomnia. The data were collected from February to November of 2004. Patients were randomly assigned to either eszopiclone or placebo nightly for 4 weeks, followed by a 2-week placebo run out. Efficacy was evaluated using patient reports of sleep (wake time after sleep onset [WASO], sleep latency [SL], and total sleep time [TST]), daytime function, pain, and RA assessments. Insomnia severity was evaluated using the Insomnia Severity Index. Safety was also evaluated.
Results: Eszopiclone significantly improved all patient-reported sleep measures (WASO, SL, and TST), sleep quality, depth of sleep, and daytime function (P P =.03). Eszopiclone was significantly better than placebo on some RA-associated pain measures: (1) overall (P =.05), pain (P =.006), and pain and other symptoms (P =.02) scores of the Arthritis Self-Efficacy Scale, (2) tender joint counts (P =.03) and pain severity scores (P =.023), (3) the activities domain of the Health Assessment Questionnaire-Disability Index (P =.04), and (4) the role physical (P =.03) and bodily pain (P =.01) scales of the 36-item Medical Outcomes Study Short-Form General Health Survey. The most commonly reported adverse events with eszopiclone were unpleasant taste and transient increases in RA symptoms
Conclusions: In this pilot study of patients with insomnia comorbid with RA, eszopiclone 3 mg improved all assessed sleep and daytime function measures over the treatment period, as well as some measures of RA-associated pain, disability, and quality of life
Trial Registration: clinicaltrials.gov Identifier: NCT00367965
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