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. 2009;11(6):292-301.
doi: 10.4088/PCC.08m00749bro.

The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: a pilot study

Thomas Roth  1 , Janet M Price, David A Amato, Robert P Rubens, James M Roach, Thomas J Schnitzer
Affiliations

The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: a pilot study

Thomas Roth et al. Prim Care Companion J Clin Psychiatry. 2009.

Abstract

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 < .05 vs placebo). At week 4, 48% of eszopiclone-treated patients had no clinically meaningful insomnia as assessed by ISI score (versus 30% of placebo-treated patients, 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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Figures

Figure 1
Figure 1
Median at Baseline and Weeks 1, 2, 3, and 4a aAnalysis of covariance change from baseline vs. placebo. *P < .05. **P < .01. ***P < .0001.
Figure 1
Figure 1
Median at Baseline and Weeks 1, 2, 3, and 4a aAnalysis of covariance change from baseline vs. placebo. *P < .05. **P < .01. ***P < .0001.
Figure 1
Figure 1
Median at Baseline and Weeks 1, 2, 3, and 4a aAnalysis of covariance change from baseline vs. placebo. *P < .05. **P < .01. ***P < .0001.
Figure 1
Figure 1
Median at Baseline and Weeks 1, 2, 3, and 4a aAnalysis of covariance change from baseline vs. placebo. *P < .05. **P < .01. ***P < .0001.
Figure 1
Figure 1
Median at Baseline and Weeks 1, 2, 3, and 4a aAnalysis of covariance change from baseline vs. placebo. *P < .05. **P < .01. ***P < .0001.
Figure 2
Figure 2
Daytime Functioning: Mean Double-Blind Averagesa aThe analysis used an analysis of variance on rank-transformed data with treatment and site as fixed effects. *P < .05.
Figure 3
Figure 3
Median Minutes at Baseline, End of Double-Blind Phase, and Each of 14 Days During the Single-Blind Placebo Washout Period
Figure 3
Figure 3
Median Minutes at Baseline, End of Double-Blind Phase, and Each of 14 Days During the Single-Blind Placebo Washout Period
Figure 3
Figure 3
Median Minutes at Baseline, End of Double-Blind Phase, and Each of 14 Days During the Single-Blind Placebo Washout Period
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