Effect of eszopiclone on sleep disturbances and daytime fatigue in multiple sclerosis patients.

The prevalence of moderate-to-severe sleep problems is significantly higher among people with multiple sclerosis (MS) than in the general population. In 2002, we found a significant relationship between fatigue and disrupted sleep in patients with relapsing-remitting MS (RRMS). The objectives of this study were to determine whether eszopiclone (Lunesta; Sunovion Pharmaceuticals Inc, Marlborough, MA) was superior to placebo in improving sleep among patients with MS-related fatigue and sleep complaints (primary end point); and to assess the impact of improved sleep on daytime fatigue and functioning (secondary end point). This was a double-blind, placebo-controlled pilot trial lasting 7 weeks. Thirty ambulatory adults under age 65 years with RRMS, fatigue, and sleep disturbances were randomized to receive either eszopiclone or placebo. The outcome measures included subjective and objective changes in sleep-onset latency (SOL), total sleep time (TST), wakefulness after sleep onset (WASO), sleep efficiency (SE), fatigue scales, and neuropsychological measures of daytime functioning. Compared with placebo, eszopiclone was superior only in increasing TST. Fatigue improved in both groups, but there was no statistically significant correlation between increased TST and improved fatigue, and no statistically significant differences were observed between the two groups. Thus, in this study, eszopiclone did not improve sleep sufficiently to improve fatigue in MS patients. This result may be due to the multifactorial nature of sleep disturbances and fatigue in people with MS.

RCT Entities:   Population Interventions Outcomes