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

ABSTRACT: 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.

SUBMITTER: Attarian H

PROVIDER: S-EPMC3882952 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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

Attarian Hrayr H Applebee Garrick G Applebee Angela A Wang Bingxia B Clark Melissa M McCormick Becky B Salzman Emma E Schuman Catherine C

International journal of MS care 20110101 2

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 compl ...[more]

PMID: 24453709

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Project description:BACKGROUND:Sleep disorders and fatigue are common in multiple sclerosis (MS). The underlying causes are not fully understood, and prospective studies are lacking. Therefore, we conducted a prospective, observational cohort study investigating sleep quality, fatigue, quality of life, and comorbidities in patients with MS. METHODS:Patients with relapsing-remitting MS or clinically isolated syndrome treated with interferon beta-1b were followed over two years. The primary objective was to investigate correlations between sleep quality (PSQI), fatigue (MFIS), and functional health status (SF-36). Secondary objectives were to investigate correlations of sleep quality and daytime sleepiness (ESS), depression (HADS-D), anxiety (HADS-A), pain (HSAL), and restless legs syndrome (RLS). We applied descriptive statistics, correlation and regression analyses. RESULTS:139 patients were enrolled, 128 were available for full analysis. The proportion of poor sleepers (PSQI?5) was 55.47% at the beginning and 37.70% by the end of the study (106 and 41 evaluable questionnaires, respectively). Poor sleepers performed worse in MFIS, SF-36, ESS, HADS-D, and HADS-A scores. The prevalence of patients with RLS was low (4.5%) and all were poor sleepers. Poor sleep quality was positively correlated with fatigue and low functional health status. These relationships were corroborated by multivariable-adjusted regression analyses. ESS values and poor sleep quality at baseline seem to predict sleep quality at the one-year follow-up. No variable predicted sleep quality at the two-year follow-up. CONCLUSIONS:Our results confirm the high prevalence of poor sleep quality among patients with MS and its persistent correlation with fatigue and reduced quality of life over time. They highlight the importance of interventions to improve sleep quality. TRIAL REGISTRATION:The study was registered at clinicaltrials.gov: NCT01766063 (registered December 7, 2012). Registered retrospectively (first patient enrolled December 6, 2012).

Project description:BackgroundNonmotor symptoms (NMS) are highly prevalent in cervical dystonia (CD). In general, fatigue and sleep are important NMS that determine a decreased health-related quality of life (HR-QoL), but their influence in CD is unknown. The authors systematically investigated fatigue, excessive daytime sleepiness (EDS), and sleep quality in patients with CD and controls and assessed the influence of psychiatric comorbidity, pain, and dystonia motor severity. They also examined the predictors of HR-QoL.MethodsThe study included 44 patients with CD and 43 matched controls. Fatigue, EDS, and sleep quality were assessed with quantitative questionnaires and corrected for depression and anxiety using analysis of covariance. The Toronto Western Spasmodic Torticollis Rating Scale and the Clinical Global Impression Scale-jerks/tremor subscale were used to score motor severity and to assess whether motor characteristics could explain an additional part of the variation in fatigue and sleep-related measures. HR-QoL was determined with the RAND-36 item Health Survey, and predictors of HR-QoL were assessed using multiple regression.ResultsFatigue scores were increased independently from psychiatric comorbidity (4.0 vs. 2.7; P < 0.01), whereas EDS (7.3 vs. 7.4; P = 0.95) and sleep quality (6.5 vs. 6.1; P = 0.73) were highly associated with depression and anxiety. In patients with CD, motor severity did not explain the variations in fatigue (change in the correlation coefficient [ΔR2] = 0.06; P = 0.15), EDS (ΔR2 = 0.00; P = 0.96), or sleep quality (ΔR2 = 0.04; P = 0.38) scores. Fatigue, EDS, psychiatric comorbidity, and pain predicted a decreased QoL.ConclusionIndependent from psychiatric comorbidity and motor severity, fatigue appeared to be a primary NMS. Sleep-related measures were highly associated with psychiatric comorbidity, but not with motor severity. Only NMS predicted HR-QoL, which emphasizes the importance of attention to NMS in patients with CD.

Dataset Information

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

Publications

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

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