The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.
Restless Legs Syndrome (RLS) is a sensory-motor neurological disorder characterized by an irresistible urge to move the legs. Persistent difficulties with all phases of sleep are common in patients whose RLS symptoms are resolved with treatment. Multiple potential causes for treatment-refractory sleep disturbance exist, including activating effects of dopamine agonists (which are first-line RLS treatments), conditioned insomnia and poor sleep habits as a result of chronic RLS-related sleep disturbance, and comorbid medical and psychiatric illness. Suvorexant provides an important therapeutic option to treat insomnia in the context of RLS. It has demonstrated long-term efficacy, particularly in shortening the duration of nocturnal awakenings and increasing total sleep time. Similarly, it has a comparatively benign side effect profile compared to many other agents typically prescribed to treat insomnia. The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time, as well as actigraphically-derived wake after sleep onset, Insomnia Severity Index score, subjective sleep endpoints, and RLS symptom severity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
10-mg or 20-mg suvorexant capsules
Matching placebo capsules
Massachusetts General Hospital
Boston, Massachusetts, United States
Actigraphically-Derived Total Sleep Time
Change in mean total sleep time (between baseline and end of treatment, for each treatment period), as measured by actigraphy. Participants wear an actigraph watch, which assesses periods of activity and rest to determine the total amount of sleep during one sleep period. Total sleep time excludes sleep onset latency and nighttime awakenings.
Time frame: 2 weeks
Actigraphically-Derived Wake After Sleep Onset
Change in wake after sleep onset (between baseline and end of treatment, for each treatment period), as measured by actigraphy. Participants wear an actigraph watch, which assesses periods of activity and rest to determine the total wake time after sleep onset, during nighttime awakenings.
Time frame: 2 weeks
Insomnia Severity Index
Change in ISI score between baseline and end of treatment, for each treatment period. The ISI is a validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity.
Time frame: 2 weeks
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