Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

  • End date
    Jun 9, 2023
  • participants needed
  • sponsor
    Massachusetts General Hospital
Updated on 9 September 2021
total sleep time
wake after sleep onset
chronic insomnia
restless legs syndrome


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.

Condition Restless Legs Syndrome, restless leg, sleep disorder, Sleep Disorders, Restless Leg Syndrome, Neurologic Disorders, nervous system disorder, Sleep Disorders (Pediatric), Insomnia
Treatment Placebo, Suvorexant
Clinical Study IdentifierNCT04706091
SponsorMassachusetts General Hospital
Last Modified on9 September 2021


Yes No Not Sure

Inclusion Criteria

Men or women of any ethnic origin
Written informed consent is obtained
Speaks and writes in English
A willingness and ability to comply with study procedures
Age 25-85 years
Diagnosis of RLS via Cambridge-Hopkins RLS questionnaire
International Restless Legs Syndrome Study Group scale score (IRLS) < 15
RLS treatment with a dopaminergic agonist or an alpha-2-delta agent
No changes in RLS medication in the previous month
DSM-5 criteria for Insomnia Disorder
Report a total sleep time 7 hours and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit

Exclusion Criteria

Diagnosis of moderate/severe obstructive sleep apnea (AHI > 30) not using continuous positive airway pressure therapy (CPAP) (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy)
Shift workers
Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
Unwillingness to maintain stable RLS medication during the study unless medically indicated
Current use of an opiate medication
Unwillingness to not take stimulants (e.g. caffeine) after 4:00 pm during the study
Current major depressive episode, by report and as indicated by the Patient Health Questionnaire (PHQ-9)
Lifetime history of bipolar disorder, psychosis, or other serious psychiatric illness
Current alcohol/substance use disorder
BMI 40 kg/m^2
Renal or hepatic disease judged to interfere with drug metabolism and excretion
Pregnancy or breastfeeding
Malignancy within past 2 years
Surgery within past 3 months
Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment
Medical instability considered to interfere with study procedures
Concomitant medications with drug interaction or co-administration concerns
Contraindications or allergic responses to suvorexant
History of being treated with suvorexant
Travel across two time-zones during the week prior to enrollment
Greater than 6 cups of coffee per day
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