Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight shifts will significantly improve both objective (total sleep time, sleep efficiency, wake after sleep onset) and subjective (sleep quality) measures of daytime sleep.

Conditions
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Sleep Disorder, Shift-Work

Intervention / Treatment
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* Drug: Suvorexant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling) Males and females Shift worker Minimum of three months of prior shift work Will work minimum of four nights per week or 32 hours of night shift per week during study Night work defined as having at least six hours of work occurring between 8 PM and 8 AM and no longer than 12 hours on shift Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type Insomnia (SE < 88%) during attempted daytime sleep or excessive sleepiness during nocturnal wake Exclusion Criteria: Currently or planning to become pregnant Currently breastfeeding Inadequate opportunity (<7 hours) for daytime sleep after shift work Use of sleep aids during the study period. Includes as needed or continuous use of prescription, non-prescription, and naturopathic pharmacotherapies Diagnosis or detection (during study) of sleep disordered breathing (AHI>10) on home sleep testing; referral to clinical sleep program will be offered Diagnosis of narcolepsy Restless Legs Syndrome >600 mg caffeine intake per night shift or use of prescription stimulant medication during night shift Rotational or irregular work shifts during study Use of digoxin for six months prior to or during study Use of strong (e.g., etoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) or moderate (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) CYP3A inhibitors or CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin) for six months prior to or during study Severe hepatic impairment Unstable or severe medical or psychiatric condition

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>10 mg of suvorexant 30 minutes prior to daytime sleep opportunity | Drug: Suvorexant<br> <br> * Other names: Belsomra;|
| Placebo Comparator: Placebo<br>Placebo pill 30 minutes prior to daytime sleep opportunity | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Total Sleep Time | Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline | Daytime sleep will be examined from baseline to after 3 weeks |