Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Condition: Sleep Disorder, Shift-Work
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Intervention: Suvorexant; Placebo
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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