Phase 4
Completed N=19
Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Sleep Disorder, Shift-Work
Source: ClinicalTrials.gov NCT02491788 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05
◆ Published Evidence
Established
28citations · ~5 / year
Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial.
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.
Linked Publications
-
Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Total Sleep Time |
1.83; -0.33 | <0.05 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT02491788) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.