Phase 4 N=19 Randomized Triple-blind Treatment

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

Sleep Disorder, Shift-Work

Bottom Line

View on ClinicalTrials.gov: NCT02491788 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Suvorexant (Drug); Placebo (Drug)
Age: Adult · 20+ yrs
Sex: All
Sponsor: VA Palo Alto Health Care System
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average Total Sleep Time	1.83; -0.33	<0.05 sig

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02491788). 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.