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

VA Palo Alto Health Care System

Status and phase

Completed

Phase 4

Conditions

Sleep Disorder, Shift-Work

Treatments

Drug: Placebo

Drug: Suvorexant

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Industry

Identifiers

NCT02491788

IRB-34778

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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