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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2019-08-01

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.

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Detailed Description

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Conditions

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Sleep Disorder, Shift-Work

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Drug

10 mg of suvorexant 30 minutes prior to daytime sleep opportunity

Group Type EXPERIMENTAL

Suvorexant

Intervention Type DRUG

Placebo

Placebo pill 30 minutes prior to daytime sleep opportunity

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Suvorexant

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Belsomra

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes