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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder, Shift-Work
• Intervention / Treatment: Drug: Placebo; Drug: Suvorexant

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug; 10 mg of suvorexant 30 minutes prior to daytime sleep opportunity	Drug: Suvorexant; Other Names: Belsomra
Placebo Comparator: Placebo; Placebo pill 30 minutes prior to daytime sleep opportunity	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Total Sleep Time	Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline	Daytime sleep will be examined from baseline to after 3 weeks

Collaborators and Investigators

• Sponsor: VA Palo Alto Health Care System
• Collaborators: Merck Sharp & Dohme LLC; Stanford University

Publications and helpful links

General Publications

• Zeitzer JM, Joyce DS, McBean A, Quevedo YL, Hernandez B, Holty JE. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Suvorexant
• Other Study ID Numbers: IRB-34778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All relevant data will be provided in the publication