NCT02491788

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

Completed Phase 4 Results posted Last updated 1 July 2020

What this trial tests

Phase 4 trial testing Suvorexant in Sleep Disorder, Shift-Work in 19 participants. Completed in 1 August 2019.

Timeline

1 February 2016

Primary endpoint
1 August 2019

1 August 2019

Quick facts

Lead sponsor	VA Palo Alto Health Care System
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	19
Start date	1 February 2016
Primary completion	1 August 2019
Estimated completion	1 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Suvorexant — full drug profile →
• Placebo

Conditions studied

• Sleep Disorder, Shift-Work — all drugs for Sleep Disorder, Shift-Work →

Sponsor

VA Palo Alto Health Care System

Who can join

Adults 20 to 60, any sex, with Sleep Disorder, Shift-Work. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Average Total Sleep Time Primary · Daytime sleep will be examined from baseline to after 3 weeks

Change in average of the total amount of sleep occurring during daytime sleep episodes following night shift work, as compared to baseline

Group	Value	95% CI
Drug	1.83	± 0.62
Placebo	-0.33	± 0.49

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Drug

Serious: 0/8 (0%)

Deaths: 0/8

Placebo

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (2 terms — click to expand)

Reaction	System	Drug	Placebo
Facial swelling	Musculoskeletal and connective tissue disorders	—	—
Fatigue	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02491788 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circadian rhythm as a therapeutic target.
   Ruan W, Yuan X, Eltzschig HK. · · 2021 · cited 331× · PMID 33589815 · DOI 10.1038/s41573-020-00109-w
2. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial.
   Zeitzer JM, Joyce DS, McBean A, Quevedo YL, et al · · 2020 · cited 16× · PMID 32484552 · DOI 10.1001/jamanetworkopen.2020.6614