Clinical trial NCT02491788: Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disorder, Shift-Work
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Merck Sharp & Dohme LLC
name: Stanford University
First posted: 2015-07-08
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \< 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

Primary outcomes:
measure: Change in Average Total Sleep Time
timeFrame: Daytime sleep will be examined from baseline to after 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
citation: 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.