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Efficacy of Suvorexant on Post-operative Sleep Disturbance
Sponsor: Columbia University
Summary
The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). The other control group of 46 subjects will receive placebo (two tablets) and treatment as usual.
Official title: Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2023-05-01
Completion Date
2025-05
Last Updated
2024-05-22
Healthy Volunteers
No
Interventions
Suvorexant
Suvorexant (Belsomra™) is an orexin receptor antagonist that will be administered as 2 tablets (10mg each) for a starting dose of 20mg. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant.
Placebo
The placebo pill will look identical to Suvorexant and will be taken as 2 tablets.
Locations (1)
NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building
New York, New York, United States