Efficacy of Suvorexant on Post-operative Sleep Disturbance
Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
Columbia University
92 participants
May 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Aged 50 years to 90 years old.
- Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer), urologic or gynecologic surgery, and spine surgery with a projected inpatient stay of 24 hours or longer.
- Patients experiencing insomnia characterized by difficulties with sleep onset, early morning awakening, and/or sleep maintenance three or more times weekly over a three-month period for eligibility.
Exclusion Criteria10
- Patients who undergo surgery and then are admitted to intensive care.
- Coronary artery bypass graft (CABG) or other cardiac surgeries.
- Intra-cranial surgery.
- Patients taking more than 60 mg of oxycodone or it's equivalent as outpatient
- Circadian rhythm disorders.
- High score in the Geriatric Depression Scale (GDS)
- Moderate to severe dementia (failed t-MoCa)
- Severe obstructive sleep apnea (OSA) (Apnea-hypopnea index (AHI)>30 and/or screen high risk)
- Patients receiving Cytochrome P-450 (CYP3) inhibitors or inducers (Inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Inducers: phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids).
- Vulnerable populations (i.e., children, pregnant women).
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Interventions
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.
The placebo pill will look identical to Suvorexant and will be taken as 2 tablets.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05823844