Efficacy of Suvorexant on Post-operative Sleep Disturbance

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Suvorexant

Criteria

Inclusion criteria:

• 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 criteria:

• Patients who undergo surgery and then are admitted to intensive care.

• Coronary artery bypass graft (CABG) or other cardiac surgeries.

• Intra-cranial surgery.

• Chronic pain (i.e., patients on opioid medications as an outpatient).

• Circadian rhythm disorders.

• High Beck Depression or Beck Anxiety scores.

• Moderate to severe dementia (failed 3D CAM)

• 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, non-English speaking patients).