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Efficacy of Suvorexant on Post-operative Sleep Disturbance

CompletedPhase 4

Sponsor: Columbia University

Conditions: Postoperative Insomnia, Postoperative Delirium

Interventions: Suvorexant, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 50 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
* 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).

Locations (1)

New York, New York, United States