Efficacy of Suvorexant on Post-operative Sleep Disturbance
Postoperative Insomnia, Postoperative Delirium
About this trial
This is an interventional treatment trial for Postoperative Insomnia focused on measuring Sleep Disturbance, Insomnia, Sleep quality, Suvorexant
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. 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).
Sites / Locations
- Columbia University Irving Medical Center/NewYork-Presbyterian Milstein Hospital/New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Suvorexant administration
Placebo administration
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). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).