Efficacy of Suvorexant on Post-operative Sleep Disturbance

Description

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.

Conditions

Postoperative Insomnia, Postoperative Delirium

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Study Overview

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Study Details

Study overview

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.

Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration

Efficacy of Suvorexant on Post-operative Sleep Disturbance

Condition
Postoperative Insomnia
Intervention / Treatment

-

Contacts and Locations

New York

NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building, New York, New York, United States, 10032/10034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

50 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Paul S. Garcia, MD PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2025-05