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Sleeping pill may help older adults recover better after surgery

NCT ID NCT05823844

Symptom relief Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether the sleep medication suvorexant can improve restorative sleep and reduce insomnia in older adults recovering from elective surgery. Participants aged 50 to 90 who have a history of insomnia will receive either suvorexant or a placebo during their hospital stay. The study measures total sleep time and tracks sleep patterns over several days to see if the drug helps restore normal sleep after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a sleep medication called suvorexant (Belsomra), an orexin receptor antagonist
What this could lead to
If it works, this could point toward a way to improve sleep quality and reduce insomnia after surgery in older adults.
What could go wrong
This is a relatively small, early-phase trial, so results may not apply to everyone. The medication may cause daytime sleepiness or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

100 people

The number who actually took part.

Started

May 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Emergence Delirium insomnia Parasomnias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative delirium Postoperative insomnia

Contacts and locations

Locations

  • NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building

    New York, New York, 10032/10034, United States

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