Can a nighttime sleep pill cut painkiller use after knee surgery?

NCT ID NCT07801742

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether zolpidem, a common sleep medication, can improve sleep quality and reduce painkiller use in adults recovering from total knee replacement. Half of the participants take zolpidem 10 mg each night for two weeks after leaving the hospital, while the other half take a placebo. Neither the patients nor their doctors know which treatment they receive. Researchers measure pain intensity, sleep quality, pain medication use, and recovery to see if better sleep leads to better outcomes.

What this could mean

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

Active substance
zolpidem, a sleep medication, taken as 10 mg tablets nightly for 14 nights after knee replacement surgery
What this could lead to
If it works, zolpidem could help people sleep better and use fewer painkillers after knee replacement surgery, potentially speeding recovery.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. Zolpidem can cause side effects like drowsiness or dizziness, and improving sleep may not reduce pain or opioid use.

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

54 people

The number who actually took part.

Started

Aug 2025

Finished

Jun 2026

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

18 years and older

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: * Age ≥18 years. * Undergoing primary total knee arthroplasty (TKA). * Ability to understand the study procedures. * Ability to provide written informed consent. * Ability to complete the postoperative questionnaires. Exclusion Criteria: * History of hypersensitivity to zolpidem or other hypnotic agents. * Revision total knee arthroplasty. * Arthroplasty performed for fracture. * Preoperative use of sleep medications. * Obstructive sleep apnea. * Severe respiratory insufficiency. * Severe hepatic disease. * Cognitive impairment preventing reliable assessment.

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Conditions

The condition(s) this trial relates to.

insomnia Pain, Postoperative

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sanatorio Allende

    Córdoba, Córdoba Province, 5000, Argentina

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