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Could a sleep drug fix chronic insomnia? new trial aims to find out

NCT ID NCT07255027

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a drug called dexmedetomidine, given through an IV to induce sleep, can help people with severe insomnia that hasn't improved with other treatments. 180 adults aged 18-65 will receive either the drug plus standard oral medication or standard medication alone. The goal is to see if this approach improves deep sleep and provides lasting relief.

What this could mean

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

Active substance
Dexmedetomidine (a sedative drug given intravenously) plus standard oral sleep medication
What this could lead to
If it works, this could offer a new treatment option for people with severe, hard-to-treat insomnia that hasn't improved with standard therapies.
What could go wrong
This is an early-stage study with only 180 participants, so results may not apply to everyone. The treatment involves sedation and carries risks like low blood pressure or slow heart rate, and long-term benefits are still unclear.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

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 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adults aged 18-65 years meeting ICSD-3 diagnostic criteria for chronic insomnia. * Persistent sleep disturbance (≥3 nights/week for ≥3 months). * Significant daytime impairment (e.g., mood disturbance, cognitive decline). * Treatment-refractory (failed prior pharmacotherapy/non-pharmacotherapy). * No chronic obstructive pulmonary disease, moderate to severe sleep apnea syndrome, or atrioventricular block. * Obtain written informed consent. Exclusion Criteria: * Participants with severe concomitant diseases affecting other organ systems. * Moderate to severe obstructive sleep apnea (e.g., AHI ≥30 events/hour) or uncontrolled central sleep apnea. * Pregnant, lactating, or planning pregnancy. * History of alcoholism or drug dependence. * Suicidal ideation or a severe psychiatric history (e.g., schizophrenia, unstable bipolar disorder). * Participants with a prior allergic reaction to the study drug. * Participants who have recently participated in other clinical studies.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

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

Insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.