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Can a sedative quiet the Brain's alarm system in insomnia?

NCT ID NCT07392177

Knowledge-focused Sponsor: Woolcock Institute of Medical Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This pilot study will test whether a drug called dexmedetomidine can reduce activity in a brain region (the locus coeruleus) that may be too active during sleep in people with insomnia. Fifteen adults with insomnia will receive either the drug or a placebo before bed in a crossover design. The goal is not to treat insomnia directly but to understand the brain mechanisms behind it.

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 as a buccal tablet)
What this could lead to
If successful, this could point toward a new way to treat insomnia by calming overactive brain circuits during sleep.
What could go wrong
This is a very small pilot study (15 people) testing a drug not yet approved for insomnia. It may not show clear benefits or could cause side effects like low blood pressure or drowsiness.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

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

Started

Aug 2026

Expected to finish

Mar 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

30 to 65 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: * Diagnosis of insomnia disorder (DSM-5-TR) * Insomnia severity index (ISI) score ≥15 * Able to provide informed consent * Fluent English literacy Exclusion Criteria: * Medically diagnosis of sleep disordered breathing (i.e. sleep apnea) or sleep or circadian disorder other than insomnia * Uncontrolled psychiatric disorders * High dependence on medical care * History of, or current suicide ideation (Patient Health Questionnaire (PHQ-9) questionnaire) * Pregnancy or actively trying to conceive, or lactating * Shiftwork - defined as work outside of business hours (before 8am or after 6pm) conducted at least once per week * Travel across time zones of over 2 h time difference in the past week * Contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures * Concomitant use of medicines that are inhibitors, or moderate to strong inducers, of CYP3A4; regular use of hypnotics and other medications that can cause additive sedation or psychostimulants or non-amphetamine psychostimulants within 14 days of starting the clinical trial * Ongoing use of THC- or CBD-containing products; dependence or any other drug or alcohol dependence * Allergy to lactose

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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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Woolcock Institute of Medical Research

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

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