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New insomnia pill shows promise in Late-Stage trial

NCT ID NCT07028697

Symptom relief Sponsor: Nxera Pharma Korea Co., Ltd. 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new sleep medication called daridorexant in 164 adults and elderly people with insomnia. Participants received either the drug or a placebo for 4 weeks. Researchers measured changes in total sleep time, how fast they fell asleep, and time awake after sleep onset. The goal was to see if the drug improves sleep quality and safety compared to a placebo.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

164 people

The number who actually took part.

Started

Dec 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 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: * Signed informed consent prior to any study-mandated procedure; * Male or female aged ≥ 19 years; * Insomnia disorder according to DSM-5 criteria; * The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms: * Difficulty initiating sleep. * Difficulty maintaining sleep (characterized by frequent awakenings or problems returning to sleep after awakenings). * Early-morning awakening with inability to return to sleep. * Insomnia Severity Index score ≥ 15; * Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h Exclusion Criteria: * Body mass index (BMI) ≥ 40.0 kg/m2 * Documented medical history and/or comorbidity of sleep-related breathing disorder * History of and/or concurrent sleep apnea or suspected sleep apnea * Korean-Mini Mental State Examination-2 (K-MMSE-2) score \< 25 in subjects ≥ 50 years; * For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period * Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study * A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C) * Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.

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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 disorder

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Catholic Kwandong University International St. Mary'S Hospital

    Incheon, 22711, South Korea

  • Chonnam National University Hospital

    Gwangju, 61469, South Korea

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Ewha Womans University Medical Center

    Seoul, 07804, South Korea

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Inje University Ilsan Paik Hospital

    Ilsan, 10380, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, 42601, South Korea

  • Kyung Hee University Hospital At Gangdong

    Seoul, 05278, South Korea

  • Pusan National University Yangsan Hospital

    Busan, 50612, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151, South Korea

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon, 16247, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

More trials for these conditions

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