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InsomniaPhase 4NCT04742699

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

A Phase 4 study testing Lemborexant (LEM) 5 mg (Z-Drug-mono cohort), Lemborexant (LEM) 5 mg (SUV-mono cohort) and Lemborexant (LEM) 5 mg (SUV-combination cohort) in people with Insomnia, run by Kurume University at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current medication. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Insomnia
What is being tested?
Lemborexant (LEM) 5 mg (Z-Drug-mono cohort), Lemborexant (LEM) 5 mg (SUV-mono cohort) and Lemborexant (LEM) 5 mg (SUV-combination cohort)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
9 sitesJapan
Study dates
24 Mar 2021to 20 Jun 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have voluntarily provided a written informed consent to participate in the study
  • Subjects with insomnia aged 20 years or older at the time of informed consent
  • Subjects who are dissatisfied with the efficacy or tolerability of prior medications and wish to transition from them. For example;
  • Subjects who are treated with Z-Drug monotherapy or a combination of BZRA and RMT, and have particularly difficulties with sleep maintenance
  • Subjects who are treated with SUV monotherapy or a combination of BZRA and SUV, and have particularly difficulties with sleep onset
  • Subjects who are treated with a combination therapy of BZRA and SUV or BZRA and RMT, and wish to reduce or discontinue BZRA
Show all 15Show fewer
  • Subjects with frequent use (i.e. at least 5 nights a week) of Z-drug monotherapy, SUV monotherapy, combination therapy with BZRA and SUV, or combination therapy with BZRA and RMT in the month before the start of the pretreatment phase.
  • Subjects who meet the criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) as follows
  • Despite an adequate opportunity for sleep, subjects have night sleep-related complaints accompanied by at least 1 of the following symptoms: difficulty in falling asleep, difficulty in staying asleep, and waking up early
  • The difficulty in sleeping occurs at least 3 nights a week
  • The difficulty in sleeping persists for at least 3 months
  • The difficulty in sleeping causes daytime dysfunction
  • Subjects who can secure at least 7 hours for sleep
  • Subjects who have a documented use of a prior medication(s) for the treatment of insomnia at least 5 nights in the last 2 weeks of the pretreatment phase
  • Subjects who are able to comply with the requirements specified in the study protocol

Who cannot join

  • Female who are breastfeeding or pregnant at pretreatment phase. If pregnancy cannot be completely denied by interview, a serum beta-hCG test will be performed.
  • Females of childbearing potential who did not use a highly effective method of contraception, which includes:
  • total abstinence (if it is their preferred and usual lifestyle)
  • use of condom
  • an intrauterine device (IUD)
  • a contraceptive implant
Show all 34Show fewer
  • an oral or an injective contraceptive
  • have a vasectomized partner with confirmed azoospermia; The following methods are not considered as contraception: periodic abstinence such as calendar method, ovulation method, symptothermal method, basal body temperature method, and withdrawal method.
  • Do not agree to use a highly effective method of contraception (as described above)
  • Subjects with moderate or severe obstructive sleep apnea (OSA).
  • Subjects with any symptoms and/or disease that may affect the safety or the endpoints of the study in the opinion of the investigator (see the examples below)
  • Cardiac disorder [including subjects with repeated QT interval prolongation*1 in previous ECG tests. For subjects whose QT interval abnormality cannot be ruled out by interview, ECG tests should be performed by baseline (Visit 2) to confirm the normality of corrected QT (QTc) interval].
  • 1: QT interval corrected by Fridericia's formulas (QTcF) exceeds 450 ms
  • Respiratory disorder other than mild OSA
  • Digestive disease
  • Kidney disease [including renal dysfunction]
  • Neurological disorders [including intellectual incapacity or cognitive decline with disorientation to the person, place, time or situation]
  • Mental disorders
  • Chronic pain [pain disorders]
  • Carcinoma within 5 years [excluding appropriately treated basal cell carcinoma]
  • Subjects who currently have certain sleep disorders other than insomnia such as periodic limb movement disorder, restless legs syndrome, and circadian rhythm sleep disorder. Subjects diagnosed with mild OSA are not excluded from the study
  • Subjects who currently have a habit of napping for a long period of time 3 or more times a week in the opinion of the investigator.
  • Subjects who currently have narcolepsy or cataplexy
  • Subjects who are using a prior medication(s) for the treatment of insomnia at doses exceeding the dosage and administration approved in Japan
  • Subjects who are using two or more BZRAs
  • Subjects who are using sedative medication(s)
  • Have used prohibited concomitant drugs within 1 week before the start of the pretreatment phase
  • Have newly started nonpharmacologic treatments for insomnia (eg, cognitive behavioral therapy) within 1 week before the pretreatment phase
  • Subjects who cannot refrain from excessive alcohol consumption during study participation
  • Subjects with a history of hypersensitivity to any of the excipients of LEM
  • Subjects with moderate or severe hepatic impairment (subjects whose AST, ALT, or gamma-GTP is 3 times or more the upper limit of the institutional reference interval)
  • History of antipsychotic drugs use within the past 2 years or attempted suicide, which may affect the safety or the endpoints of the study in the opinion of the investigator
  • Subjects who have previously taken LEM (including subjects who have participated in a clinical trial of LEM)
  • Subjects deemed inappropriate to participate in this study in the opinion of the investigator

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Kotorii Isahaya Hospital

    Isahaya, Nagasaki, 854-0081

  • YOU ARIYOSHI Sleep Clinic

    Kitakyushu, Fukuoka, 802-0084

  • Kuwamizu Hospital

    Kumamoto, 862-0954

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Hirota Clinic

    Kurume, Fukuoka, 830-0033

  • Kurume University Medical Center

    Kurume, Fukuoka, 839-0863

  • Ohshima Hospital

    Nakatsukuma, Saga-ken, 849-0111

  • Sleep Support Clinic

    Shinagawa, Tokyo, 140-0011

  • Sleep & Stress Clinic

    Shinagawa, Tokyo, 141-6003

Other trials in Japan

About this study

This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current medication.

Transition from Following 4 regimens of interest will be investigated; Z-Drug monotherapy, suvorexant (SUV) monotherapy, SUV and benzodiazepine receptor agonists (BZRA) combination therapy, and ramelteon (RMT) and BZRA combination therapy. Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled.

As a comprehensive indicator of patient satisfaction including treatment efficacy and safety, the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning; thus important initial response after transitioning will be evaluated as a primary endpoint. In addition, as a secondary purpose, the treatment continuation, efficacy and tolerability, and the treatment impression for insomnia (Patient Global Impression of Insomnia) for 14 weeks after transitioning will be assessed.

Conditions
Insomnia
Being tested
Lemborexant (LEM) 5 mg (Z-Drug-mono cohort), Lemborexant (LEM) 5 mg (SUV-mono cohort), Lemborexant (LEM) 5 mg (SUV-combination cohort), Lemborexant (LEM) 5 mg (RMT-combination cohort)
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)Drug

    1. Pretreatment phase: Continue pre-registration treatment (Z-drug monotherapy) without LEM.
    2. First treatment phase: Administer LEM 5 mg/day as a substitute for Z-Drug. Increasing LEM dose to 10 mg/day is allowed.
    3. Maintenance phase: Succeed the treatment from the first treatment phase. Changing LEM dose is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.

  • Lemborexant (LEM) 5 mg (SUV-mono cohort)Drug

    1. Pretreatment phase: Continue pre-registration treatment (SUV monotherapy) without LEM.
    2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV. Increasing to LEM dose to 10 mg/day is allowed.
    3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed.

  • Lemborexant (LEM) 5 mg (SUV-combination cohort)Drug

    1. Pretreatment phase: Continue pre-registration treatment (SUV and BZRA combination therapy) without LEM.
    2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.
    3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.

  • Lemborexant (LEM) 5 mg (RMT-combination cohort)Drug

    1. Pretreatment phase: Continue pre-registration treatment (RMT and BZRA combination therapy) without LEM.
    2. First treatment phase: Administer LEM 5 mg/day as a substitute for RMT and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.
    3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition.
Study groups in NCT04742699
Study groupRoleWhat they receive
Z-Drug-mono cohortExperimentalPatients being treated with Z-drug monotherapy at registration
Receives: Drug: Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)
SUV-mono cohortExperimentalPatients being treated with SUV monotherapy at registration
Receives: Drug: Lemborexant (LEM) 5 mg (SUV-mono cohort)
SUV-combination cohortExperimentalPatients being treated with SUV and BZRA combination therapy at registration
Receives: Drug: Lemborexant (LEM) 5 mg (SUV-combination cohort)
RMT-combination cohortExperimentalPatients being treated with RMT and BZRA combination therapy at registration
Receives: Drug: Lemborexant (LEM) 5 mg (RMT-combination cohort)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with successful LEM treatment at the end of the first treatment phase to the patients who started the first treatment phase.

    The primary endpoint is the proportion of patients with successful LEM treatment at the end of the first treatment phase to the patients who started the first treatment phase. Evaluation is performed for each treatment group.

    Successful LEM treatment at the end of the first treatment phase is primarily defined as follows;

    • Patients who wish to continue LEM treatment at the end of the first treatment phase and actually move on to the maintenance phase
    • Patients who wish to continue LEM treatment at the end of the first treatment phase but do not move to the maintenance phase with a reason not related to the efficacy or safety of LEM treatment (e.g., relocation, clinic transfer, or a burden of site visit expenses)

    Measured: 2 weeks

Secondary outcomes (4)

  1. Proportion of patients who continued LEM treatment and those who continued LEM monotherapy at the end of the first treatment phase and the maintenance phase.

    Measured: 2 - 14 weeks

  2. Proportion of patients with an itemized positive response on the PGI-I at baseline, the end of the first treatment phase, and the end of the maintenance phase.

    Measured: 2 - 14 weeks

  3. Proportion of patients with increased LEM dosage at the end of the first treatment phase and at the end of the maintenance phase.

    Measured: 2 - 14 weeks

  4. Occurrence of adverse events during the first treatment phase and the maintenance phase.

    Measured: 2 - 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start24 Mar 2021
  3. Primary completion20 Jun 2022
  4. Study completion20 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742699
Sponsor's protocol ID
E2006-M081-401
Status last verified
Mar 2023
First submitted
3 Feb 2021
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ozone M, Hirota S, Ariyoshi Y, Hayashida K, Ikegami A, Habukawa M, Ohshima H, Harada D, Hiejima H, Kotorii N, Murotani K, Nishi Y, Koebis M, Taninaga T, Uchimura N. Self-reported sleep variables, sleep quality, and quality of life assessment in transition to lemborexant in patients with Insomnia: the multicenter, open-label SOMNUS study. Sleep Med X. 2025 Sep 25;10:100149. doi: 10.1016/j.sleepx.2025.100149. eCollection 2025 Dec 15.

    PubMed 41103818

  • Ozone M, Hirota S, Ariyoshi Y, Hayashida K, Ikegami A, Habukawa M, Ohshima H, Harada D, Hiejima H, Kotorii N, Murotani K, Taninaga T, Uchimura N. Efficacy and Safety of Transitioning to Lemborexant from Z-drug, Suvorexant, and Ramelteon in Japanese Insomnia Patients: An Open-label, Multicenter Study. Adv Ther. 2024 Apr;41(4):1728-1745. doi: 10.1007/s12325-024-02811-2. Epub 2024 Mar 9.

    PubMed 38460107

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lemborexant (LEM) 5 mg (Z-Drug-mono cohort), Lemborexant (LEM) 5 mg (SUV-mono cohort) and Lemborexant (LEM) 5 mg (SUV-combination cohort) in people with Insomnia, run by Kurume University at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with successful LEM treatment at the end of the first treatment phase to the patients who started the first treatment phase. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742699, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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