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Lemborexant

FDA-approved product (tablet, oral), marketed as Dayvigo.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Lemborexant
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Insomnia

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Orexin receptor antagonists
FDA pharmacologic class
Orexin Receptor Antagonist FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against E. coli, MRSA and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA58.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli43.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae24.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis64.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.7 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.7 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.1 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.2 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Lemborexant with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)

    NCT06843187 · start 2024-09-25

    Registered record
    Registry ID
    NCT06843187
    Conditions
    Major Depressive Disorder(MDD); Insomnia Comorbid to Psychiatric Disorder
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2024-09-25
    Completion
    2026-07-15
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMajor Depressive Disorder(MDD); Insomnia Comorbid to Psychiatric Disorder
    InterventionLemborexant; Placebo
    PhasePhase 2
    Registry statusTerminated
  • Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

    NCT06496282 · start 2024-08

    Registered record
    Registry ID
    NCT06496282
    Conditions
    Sleep
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2024-08
    Completion
    2026-07
    Enrolment
    50

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSleep
    InterventionLemborexant; Placebo
    PhasePhase 3
    Registry statusUnknown
  • DORA and LP in Alzheimer's Disease Biomarkers

    NCT06274528 · start 2024-03-11

    Registered record
    Registry ID
    NCT06274528
    Conditions
    Alzheimer Disease
    Interventions
    Lemborexant 10 mg; Lemborexant 20mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-03-11
    Completion
    2030-03-31
    Enrolment
    201

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAlzheimer Disease
    InterventionLemborexant 10 mg; Lemborexant 20mg; Placebo
    PhasePhase 2
    Registry statusRecruiting
  • Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

    NCT06225947 · start 2024-02-22

    Registered record
    Registry ID
    NCT06225947
    Conditions
    Insomnia
    Interventions
    Lemborexant 5 MG
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2024-02-22
    Completion
    2025-06-30
    Enrolment
    200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInsomnia
    InterventionLemborexant 5 MG
    PhaseNot recorded
    Registry statusUnknown
  • The Effects of Lemborexant on the Ability to Sleep During Daytime

    NCT06231641 · start 2024-01-11

    Registered record
    Registry ID
    NCT06231641
    Conditions
    Shift-Work Sleep Disorder
    Interventions
    Lemborexant 5 MG [Dayvigo]; Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2024-01-11
    Completion
    2026-03-31
    Enrolment
    5

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionShift-Work Sleep Disorder
    InterventionLemborexant 5 MG [Dayvigo]; Matching Placebo
    PhasePhase 2
    Registry statusTerminated
  • Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

    NCT06093126 · start 2023-12-11

    Registered record
    Registry ID
    NCT06093126
    Conditions
    Insomnia; Dementia; Frontotemporal Dementia
    Interventions
    Lemborexant 5 MG
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2023-12-11
    Completion
    2028-12-11
    Enrolment
    1

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInsomnia; Dementia; Frontotemporal Dementia
    InterventionLemborexant 5 MG
    PhasePhase 4
    Registry statusRecruiting
  • Lemborexant in Delayed Sleep Phase Syndrome

    NCT06874855 · start 2023-03-13

    Registered record
    Registry ID
    NCT06874855
    Conditions
    Delayed Sleep Phase Syndrome
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2023-03-13
    Completion
    2027-05-31
    Enrolment
    15

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDelayed Sleep Phase Syndrome
    InterventionLemborexant; Placebo
    PhasePhase 4
    Registry statusRecruiting
  • Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

    NCT05728736 · start 2023-03-01

    Registered record
    Registry ID
    NCT05728736
    Conditions
    Alzheimer Disease
    Interventions
    Lemborexant 25 mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2023-03-01
    Completion
    2023-10-04
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAlzheimer Disease
    InterventionLemborexant 25 mg; Placebo
    PhasePhase 2
    Registry statusWithdrawn
  • Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

    NCT05458609 · start 2023-02-09

    Registered record
    Registry ID
    NCT05458609
    Conditions
    Alcohol Use Disorder
    Interventions
    Lemborexant 10 mg; Naltrexone
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-02-09
    Completion
    2024-01-30
    Enrolment
    8

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAlcohol Use Disorder
    InterventionLemborexant 10 mg; Naltrexone
    PhasePhase 3
    Registry statusCompleted
  • Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold

    NCT05763329 · start 2023-02-01

    Registered record
    Registry ID
    NCT05763329
    Conditions
    OSA
    Interventions
    Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1; Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2; Placebo Day 1; Placebo Day 2
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2023-02-01
    Completion
    2025-06-30
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionOSA
    InterventionLemborexant 5 MG Oral Tablet [Dayvigo] Day 1; Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2; Placebo Day 1; Placebo Day 2
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

    NCT05594589 · start 2022-11-30

    Registered record
    Registry ID
    NCT05594589
    Conditions
    Sleep Initiation and Maintenance Disorders
    Interventions
    Lemborexant; PBO
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-11-30
    Completion
    2024-05-24
    Enrolment
    65

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSleep Initiation and Maintenance Disorders
    InterventionLemborexant; PBO
    PhasePhase 2
    Registry statusCompleted
  • Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

    NCT05618002 · start 2022-11-08

    Registered record
    Registry ID
    NCT05618002
    Conditions
    Chronic Insomnia; Chronic Pain
    Interventions
    Lemborexant
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2022-11-08
    Completion
    2025-12-11
    Enrolment
    150

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionChronic Insomnia; Chronic Pain
    InterventionLemborexant
    PhaseNot recorded
    Registry statusRecruiting
  • Lemborexant Shift Work Treatment Study

    NCT05344443 · start 2022-03-10

    Registered record
    Registry ID
    NCT05344443
    Conditions
    Shift-Work Related Sleep Disturbance
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2022-03-10
    Completion
    2024-11-30
    Enrolment
    29

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionShift-Work Related Sleep Disturbance
    InterventionLemborexant; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Lemborexant in Delayed Sleep Phase Syndrome

    NCT05463861 · start 2022-02-01

    Registered record
    Registry ID
    NCT05463861
    Conditions
    Delayed Sleep Phase Syndrome
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2022-02-01
    Completion
    2026-01-21
    Enrolment
    71

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionDelayed Sleep Phase Syndrome
    InterventionLemborexant; Placebo
    PhasePhase 4
    Registry statusCompleted
  • A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

    NCT04890561 · start 2021-05-17

    Registered record
    Registry ID
    NCT04890561
    Conditions
    Healthy Volunteers
    Interventions
    Lemborexant
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-05-17
    Completion
    2021-08-12
    Enrolment
    8

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteers
    InterventionLemborexant
    PhasePhase 1
    Registry statusCompleted