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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.

  • Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

    NCT04818086 · start 2021-05-03

    Registered record
    Registry ID
    NCT04818086
    Conditions
    Drug Interaction; Analgesics; Opioid Use Disorder
    Interventions
    Lemborexant; Placebo; Buprenorphine-naloxone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2021-05-03
    Completion
    2023-04-20
    Enrolment
    18

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

    ConditionDrug Interaction; Analgesics; Opioid Use Disorder
    InterventionLemborexant; Placebo; Buprenorphine-naloxone
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

    NCT04742699 · start 2021-03-24

    Registered record
    Registry ID
    NCT04742699
    Conditions
    Insomnia
    Interventions
    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)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-03-24
    Completion
    2022-06-20
    Enrolment
    97

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

    ConditionInsomnia
    InterventionLemborexant (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)
    PhasePhase 4
    Registry statusCompleted
  • A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

    NCT04647383 · start 2021-01-06

    Registered record
    Registry ID
    NCT04647383
    Conditions
    Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders
    Interventions
    Placebo; Lemborexant 10 mg; Placebo; Lemborexant 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-01-06
    Completion
    2022-02-10
    Enrolment
    63

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

    ConditionSleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders
    InterventionPlacebo; Lemborexant 10 mg; Placebo; Lemborexant 10 mg
    PhasePhase 1
    Registry statusCompleted
  • A Study of Lemborexant in Chinese Participants With Insomnia Disorder

    NCT04549168 · start 2020-11-06

    Registered record
    Registry ID
    NCT04549168
    Conditions
    Sleep Initiation and Maintenance Disorders
    Interventions
    Lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-11-06
    Completion
    2023-03-17
    Enrolment
    194

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

    ConditionSleep Initiation and Maintenance Disorders
    InterventionLemborexant; Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants

    NCT04555733 · start 2020-10-26

    Registered record
    Registry ID
    NCT04555733
    Conditions
    Healthy Volunteer
    Interventions
    Lemborexant
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-10-26
    Completion
    2021-01-13
    Enrolment
    26

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

    ConditionHealthy Volunteer
    InterventionLemborexant
    PhasePhase 1
    Registry statusCompleted
  • A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

    NCT04573556 · start 2020-10-17

    Registered record
    Registry ID
    NCT04573556
    Conditions
    Sleep Initiation and Maintenance Disorders
    Interventions
    Lemborexant
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2020-10-17
    Completion
    2022-03-17
    Enrolment
    550

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

    ConditionSleep Initiation and Maintenance Disorders
    InterventionLemborexant
    PhaseNot recorded
    Registry statusCompleted
  • A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia

    NCT04009577 · start 2019-07-15

    Registered record
    Registry ID
    NCT04009577
    Conditions
    Insomnia
    Interventions
    LEM 5 mg; LEM 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-07-15
    Completion
    2020-06-26
    Enrolment
    53

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

    ConditionInsomnia
    InterventionLEM 5 mg; LEM 10 mg
    PhasePhase 3
    Registry statusCompleted
  • Study of Lemborexant-Alcohol Interaction in Healthy Subjects

    NCT03483636 · start 2018-03-12

    Registered record
    Registry ID
    NCT03483636
    Conditions
    Healthy Subjects
    Interventions
    Lemborexant; Alcohol; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-03-12
    Completion
    2018-09-12
    Enrolment
    24

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

    ConditionHealthy Subjects
    InterventionLemborexant; Alcohol; Placebo
    PhasePhase 1
    Registry statusCompleted
  • Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

    NCT03471871 · start 2018-02-21

    Registered record
    Registry ID
    NCT03471871
    Conditions
    Obstructive Sleep Apnea; Healthy Subjects
    Interventions
    Placebo; Lemborexant 10 mg; Lemborexant 25 mg; Placebo; Lemborexant 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-02-21
    Completion
    2018-08-03
    Enrolment
    146

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

    ConditionObstructive Sleep Apnea; Healthy Subjects
    InterventionPlacebo; Lemborexant 10 mg; Lemborexant 25 mg; Placebo +1 more
    PhasePhase 1
    Registry statusCompleted
  • Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

    NCT03451110 · start 2018-02-05

    Registered record
    Registry ID
    NCT03451110
    Conditions
    Healthy Subjects
    Interventions
    lemborexant; Loestrin; famotidine; fluconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-02-05
    Completion
    2018-03-23
    Enrolment
    50

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

    ConditionHealthy Subjects
    Interventionlemborexant; Loestrin; famotidine; fluconazole
    PhasePhase 1
    Registry statusCompleted
  • Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

    NCT03440424 · start 2018-01-26

    Registered record
    Registry ID
    NCT03440424
    Conditions
    Hepatic Impairment
    Interventions
    Lemborexant
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-01-26
    Completion
    2018-04-23
    Enrolment
    24

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

    ConditionHepatic Impairment
    InterventionLemborexant
    PhasePhase 1
    Registry statusCompleted
  • A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users

    NCT03158025 · start 2017-04-19

    Registered record
    Registry ID
    NCT03158025
    Conditions
    Insomnia Disorders
    Interventions
    Zolpidem tablets; Suvorexant tablets, over-encapsulated; Lemborexant tablets; Placebo lemborexant; Placebo zolpidem; Placebo suvorexant
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-04-19
    Completion
    2018-07-04
    Enrolment
    39

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

    ConditionInsomnia Disorders
    InterventionZolpidem tablets; Suvorexant tablets, over-encapsulated; Lemborexant tablets; Placebo lemborexant +2 more
    PhasePhase 1
    Registry statusCompleted
  • Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

    NCT03001557 · start 2016-12-20

    Registered record
    Registry ID
    NCT03001557
    Conditions
    Irregular Sleep-Wake Rhythm Disorder
    Interventions
    Lemborexant 2.5 mg; Lemborexant 5 mg; Lemborexant 10 mg; Lemborexant 15 mg; Lemborexant-matched placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2016-12-20
    Completion
    2020-04-17
    Enrolment
    63

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

    ConditionIrregular Sleep-Wake Rhythm Disorder
    InterventionLemborexant 2.5 mg; Lemborexant 5 mg; Lemborexant 10 mg; Lemborexant 15 mg +1 more
    PhasePhase 2
    Registry statusCompleted
  • Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older

    NCT03008447 · start 2016-11-21

    Registered record
    Registry ID
    NCT03008447
    Conditions
    Healthy Subjects
    Interventions
    LEM5; LEM10; ZOL; PBO
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-11-21
    Completion
    2018-01-03
    Enrolment
    60

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

    ConditionHealthy Subjects
    InterventionLEM5; LEM10; ZOL; PBO
    PhasePhase 1
    Registry statusCompleted
  • Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

    NCT02952820 · start 2016-11-15

    Registered record
    Registry ID
    NCT02952820
    Conditions
    Insomnia Disorder
    Interventions
    lemborexant; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-11-15
    Completion
    2019-01-08
    Enrolment
    971

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

    ConditionInsomnia Disorder
    Interventionlemborexant; Placebo
    PhasePhase 3
    Registry statusCompleted