Overview
Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits. Whereas historically popular pharmacologic treatments for insomnia (e.g. zopiclone, zolpidem, benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. suvorexant) act to counteract inappropriate wakefulness. This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.
Indication
Lemborexant is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/20 | Phase 2 | Recruiting | |||
2025/04/15 | Phase 2 | Not yet recruiting | |||
2025/03/25 | Phase 2 | Recruiting | |||
2025/03/13 | Phase 4 | Recruiting | |||
2025/02/24 | Phase 2 | Not yet recruiting | |||
2025/01/16 | Not Applicable | Recruiting | |||
2024/10/18 | Phase 2 | Not yet recruiting | |||
2024/07/11 | Phase 3 | Recruiting | Phramongkutklao College of Medicine and Hospital | ||
2024/02/23 | Phase 2 | Recruiting | |||
2024/02/16 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eisai Inc. | 62856-405 | ORAL | 5 mg in 1 1 | 1/24/2024 | |
| Eisai Inc. | 62856-410 | ORAL | 10 mg in 1 1 | 1/24/2024 | |
| Eisai Inc. | 62856-455 | ORAL | 5 mg in 1 1 | 1/24/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DAYVIGO FILM-COATED TABLET 10MG | SIN16321P | TABLET, FILM COATED | 10 mg | 9/15/2021 | |
| DAYVIGO FILM-COATED TABLET 5MG | SIN16320P | TABLET, FILM COATED | 5 mg | 9/15/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DAYVIGO TABLETS 10MG | N/A | N/A | N/A | 2/28/2021 | |
| DAYVIGO TABLETS 5MG | N/A | N/A | N/A | 2/28/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DAYVIGO lemborexant 10 mg film coated tablet blister pack | 338645 | Medicine | A | 7/16/2021 | |
| DAYVIGO lemborexant 5 mg film coated tablet blister pack | 338631 | Medicine | A | 7/16/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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