MedPath

Lemborexant

Generic Name
Lemborexant
Brand Names
Dayvigo
Drug Type
Small Molecule
Chemical Formula
C22H20F2N4O2
CAS Number
1369764-02-2
Unique Ingredient Identifier
0K5743G68X

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DAYVIGO
02507366
Tablet - Oral
5 MG
11/6/2020
DAYVIGO
02507374
Tablet - Oral
10 MG
11/6/2020

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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