Dayvigo

(Lemborexant)

ApprovedSmall molecule

Dayvigo is a small molecule that works as a Orexin Receptor 1 Antagonist; Orexin Receptor 2 Antagonist.[2] It is being used across 18 indications, with its most advanced program in Approved.[1]

Dayvigo is one of 358 small molecule programs targeting Psychiatric Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

357

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Psychiatric DisorderActive, not recruiting

Circadian Rhythm Sleep DisorderApproved

Alzheimer DiseaseRecruiting

Cyclic HematopoiesisApproved

DeliriumActive, not recruiting

Kidney DiseaseApproved

InsomniaCompleted

Chronic PainActive, not recruiting

Sleep DisorderApproved

Post-Operative DeliriumNot yet recruiting

Psychiatric DisorderPreclinical

Active, not recruiting

Circadian Rhythm Sleep DisorderApproved

Approved

Alzheimer DiseaseApproved

Recruiting

Cyclic HematopoiesisApproved

Approved

DeliriumApproved

Active, not recruiting

Kidney DiseaseApproved

Approved

InsomniaApproved

Completed

Chronic PainPreclinical

Active, not recruiting

Sleep DisorderApproved

Approved

Post-Operative DeliriumPhase 2

Not yet recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

105 competitors in Kidney Disease

#DrugCompanyPhaseTrials

Dayvigo

Eisai

Approved

46 2

Rocaltrol

Jazz Pharmaceuticals

Approved

3 3

Tafinlar

Norvir

Neoral

Opzelura

Veozah

Fosrenol

Leqvio

Lorbrena

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Parkinson's Disease

NCT07384429

Recruiting

Psychiatric Disorder

NCT07417813

Q1 2027

N/ARecruiting

Insomnia

NCT06779149

Q2 2027

Phase 3Recruiting

Epilepsy

NCT06262594

Phase 2Not yet recruiting

Post-Operative Delirium

NCT06648681

Post-ApprovalRecruiting

Delayed Sleep Phase Syndrome

NCT06874855

Clinical

Trials by Indication[1]

Insomnia10 trials

A Study of Lemborexant in Chinese Participants With Insomnia Disorder

Completed· Eisai logo

Eisai·Phase 3·NCT04549168·194 enrolled

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

Completed· Eisai logo

Eisai·Phase 3·NCT02783729·1,006 enrolled

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

Recruiting·LLaval University·N/A·NCT06779149·90 enrolled

Show 7 more trials

A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder

Completed· Eisai logo

Eisai·Phase 2·NCT05594589·65 enrolled

Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

Completed· Eisai logo

Eisai·Phase 3·NCT02952820·971 enrolled

A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

Completed· Eisai logo

Eisai··NCT04573556·550 enrolled

Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

Unknown status·GGuangdong Provincial People's Hospital··NCT06225947·200 enrolled

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

Completed·KKurume University·Phase 4·NCT04742699·97 enrolled

Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder

Completed· Eisai logo

Eisai·Phase 1·NCT02350309·69 enrolled

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia Disorder: a Randomised Placebo-controlled Cross-over Study.

Recruiting·WWoolcock Institute of Medical Research·Phase 2·NCT06823752·20 enrolled

Opioid Use Disorder2 trials

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

Completed·VVirginia Commonwealth University·Phase 1/2·NCT04818086·18 enrolled

Neurofunctional Phenotyping to Investigate the Role of the Orexin System at the Intersection of Opioid Use Disorder and Insomnia Among Women and Men Receiving Buprenorphine

Recruiting·VVirginia Commonwealth University·Phase 2·NCT06981195·100 enrolled

Delayed Sleep Phase Syndrome2 trials

Lemborexant in Delayed Sleep Phase Syndrome

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT06874855·15 enrolled

Lemborexant in Delayed Sleep Phase Syndrome

Recruiting·SStanford University·Approved·NCT05463861·86 enrolled

Dementia2 trials

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

Completed· Eisai logo

Eisai·Phase 2·NCT03001557·63 enrolled

Lemborexant for Insomnia in a Patient With Dementia: An N-of-1 Trial

Recruiting·NNova Scotia Health Authority·Phase 4·NCT06093126·1 enrolled

Alcohol1 trial

Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

Completed·—·Phase 3·NCT05458609·8 enrolled

29 more indications

Chronic Obstructive Pulmonary Disease1 trial

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

Completed· Eisai logo

Eisai·Phase 1·NCT04647383·63 enrolled

Sleep1 trial

The Effects of Lemborexant on the Ability to Sleep During Daytime

Recruiting·CCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Phase 2·NCT06231641·24 enrolled

Cirrhosis1 trial

Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems

Completed·IIndonesia University·Phase 2·NCT07480096·82 enrolled

Renal Impairment1 trial

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

Completed· Eisai logo

Eisai·Phase 1·NCT03443063·16 enrolled

ART1 trial

A Single and Multiple Dose Study of Lemborexant in Healthy Chinese Participants

Completed· Eisai logo

Eisai·Phase 1·NCT04555733·26 enrolled

Sleep Quality1 trial

Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers

Recruiting·PPhramongkutklao College of Medicine and Hospital·Phase 3·NCT06496282·50 enrolled

Interaction1 trial

Study of Lemborexant-Alcohol Interaction in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03483636·24 enrolled

Parkinson's Disease1 trial

Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease

Recruiting·YYangPan·Phase 4·NCT07384429·44 enrolled

Treatment1 trial

Lemborexant Shift Work Treatment Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT05344443·29 enrolled

Epilepsy1 trial

Lemborexant Treatment of Insomnia Linked to Epilepsy

Recruiting·UUniversity of Manitoba·Phase 3·NCT06262594·26 enrolled

Drug Interactions1 trial

Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03451110·50 enrolled

Women1 trial

A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

Completed· Eisai logo

Eisai·Phase 1·NCT04890561·8 enrolled

Moderate Hepatic Impairment1 trial

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT03440424·24 enrolled

Obstructive Sleep Apnea1 trial

Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea

Completed· Eisai logo

Eisai·Phase 1·NCT03471871·146 enrolled

Amyloid1 trial

Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

Withdrawn·BBrendan Lucey·Phase 2·NCT05728736

Post-Operative Delirium1 trial

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Not yet recruiting·UUniversity of British Columbia·Phase 2·NCT06648681·60 enrolled

Psychiatric Disorder1 trial

A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders

Recruiting·SShanghai Mental Health Center··NCT07417813·121 enrolled

Abuse Potential1 trial

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

Completed· Eisai logo

Eisai·Phase 1·NCT03158025·39 enrolled

Elderly1 trial

Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects

Completed· Eisai logo

Eisai·Phase 1·NCT02583451·48 enrolled

Chronic Insomnia1 trial

Lemborexant vs Clonidine vs Zopiclone vs Other Sedatives for Managing Chronic Insomnia in Chronic Pain Patients

Recruiting·SSalem Anaesthesia Pain Clinic··NCT05618002·250 enrolled

Parkinson Disease (PD)1 trial

Effect of Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: A Randomized, Double-blinded, Placebo-controlled Clinical Trial

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07903038·128 enrolled

Brain Neoplasms1 trial

Effect of Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07903051·112 enrolled

Postoperative Sleep Disturbance1 trial

The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07811401·130 enrolled

Sleep Disturbance1 trial

Lemborexant for Sleep Promotion and Delirium Prevention in Critically Ill Adults: A Combined Feasibility-Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

Recruiting·MMahidol University·Approved·NCT07407400·100 enrolled

Nocturia1 trial

The LENS Study: Efficacy and Safety of Lemborexant for Patients With Nocturia

Not yet recruiting·UUniversity of Alberta·Approved·NCT07840638·35 enrolled

Cannabis Use Disorder1 trial

Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)

Not yet recruiting·UUniversity of Calgary·Preclinical·NCT07802990·28 enrolled

OSA - Obstructive Sleep Apnea1 trial

Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.

Recruiting·FFlinders University·Phase 2·NCT06928766·15 enrolled

Major Depressive Disorder(MDD)1 trial

Lemborexant for the Treatment of Residual Insomnia in Adequately Treated Major Depressive Disorder: A Pilot Randomized Controlled Trial

Terminated·UUnity Health Toronto·Phase 2·NCT06843187·30 enrolled

Alzheimer disease1 trial

Effect of a Dual Orexin Receptor Antagonist on CSF Alzheimer's Disease Biomarkers

Recruiting·WWashington University School of Medicine·Phase 2·NCT06274528·201 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 20, 2019

DAYVIGO

NDA NDA212028

Apr 7, 2020

DAYVIGO

NDA NDA212028

Aug 25, 2020

DAYVIGO

NDA NDA212028

Mar 11, 2022

DAYVIGO

NDA NDA212028

Jan 25, 2023

DAYVIGO

NDA NDA212028

Apr 20, 2023

DAYVIGO

NDA NDA212028

Feb 19, 2025

DAYVIGO

NDA NDA212028

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Lemborexant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lemborexant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lemborexant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212028). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Dayvigo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Orexin Receptor 1 Antagonist; Orexin Receptor 2 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eisai

Patent Landscape[5]

Patent Cliff

Sep 20, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8268848Sep 20, 2031

10188652Oct 21, 2035

11026944Oct 21, 2035

10702529Oct 21, 2035

Dayvigo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Insomnia10 trials

Opioid Use Disorder2 trials

Delayed Sleep Phase Syndrome2 trials

Dementia2 trials

Alcohol1 trial

Chronic Obstructive Pulmonary Disease1 trial

Sleep1 trial

Cirrhosis1 trial

Renal Impairment1 trial

ART1 trial

Sleep Quality1 trial

Interaction1 trial

Parkinson's Disease1 trial

Treatment1 trial

Epilepsy1 trial

Drug Interactions1 trial

Women1 trial

Moderate Hepatic Impairment1 trial

Obstructive Sleep Apnea1 trial

Amyloid1 trial

Post-Operative Delirium1 trial

Psychiatric Disorder1 trial

Abuse Potential1 trial

Elderly1 trial

Chronic Insomnia1 trial

Parkinson Disease (PD)1 trial

Brain Neoplasms1 trial

Postoperative Sleep Disturbance1 trial

Sleep Disturbance1 trial

Nocturia1 trial

Cannabis Use Disorder1 trial

OSA - Obstructive Sleep Apnea1 trial

Major Depressive Disorder(MDD)1 trial

Alzheimer disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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