Drugs / Lemborexant
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed insomnia 5 milestones | |||||
| Filed | EU (EMA) | — | insomnia | 2026-07-16 | “the European Medicines Agency (EMA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist...” eisai.com ↗ |
| Filed | UK (MHRA) | — | insomnia | 2026-07-02 | “MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant” eisai.com ↗ |
| Filed | Other | DAYVIGO | insomnia | 2020-07-08 | “the new drug application for approval of its in-house-discovered and developed orexin receptor antagonist DAYVIGO ® (generic name: lemborexant) for the treatment of adults with...” eisai.com ↗ |
| Filed | Japan (PMDA) | — | insomnia | 2019-03-07 | “application has been submitted in Japan for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for use in the treatment of insomnia disorder.” eisai.com ↗ “submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the United States (December 2018), Japan (March 2019)” eisai.com ↗ “Applications seeking approval of lemborexant for use in the treatment of insomnia disorder were submitted in the United States and Japan, respectively.” eisai.com ↗ “For Japan, a marketing authorization application for lemborexant for use in the treatment of insomnia disorder has been submitted” eisai.com ↗ |
| Filed | US (FDA) | — | insomnia | 2018-12-27 | “submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the United States (December 2018), Japan (March 2019)” eisai.com ↗ “Applications seeking approval of lemborexant for use in the treatment of insomnia disorder were submitted in the United States and Japan, respectively.” eisai.com ↗ “New Drug Application for lemborexant for the treatment of insomnia, filed with the U.S. Food and Drug Administration, on December 27, 2018.” eisai.com ↗ “new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder were submitted in the United States” eisai.com ↗ “today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant” eisai.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | DAYVIGO | — | 2023-04-20 | fda.gov ↗ |
| Approved | US (FDA) | DAYVIGO | — | 2019-12-20 | fda.gov ↗ |
Trials 46
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT04890561 | May → Aug 2021 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04647383 | Jan 2021 → Feb 2022 | chronic obstructive pulmonary disease, obstructive sleep apnea syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04555733 | Oct 2020 → Jan 2021 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03483636 | Mar → Sep 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03471871 | Feb → Aug 2018 | obstructive sleep apnea syndrome | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03443063 | Feb → Aug 2018 | impaired renal function disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03451110 | Feb → Mar 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03440424 | Jan → Apr 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03158025 | Apr 2017 → Jul 2018 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03008447 | Nov 2016 → Jan 2018 | — | Eisai Inc. | Completed | Met primary |
| Phase 1 | NCT02583451 | Nov 2015 → Jan 2017 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02350309 | Dec 2014 → Apr 2015 | insomnia | Eisai Inc. | Completed | Missed primary |
| Phase 1 | NCT02089412 | Feb → May 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02085967 | Feb → Apr 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02046213 | Feb → Apr 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02039089 | Jan → May 2014 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01673880 | Aug → Oct 2012 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01673451 | Aug 2012 → May 2013 | central nervous system disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01463098 | Oct 2011 → Aug 2012 | insomnia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07802990 | Nov 2026 → Nov 2028 expected | cannabis dependence | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07683442 | Sep 2026 → Jun 2028 expected | obstructive sleep apnea syndrome | Chulalongkorn University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05763329 | Feb 2023 → Feb 2025 | obstructive sleep apnea syndrome | Chulalongkorn University | Completed | No outcome recorded |
| Phase 213 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07811401 | Oct 2026 → Dec 2027 expected | sleep disorder | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07695285 | Sep 2026 → Sep 2029 expected | delirium | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06928766 | Oct 2025 → May 2027 expected | obstructive sleep apnea syndrome | Flinders University | Recruiting | No outcome recorded |
| Phase 2 | NCT06981195 | May 2025 → Jul 2029 expected | insomnia, substance-related disorder | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 2 | NCT06823752 | May 2025 → Dec 2027 expected | insomnia | Woolcock Institute of Medical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06648681 | May 2025 → Apr 2027 expected | delirium | University of British Columbia | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07480096 | Oct 2024 → Oct 2025 | cirrhosis of liver, hepatic encephalopathy, insomnia | Indonesia University | Completed | No outcome recorded |
| Phase 2 | NCT06843187 | Sep 2024 → Dec 2027 expected | insomnia, major depressive disorder | Unity Health Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06274528 | Mar 2024 → Mar 2030 expected | Alzheimer disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT05728736 | Mar → Sep 2023 | Alzheimer disease | Brendan Lucey | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05594589 | Nov 2022 → Apr 2024 | sleep disorder, initiating and maintaining sleep | Eisai Inc. | Completed | Met primary |
| Phase 2 | NCT03001557 | Dec 2016 → Jul 2018 | circadian rhythm sleep disorder, irregular sleep wake type | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01995838 | Nov 2013 → Apr 2014 | insomnia | Eisai Inc. | Completed | Missed primary |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT06496282 | Aug 2024 → May 2026 overdue | — | Phramongkutklao College of Medicine and Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04549168 | Nov 2020 → Mar 2023 | sleep disorder, initiating and maintaining sleep | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02952820 | Nov 2016 → Jan 2019 | insomnia | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT02783729 | May 2016 → Jan 2018 | insomnia | Eisai Inc. | Completed | Met primary |
| Phase 46 trials · 1 missed | ||||||
| Phase 4 | NCT07840638 | Oct 2026 → Nov 2029 expected | nocturnal enuresis | University of Alberta | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07407400 | Sep 2026 → Dec 2027 expected | delirium, sleep disorder | Mahidol University | Recruiting | No outcome recorded |
| Phase 4 | NCT07384429 | Aug → Dec 2026 expected | Parkinson disease, insomnia, movement disorder | YangPan | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06093126 | Dec 2023 → Dec 2028 expected | frontotemporal dementia, insomnia | Nova Scotia Health Authority | Recruiting | No outcome recorded |
| Phase 4 | NCT05344443 | Mar 2022 → Nov 2024 | circadian rhythm sleep disorder, shift work type | University of California, San Francisco | Completed | Missed primary |
| Phase 4 | NCT04742699 | Mar 2021 → Jun 2022 | insomnia | Kurume University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06779149 | Apr 2025 → Feb 2027 expected | insomnia | Laval University | Recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1/2 | NCT04818086 Comparator | May 2021 → Apr 2023 | substance-related disorder | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT06231641 Comparator | Jan 2024 → Mar 2026 | circadian rhythm sleep disorder, shift work type | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06262594 Comparator | Oct 2024 → Apr 2026 overdue | epilepsy | University of Manitoba | Recruiting | No outcome recorded |
| Phase 3 | NCT05458609 Comparator | Feb 2023 → Jan 2024 | alcohol-related disorders | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT06874855 Comparator | Mar 2023 → May 2027 expected | circadian rhythm sleep disorder, delayed sleep phase type | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05463861 Comparator | Feb 2022 → Jan 2026 | circadian rhythm sleep disorder, delayed sleep phase type | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-07-16 | Eisai Inc. | Regulatory Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by European Medicines Agency (EMA) eisai.com ↗
Eisai Co., Ltd. announced today that the European Medicines Agency (EMA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant (generic name) for the treatment of adult patients with chronic insomnia. |
| 2026-07-02 | Eisai Inc. | Regulatory Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant for the treatment of adult patients with insomnia, characterised by symptoms present for at least 3 months with considerable impact on daytime functioning. |
| 2025-05-27 | Eisai Inc. | Regulatory New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO® (Lemborexant) in China eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the in-house-discovered and developed orexin receptor antagonist DAYVIGO ® (brand name in China: “达卫可 ® “ generic name: lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. |
| 2021-03-02 | Eisai Inc. | Regulatory NEW DRUG APPROVAL FOR IN-HOUSE DEVELOPED ANTI-INSOMNIA DRUG DAYVIGO® (LEMBOREXANT) IN HONG KONG FIRST DRUG APPROVAL FOR DAYVIGO IN ASIA OUTSIDE OF JAPAN eisai.com ↗
This approval is the first approval for DAYVIGO in Asia outside of Japan. |
| 2020-07-08 | Eisai Inc. | Regulatory NEW DRUG APPLICATION FOR IN-HOUSE DEVELOPED NEW ANTI-INSOMNIA DRUG DAYVIGO® ACCEPTED IN HONG KONG FIRST NEW DRUG APPLICATION FOR DAYVIGO IN ASIA OUTSIDE JAPAN eisai.com ↗
DAYVIGO ® (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, has been accepted by the Hong Kong Department of Health. |
| 2020-01-23 | Eisai Inc. | Regulatory DAYVIGO™ (LEMBOREXANT) APPROVED FOR TREATMENT OF INSOMNIA IN JAPAN NON-SEDATIVE OREXIN RECEPTOR ANTAGONIST DEMONSTRATES EFFECTIVENESS FOR BOTH SLEEP ONSET AND SLEEP MAINTENANCE eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has obtained the manufacturing and marketing approval in Japan for its in-house discovered orexin receptor antagonist DAYVIGO TM (2.5mg, 5mg, and 10mg tablets, lemborexant) for treatment of insomnia. |
| 2019-12-23 | Eisai Inc. | Regulatory U.S. FDA APPROVES EISAI’S DAYVIGO™ (LEMBOREXANT) FOR TREATMENT OF INSOMNIA IN ADULT PATIENTS OREXIN RECEPTOR ANTAGONIST PROVEN EFFECTIVE FOR BOTH SLEEP ONSET AND SLEEP MAINTENANCE IN CLINICAL DEVELOPMENT PROGRAM OF MORE THAN 2,000 PATIENTS eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin receptor antagonist DAYVIGO TM (lemborexant). |
| 2019-03-12 | Eisai Inc. | Regulatory Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia eisai.com ↗ |
| 2019-03-07 | Eisai Inc. | Regulatory MARKETING AUTHORIZATION APPLICATION FOR POTENTIAL INSOMNIA DISORDER TREATMENT LEMBOREXANT SUBMITTED IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a marketing authorization application has been submitted in Japan for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for use in the treatment of insomnia disorder. |
| 2019-02-04 | Eisai Inc. | Results Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society’s Conference: Advances in Sleep and Circadian Science Six-month data show significant improvements in patient-reported measures of sleep onset and sleep maintenance for investigational agent lemborexant eisai.com ↗ |
| 2019-01-15 | Eisai Inc. | Regulatory New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States eisai.com ↗
Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, “Purdue Pharma”) today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder. |
| 2018-10-26 | Eisai Inc. | Results EISAI PRESENTS NEW DATA ON LEMBOREXANT FOR TREATMENT OF IRREGULAR SLEEP-WAKE RHYTHM DISORDER IN PATIENTS WITH ALZHEIMER’S DISEASE AT THE 11TH CLINICAL TRIALS IN ALZHEIMER’S DISEASE CONFERENCE eisai.com ↗
The data were presented at the 11th Clinical Trials in Alzheimer’s Disease (CTAD) Conference in Barcelona, Spain. |
| 2018-10-17 | Eisai Inc. | Results Eisai and Purdue Pharma Announce Positive Topline Results of SUNRISE 2, the Second Phase 3 Pivotal Study of Lemborexant Long-term efficacy and safety evaluation in patients with insomnia, a sleep-wake disorder, met primary and key secondary efficacy objectives eisai.com ↗
Topline results reported today are the primary and key secondary outcomes of the study from the six-month, placebo-controlled treatment period; the study is ongoing to 12 months. |
| 2018-07-02 | Eisai Inc. | Results EISAI TO GIVE ORAL PRESENTATION ON RESULTS OF PHASE III HEAD-TO-HEAD CLINICAL STUDY OF LEMBOREXANT IN INSOMNIA DISORDER AT 43RD ANNUAL MEETING OF THE JAPAN SOCIETY OF SLEEP RESEARCH AT “DRUG DISCOVERY RESEARCH FOR SLEEP MEDICINE” SYMPOSIUM eisai.com ↗
In addition to SUNRISE 1 in which the primary and key secondary objectives were achieved, non-clinical research data from the course of discovery of lemborexant, including medicinal chemistry and pharmacology, will also be highlighted at the symposium. |
| 2018-06-06 | Eisai Inc. | Results Positive New Data on Investigational Lemborexant Presented at 32nd Annual SLEEP Meeting Studies measured postural stability after middle-of-the-night awakening and next morning compared to zolpidem ER, as well as next-morning driving performance eisai.com ↗
Study 108 met its primary endpoint resulting in a statistically significant difference in postural stability with both doses of lemborexant compared to zolpidem ER in the middle of the night. |
| 2018-05-23 | Eisai Inc. | Results EISAI AND PURDUE PHARMA TO PRESENT LATEST PHASE I CLINICAL DATA ON LEMBOREXANT AT 32ND ANNUAL SLEEP MEETING eisai.com ↗
The study demonstrated that postural stability was statistically significantly worse for zolpidem ER 6.25 mg compared with both lemborexant 5 mg and 10 mg in healthy volunteers age 55 and older, and the primary endpoint was achieved. |
| 2018-03-07 | Eisai Inc. | Results EISAI AND PURDUE PHARMA ANNOUNCE POSITIVE TOPLINE RESULTS FROM KEY CLINICAL STUDIES OF LEMBOREXANT INCLUDING FIRST-EVER PHASE 3 HEAD-TO-HEAD SUPERIORITY COMPARISON VERSUS ZOLPIDEM ER IN PATIENTS WITH SLEEP DISORDER eisai.com ↗
The Phase 3 pivotal study, SUNRISE 1, achieved its primary and key secondary objectives versus placebo and versus an active comparator (zolpidem tartrate extended release, “zolpidem ER”) in patients 55 years and older with difficulty staying asleep through the night. |
| 2014-12-10 | Eisai Inc. | Results EISAI DEMONSTRATES EFFICACY OF INVESTIGATIONAL DUAL OREXIN RECEPTOR ANTAGONIST E2006 IN SLEEP INITIATION AND MAINTENANCE DATA FROM PHASE Ⅱ CLINICAL TRIAL FOR INSOMNIA PRESENTED AT 53RD AMERICAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY ANNUAL MEETING eisai.com ↗
In the study, E2006 demonstrated a statistically significant improvement in sleep initiation and sleep maintenance without increasing next-day residual sleepiness when compared with placebo. |
All press releases naming this drug 35 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lemborexant | “the dual orexin-receptor antagonist lemborexant (LEM) in older adults” PMID 39120786 ↗ Aug 2024 |
| Known as | Dayvigo | “Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset...” NCT06779149 ↗4“Lemborexant (trade name Dayvigo), 10mg capsules, administered orally” NCT06981195 ↗ “Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1” NCT05763329 ↗ “Lemborexant 5 MG [Dayvigo] Period 1” NCT07683442 ↗ “Lemborexant 5 MG [Dayvigo]” NCT06231641 ↗ |
| Known as | E2006 | “Lemborexant (E2006)” NCT03440424 ↗ |
| Known as | LEM | “As part of a human abuse potential (HAP) study of lemborexant (LEM), the effects of therapeutic (LEM 10 mg), and supratherapeutic doses of LEM 20 mg and LEM 30 mg on cognition...” PMID 35748777 ↗ Jun 20226“OBJECTIVE: To evaluate effects of lemborexant (LEM), a dual orexin receptor antagonist, on next-morning sleep propensity assessed by a modified Multiple Sleep Latency Test...” PMID 37193566 ↗ Jul 2021 “This study evaluated the efficacy and safety of lemborexant (LEM), a dual orexin-receptor antagonist, in participants with insomnia disorder in China.” PMID 41442783 ↗ Dec 2025 “lemborexant (LEM) 10 mg (LEM10), a competitive dual orexin-receptor antagonist” PMID 40848323 ↗ Aug 2025 “the dual orexin-receptor antagonist lemborexant (LEM) in older adults.” PMID 39120786 ↗ Aug 2024 “lemborexant (LEM), a dual orexin receptor antagonist” PMID 39823487 ↗ Jan 2025 “Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)” NCT04742699 ↗ |
| Action | Inhibit | “a dual orexin receptor antagonist” PMID 37193566 ↗ Jul 2021 |
| Modality | Small molecule | — CHEMBL3545367 ↗ |
| Route | Oral | “single oral doses of E2006” NCT01463098 ↗ |
| Target | HCRTR1 | “Orexin receptor 1 antagonist” CHEMBL3545367 ↗ |
| Target | HCRTR2 | “Orexin receptor 2 antagonist” CHEMBL3545367 ↗ |