Delving into the Latest Updates on Lemborexant with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DAYVIGOTM, LEM, Lemborexant (JAN/USAN/INN)

+ [7]

Target

Orexin receptor

Action

antagonists

Mechanism

Orexin receptor antagonists

Therapeutic Areas

Nervous System DiseasesOther DiseasesRespiratory Diseases

Active Indication

Sleep Initiation and Maintenance DisordersEmergence DeliriumSleep+ [2]

Inactive Indication

Pulmonary Disease, Chronic ObstructiveSleep Disorders, Circadian Rhythm

Originator Organization

Eisai Co., Ltd.

Active Organization

Washington University School of Medicine

Eisai Co., Ltd.

Eisai, Inc.

+ [6]

Inactive Organization

Purdue Pharma LP

License Organization

Purdue Pharma LP

SK Chemicals Co. Ltd.

Eisai Korea, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

Canada (03 Sep 2019),

Sleep Initiation and Maintenance Disorders

Regulation-

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Structure/Sequence

Molecular FormulaC22H20F2N4O2

InChIKeyMUGXRYIUWFITCP-PGRDOPGGSA-N

CAS Registry1369764-02-2

The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are:
1. Is Lemborexant safe, feasible, and tolerable to use in the CUD population?
2. Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?
Researchers will compare 10mg Lemborexant to placebo.
Participants will:
* Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase).
* Wear an actigraphy watch continuously for the treatment phase.
* Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase.
* Complete a short daily survey for 35 days total.

Start Date01 Nov 2026

Sponsor / Collaborator

University of Calgary

NCT07840638

/ Not yet recruitingPhase 4IIT

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

Nocturia is defined by doctors as getting up one or more times a night to use the bathroom, where you were asleep before going to use the washroom and then going back to sleep afterward. People who experience this condition describe it was one of their biggest problems. This condition is very common as people get older and can seriously affect older peoples quality of life including disruptions to sleep, daily functioning, risk of falls and even early death.

Start Date15 Oct 2026

Sponsor / Collaborator

University of Alberta

[+1]

NCT07811401

/ Not yet recruitingPhase 2IIT

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

Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.

Start Date08 Oct 2026

Sponsor / Collaborator

Beijing Tiantan Hospital

100 Clinical Results associated with Lemborexant

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100 Translational Medicine associated with Lemborexant

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100 Patents (Medical) associated with Lemborexant

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329

Literatures (Medical) associated with Lemborexant

01 Dec 2026·Journal of Clinical Sleep Medicine

Dual orexin receptor antagonist-assisted dose reduction of benzodiazepines and benzodiazepine receptor agonists: a mirror-image analysis of insurance claims data

Article

Author: Matsui, Kentaro ; Kurihara, Kazuhiro ; Inoue, Yuichi ; Takagi, Shunsuke ; Sugiura, Ko ; Takaesu, Yoshikazu ; Shimura, Akiyoshi

PURPOSE:

Discontinuing benzodiazepines and benzodiazepine receptor agonists (BZ/BZRAs) remains challenging for patients with chronic insomnia despite safety concerns. This study evaluated whether continuous treatment with dual orexin receptor antagonists (DORAs) facilitates a reduction in BZ/BZRA doses among long-term users.

METHODS:

This self-controlled (mirror-image) study, in which each patient served as their own control, used Japanese health insurance claims data (Dokenpo database, 2019-2024). Eligible patients had continuous BZ/BZRA use for ≥ 6 months and initiated suvorexant or lemborexant for ≥ 6 months. Changes in bedtime BZ/BZRA dose (diazepam equivalents) were compared between pre- and post-DORA periods. Logistic regression analyses identified factors associated with ≥ 50% dose reduction and BZ/BZRA discontinuation.

RESULTS:

Prior to DORA initiation, 605 patients were taking a mean of 1.9 ± 1.0 types of BZ/BZRAs at a pretreatment total daily dose of 8.2 ± 7.4 mg diazepam equivalent. Of these, 42.1% achieved ≥ 50% bedtime BZ/BZRA dose reduction and 21.3% achieved discontinuation. Mean bedtime doses decreased in both the suvorexant group (7.2 to 5.2 mg) and the lemborexant group (8.3 to 5.2 mg). In adjusted analyses, age ≥ 65 years was independently associated with both ≥ 50% reduction (odds ratio [OR] 2.485; 95% confidence interval [CI] 1.190-5.192; p = 0.015) and discontinuation (OR 2.636; 95% CI 1.158-6.000; p = 0.021). Lower pretreatment BZ/BZRA dose and lemborexant use were also associated with dose reduction and discontinuation.

CONCLUSION:

DORA treatment for at least six months may support BZ/BZRA dose reduction among long-term users, particularly in older patients.

CURRENT KNOWLEDGE/STUDY RATIONALE:

Discontinuing benzodiazepine and benzodiazepine receptor agonists (BZ/BZRAs) in patients with long-term use remains clinically challenging despite well-documented safety concerns. Whether sustained treatment with dual orexin receptor antagonists (DORAs) facilitates BZ/BZRA dose reduction in real-world practice has not been adequately examined in patients already exposed for six months or longer.

STUDY IMPACT:

Sustained DORA treatment for at least six months was associated with substantial bedtime BZ/BZRA dose reduction and discontinuation among long-term users, with older adults (aged 65 years or older) showing the highest odds of success. These findings support DORA co-administration as a practical pharmacological switching strategy to enable safer insomnia management, particularly in populations vulnerable to BZ/BZRA-related adverse events.

01 Dec 2026·SLEEP MEDICINE

Dose-response meta-analysis of dual orexin receptor antagonists on sleep parameters and implications for orexin-mediated arousal

Review

Author: Sampogna, Gaia ; Toni, Claudia ; Caiazza, Claudio ; Palagini, Laura ; Riemann, Dieter ; Fiorillo, Andrea ; Maffucci, Alessia

OBJECTIVE:

The dose-response profiles of dual orexin receptor antagonists (DORAs) remain incompletely characterized, despite their wide usage in insomnia disorder. We aimed to define relationships between dose, sleep parameters and sleep-architecture outcomes for daridorexant, lemborexant, and suvorexant.

METHODS:

We searched PubMed, EMBASE, CENTRAL, and ClinicalTrials.gov until 06/14/2026, for randomized placebo-controlled trials of daridorexant, lemborexant, and suvorexant in adults with insomnia disorder. Placebo-adjusted mean differences at first post-baseline and repeated-use assessments were modelled using one-stage random-effects dose-response meta-analysis with natural splines. E_MAX models were applied when spline models were implausible.

RESULTS:

Twenty-one studies were included in the analyses. All three DORAs showed dose-related improvements in sleep-continuity outcomes, including total sleep time, wake after sleep onset, sleep efficiency, and sleep-onset measures. Curves frequently showed saturating or plateau-like patterns within or near approved dose ranges, suggesting limited incremental benefit at supratherapeutic doses. Some effects were larger at first assessment and modestly attenuated after repeated use, although endpoint effects persisted. Lemborexant showed lower attenuation for selected sleep-continuity outcomes. Sleep-architecture analyses suggested broad preservation of physiological sleep organization, with modest drug-specific changes in N1, N2, slow-wave sleep (SWS), REM sleep, and REM latency.

CONCLUSION:

DORAs produce dose-related improvements in insomnia sleep-related outcomes, with most effects plateauing within therapeutic ranges. This pattern is consistent with a pharmacodynamic ceiling whereby sufficient attenuation of orexin-mediated arousal is achieved within approved dose ranges, limiting the value of further dose escalation. These findings do not support supratherapeutic dosing and suggest that clinical response may be better judged after repeated administration.

01 Dec 2026·Journal of Clinical Sleep Medicine

Effects of lemborexant vs placebo on total daytime sleep in shift workers: a randomized controlled trial

Article

Author: Ovais, Tashia ; Krystal, Andrew D ; Plaut, Traci Coggins ; Prather, Aric A ; Mitgang, Danielle

PURPOSE:

Sleep difficulties are common among shift workers, likely due to a misalignment of one's sleep preference and endogenous circadian rhythm. Treatments to improve daytime sleep in shift workers have been limited; however, the development of dual orexin receptor antagonists (DORAs) that block the hypocretin/orexin receptors that mediate wakefulness promoted by the biological clock holds promise. The present small randomized controlled trial tested the efficacy of the DORA, lemborexant, in improving daytime sleep in night shift workers compared with placebo.

METHODS:

This double-blind, placebo-controlled randomized clinical trial tested the effects of lemborexant on daytime sleep duration in a sample of night shift workers. Participants (n = 29; mean age = 37.2 years; 28 female) underwent a 2-week baseline period followed by randomization and a 1-week titration period where participants received either 5 mg of lemborexant or placebo. This was followed by a 2-week period at either 5 mg (n = 8) or 10 mg (n = 7) lemborexant or placebo. Sleep diaries and wrist actigraphy were collected to quantify daytime sleep duration, sleep efficiency, and subjective sleep quality.

RESULTS:

Linear mixed models failed to reveal any significant differences in daytime sleep duration between the lemborexant group (n = 15) and the placebo group (n = 14) using either diary or wrist actigraphy. Similarly, the lemborexant group did not differentially improve in other sleep outcomes, including sleep efficiency, subjective sleep quality, or insomnia severity. Exploratory analyses revealed a statistically significant benefit to diary-based sleep duration among participants who titrated up to the 10 mg dose compared to 5 mg; however, this was not statistically different than the placebo condition. No serious adverse events were reported in the lemborexant group.

CONCLUSIONS:

This pilot randomized controlled trial of lemborexant, a dual orexin receptor antagonist, failed to demonstrate improvements in daytime sleep duration in shift workers compared to a placebo condition; however, exploratory analyses suggested potential benefits at the 10 mg dose. Future studies with larger samples that ensure participants receive an adequate dose are needed.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT05344443.

CURRENT KNOWLEDGE/STUDY RATIONALE:

Sleep difficulties are common among shift workers, likely due to a misalignment of one's sleep preference and endogenous circadian rhythm. Treatments to improve daytime sleep in shift workers have been limited, though initial evidence suggests that dual orexin receptor antagonists may be efficacious. This study aimed to test the effect of lemborexant on daytime sleep in shift workers.

STUDY IMPACT:

Treatments to improve daytime sleep in shift workers are urgently needed. While this study failed to find an overall effect of lemborexant on daytime sleep compared to placebo, exploratory analyses suggested a larger benefit in daytime sleep duration for participants who received the 10 mg lemborexant dose. This pilot study raises the importance of ensuring shift workers receive an adequate medication dose to improve daytime sleep.

27

News (Medical) associated with Lemborexant

28 Jul 2026

·www.eisai.com

Marketing Authorization Application for In-house Developed Insomnia Drug Lemborexant Accepted for Evaluation by European Medicines Agency (EMA)

Our news releases are intended to disclose corporate information and are not intended for the promotion or advertising of prescription pharmaceuticals or investigational products, nor are they intended to provide medical advice. Please note that the information contained in news releases is current as of the date of publication.

NDA

06 Jul 2026

·www.eisai.com

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)

For Print（311KB） July 2, 2026 Full text（311KB） Our news releases are intended to disclose corporate information and are not intended for the promotion or advertising of prescription pharmaceuticals or investigational products, nor are they intended to provide medical advice. Please note that the information contained in news releases is current as of the date of publication.

Emergency Use Authorization

25 May 2026

·firstwordpharma.com

Biopharma bites: Eisai maps growth path through 2028, plus UN embraces vaccines to defeat superbugs

Eisai lays out growth blueprint anchored by LeqembiUN plan makes vaccines a frontline weapon against superbugsEisai lays out growth blueprint anchored by LeqembiEisai unveiled a new three-year growth strategy that aims to lift annual revenue to JPY 1 trillion ($6.3 billion) and core operating profit to JPY 90 billion by fiscal 2028, driven largely by expansion of its Alzheimer's treatment Leqembi (lecanemab), as well as its insomnia therapy Dayvigo (lemborexant) and cancer drug Lenvima (lenvatinib).Leqembi is projected to generate JPY 300 billion in annual revenue by fiscal 2028, up from JPY 88 billion in fiscal 2025. Eisai recently projected Leqembi sales of JPY 143.5 billion for fiscal 2026, spurred by efforts to improve diagnosis-to-treatment pathways, as well as an anticipated US approval in August for the drug's subcutaneous auto-injector formulation as a starting dose for early Alzheimer's patients. Eisai also anticipates Dayvigo will bring in annual sales of JPY 100 billion by fiscal 2028, versus JPY 64.3 billion in fiscal 2025. Cancer medicine Lenvima is expected to remain a major contributor despite looming generic pressure, with Eisai forecasting JPY 250 billion in sales by fiscal 2028 compared with JPY 342.5 billion in fiscal 2025.Citi analyst Hidemaru Yamaguchi described Eisai's strategy as "a transition from a bullish stance to a conservative one," while also citing concerns about "anticipated deterioration in the product mix, which is somewhat negative."1.00 JPY = 0.00629275 USDUN plan makes vaccines a frontline weapon against superbugsIn the UN's updated Global Action Plan on Antimicrobial Resistance (GAP-AMR) 2026-2036, vaccination – within a broader "prevention-first" approach – has been elevated from a supporting measure to a much more central pillar for fighting drug-resistant superbugs. This second edition of the strategy builds on the first GAP-AMR adopted by the World Health Assembly in 2015.The new plan directs countries to strengthen national immunisation programmes specifically to reduce preventable infections and the need for antibiotics, arguing that prevention is a key strategy for slowing the rise of antimicrobial resistance.Additionally, the plan suggests that the traditional volume-based sales model for antibiotics is unsustainable. "Research and development may be incentivised through a mix of 'push' mechanisms that lower the costs and risks of new antimicrobial or product development, and 'pull' incentives that…delink revenues from sales volumes, thereby encouraging innovation while safeguarding the appropriate use and disposal of antimicrobials."

Drug ApprovalVaccine

100 Deals associated with Lemborexant

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External Link

KEGG	Wiki	ATC	Drug Bank
D11022	Lemborexant	N05C N05CJ02	DB11951

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	Canada	Eisai Co., Ltd.	03 Sep 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Emergence Delirium	Phase 2	Canada	Eisai, Inc.	01 May 2025
Sleep	Phase 2	Canada	Eisai, Inc.	01 May 2025
Sleep Apnea, Obstructive	Phase 2	Thailand	University of Chulalongkorn	01 Feb 2023
Alzheimer Disease	Phase 2	United States	Eisai, Inc.	20 Dec 2016
Alzheimer Disease	Phase 2	United States	Purdue Pharma LP	20 Dec 2016
Alzheimer Disease	Phase 2	Japan	Purdue Pharma LP	20 Dec 2016
Alzheimer Disease	Phase 2	Japan	Eisai, Inc.	20 Dec 2016
Alzheimer Disease	Phase 2	United Kingdom	Eisai, Inc.	20 Dec 2016
Alzheimer Disease	Phase 2	United Kingdom	Purdue Pharma LP	20 Dec 2016
Sleep Disorders, Circadian Rhythm	Phase 2	United States	Eisai, Inc.	20 Dec 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07480096 (RESTORE, Pubmed \| Aliment Pharmacol Ther)	Phase 2	Liver Cirrhosis	82	Placebo	uvpqphchwo(petsklhqba): MD = 16.7, P-Value = 0.048	Positive	01 Aug 2026
				Lemborexant 10 mg
NCT02783729 (E2006-G000-304, AAN2026)	Phase 3	Sleep Initiation and Maintenance Disorders	1,763	Lemborexant 5mg	hhrmddegji(wnnpaqusmk) = mxlbibmxhd vkshpltdci (zfmgjoelae )	Positive	25 Apr 2026
				Lemborexant 10mg	hhrmddegji(wnnpaqusmk) = eemjcrybwp vkshpltdci (zfmgjoelae )
NCT05458609 (CTgov)	Phase 3	Alcohol Use Disorder	8	Lemborexant 10 mg+Naltrexone (Lemborexant Plus Naltrexone)	mvqypkayzo(nnsxovovro) = hklmjipcxi ubhbdlqoay (pomtxxuhoz, 16.77) View more	-	24 Mar 2026
				Naltrexone (Placebo Plus Naltrexone)	mvqypkayzo(nnsxovovro) = ycxydjbpea ubhbdlqoay (pomtxxuhoz, 21.94) View more
NCT05344443 (CTgov)	Phase 4	Sleep Disorders, Circadian Rhythm	29	Lemborexant (Active Treatment)	ctwvknirjk(agrdiotfgw) = flfnhyokgi jalgarxvox (sldwixnnyq, 22.0) View more	-	04 Feb 2026
				Placebo (Placebo Treatment)	ctwvknirjk(agrdiotfgw) = yuirrtajab jalgarxvox (sldwixnnyq, 22.4) View more
NCT06981195 (Pubmed \| BMJ Open)	Phase 2	Sleep Initiation and Maintenance Disorders	100	Lemborexant	utpbkbsgml(oeusoqzgfg) = jmywmsxzpy juvyqrslwn (auctjlkxvi ) View more	Positive	01 Oct 2025
NCT05594589 (E2006-J082-204, CTgov)	Phase 2	Sleep Initiation and Maintenance Disorders	65	lemborexant+placebo (Placebo)	qyhexmtnwf(xttpsxhxlx) = dsdotevrwn upmqviqocm (bwwolyolpb, 59.006) View more	-	03 Jul 2025
				Lemborexant (Lemborexant 5 mg)	qyhexmtnwf(xttpsxhxlx) = iiuynlioxw upmqviqocm (bwwolyolpb, 55.263) View more
NCT04549168 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	194	lemborexant+placebo (Randomization Phase: Placebo)	vpitoxklrw(rfbqfbaktb) = azapkeflxy trvdarzzyr (ajropewpcl, 42.809) View more	-	20 Dec 2024
				Lemborexant (Randomization Phase: Lemborexant 10 mg)	vpitoxklrw(rfbqfbaktb) = fbzkrsrgno trvdarzzyr (ajropewpcl, 46.147) View more
NCT04818086 (CTgov)	Phase 1/2	Opioid abuse \| Medication interactions	18	Lemborexant+Buprenorphine-naloxone (Lemborexant Arm)	opjwpnzexy(eydyhhlrwt) = owicgwcqxm qwxrhuguyk (qzayddfbrp, .94) View more	-	13 Nov 2024
				Placebo+Buprenorphine-naloxone (Placebo Arm)	opjwpnzexy(eydyhhlrwt) = ufmdphkusu qwxrhuguyk (qzayddfbrp, .82) View more
AAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders \| Sleep Wake Disorders	-	Lemborexant 5 mg	pknypujnmt(cpmprpizfv) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity qoytpcmbbk (hcnqnfivku )	-	09 Apr 2024
				Lemborexant 10 mg
NCT04890561 (E2006-A001-010, Pubmed \| Br J Clin Pharmacol)	Phase 1	-	8	Lemborexant 10mg	lkmqjyapwj(tqsheaulrk) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study gsuhspxiax (dozizdmijh )	Positive	01 Jan 2024