Main study objectives To investigate the bioequivalence of the test formulation of Lebrexan tablets (5 mg, produced by Qingyutang Pharmaceutical Co., Ltd., Fu'an Pharmaceutical Group) and the reference formulation (trade name: DAYVIGO®, 5 mg, certified by AEISHI Co., Ltd.) after a single oral administration in healthy subjects under fasting state. Secondary study objectives To observe the safety of the test formulation and the reference formulation of Lebrexan tablets in healthy subjects.

Start Date11 Jul 2025

Sponsor / Collaborator

Chongqing Qingyutang Pharmaceutical Co. Ltd.

NCT06981195

/ RecruitingPhase 2IIT

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

The goal of this clinical trial is to learn about how certain medications used to treat insomnia (e.g., Lemborexant) impact sleep, mood, and behavior in men and women with Opioid Use Disorder who are taking prescribed buprenorphine. The main questions it aims to answer are:
1. What is the effect of the study drug (lemborexant) on sleep outcomes?
2. What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)?
3. What is the effect of the study drug (lemborexant) on mood and other behavior?
Researchers will compare lemborexant to placebo (e.g., sugar pill) to see if participants assigned to 8 weeks of treatment with lemborexant have greater improvements on the measures listed above.
Participants will take the study medication (or placebo) each night for 8 weeks and be asked to come for a total of 23 study visits. Most of these visits will be very short (15-30 minutes). The longer visits will include the screening visit (about 2-3 hrs), baseline visit (about 2.5 hrs), and the post-medication visit (about 2 hrs). Study visits will include things like taking surveys about sleep, drug use, and mood, completing urine drug testing, checking vital signs (e.g., blood pressure), and completing interviews with the study staff. Participants will also be asked to provide two blood samples (one during screening and one after taking the medication). For three two-week periods, participants will be asked to wear a watch to track sleep at home, and to keep a log of sleep and wake times.

Start Date27 May 2025

Sponsor / Collaborator

Virginia Commonwealth University

[+1]

NCT06823752

/ RecruitingPhase 2IIT

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

The goal of this clinical trial is to explore the potential neuroprotective benefits of a dual orexin receptor antagonist (DORA) in adults with insomnia. The main questions it aims to answer are:
* Does the DORA reduce blood-based phosphorylated TAU181, in adults with insomnia, when compared to placebo
* Does the DORA reduce other blood-based biomarkers of neurodegeneration, including phosphorylated TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL) and Glial Fibrillary Acidic Protein (GFAP), when compared to placebo.
Participants will:
* Take 10mg Lemborexant nightly for two weeks
* Take a matching placebo nightly for two weeks
* Visit the research institute for a screening visit and for an overnight visit at the conclusion of each study drug treatment (3 visits in total).

Start Date13 May 2025

Sponsor / Collaborator

Woolcock Institute of Medical Research

100 Clinical Results associated with Lemborexant

100 Translational Medicine associated with Lemborexant

100 Patents (Medical) associated with Lemborexant

289

Literatures (Medical) associated with Lemborexant

01 Dec 2025·SLEEP MEDICINE

Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysis

Review

Author: Alam, Umama ; Hayat, Umair ; Javaid, Hammad ; Rath, Shree ; Khan, Hamza ; Bacha, Zaryab ; Ali, Muhammad Abdullah ; Cheema, Asad Ali Ahmed ; Ahmed, Raheel ; Khan, Allahdad ; Ward, Charles Dominic ; Qadeer, Abdul

BACKGROUND:

Insomnia is a prevalent sleep disorder that significantly impacts quality of life and overall health. Lemborexant, a dual orexin receptor antagonist, has emerged as a promising treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Lemborexant in adults with insomnia.

METHODS:

We systematically searched PubMed, Embase, Cochrane, and clinicaltrials.gov through March 5, 2025, for randomized controlled trials (RCTs) comparing lemborexant with placebo. Primary outcomes included changes in wake after sleep onset (WASO), sleep efficiency, and sleep onset latency. Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-related TEAEs, and headache. Data were synthesized using a random-effects model and assessed for heterogeneity. Meta-analyses used a random-effects model and heterogeneity was assessed using the I² statistic.

RESULTS:

Six RCTs involving 2257 patients were included. Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to -12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced sleep onset latency (MD: 10.85 min; 95 % CI: 18.47 to -3.23). Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference in overall TEAEs or headache compared to placebo.

CONCLUSION:

Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety.

01 Dec 2025·SLEEP MEDICINE

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis

Review

Author: Wang, Ying ; Liu, Hui ; Zhu, Bing ; Wang, Hongfeng ; Liu, Xiaoge ; Li, Mengyuan ; Chen, Xi

BACKGROUND:

Medications, including dual orexin receptor antagonists (DORAs), benzodiazepines (BZDs), Z-drugs and melatonin receptor agonists, are common medications for insomnia disorder, but holistic comparisons of their efficacy and safety are not quite clear.

OBJECTIVE:

To investigate the efficacy and safety profiles of agents for treating insomnia disorder and further establish a clinical algorithm in terms of type of insomnia based on the "time window" generated from adjusting for certain confounding factors.

METHODS:

Relevant randomized controlled trials (RCTs) were retrieved from PubMed, Embase, Scopus, the Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to April 15, 2025. The standard mean difference (SMD) was generated for consecutive variants, including the wake after sleep onset(WASO), latency to persistent sleep(LPS), total sleep time(TST), and sleep efficiency(SE), for pairwise comparisons via Bayesian network meta-regression (NMR) analyses adjusted for the follow-up period and age by RStudio 4.4.2. Pharmacovigilance (PV) was investigated by leveraging the FAERS database, and odds ratios (ORs) were generated for dichotomous and ordinal variants for pairwise comparisons via STATA 18.0 MP.

RESULT:

A total of 15 studies evaluating 10 treatment regimens involving 2408 patients were included in the final analysis. For the WASO, compared with the placebo group, dimdazenil 2.5 mg/d (SMD = -0.388, 95 % CI: -0.608 to -0.166), lemborexant 10 mg/d (SMD = -0.624, 95 % CI: -0.894 to -0.355), lemborexant 5 mg/d (SMD = -0.612, 95 % CI: -0.88 to -0.342), daridorexant 25 mg/d (SMD = -0.957, 95 % CI: -1.436 to -0.479), melatonin 6 mg/d (SMD = -0.741, 95 % CI: -1.423 to -0.044), zolpidem 10 mg/d (SMD = -0.348, 95 % CI: -0.61 to -0.068), doxepin 3 mg/d (SMD = -0.497, 95 % CI: -0.713 to -0.282) were significantly superior. Among the effective regimens, lemborexant 10 mg/d, lemborexant 5 mg/d, daridorexant 25 mg/d, melatonin 6 mg/d, and doxepin 3 mg/d were comparable. However, dimdazenil 2.5 mg/d (SMD = 0.568, 95 % CI: 0.046 to 1.096) and zolpidem 10 mg/d (SMD = 0.608, 95 % CI: 0.074 to 1.171) were significantly inferior to daridorexant 25 mg/d.After adjusting for the follow-up period, the results resembled those of the raw analysis except for the loss of significant superiority of melatonin 6 mg/d (SMD = -0.727, 95 % CI: -1.48 to 0.01) over the placebo. However, melatonin 6 mg/d demonstrated a "time window" of significant superiority over the control group from the 10^th to 40^th weeks. After adjusting for age, dimdazenil 2.5 mg/d (SMD = -0.355, 95 % CI: -0.652 to -0.1), lemborexant 10 mg/d (SMD = -0.508, 95 % CI: -0.9 to -0.114), zolpidem 10 mg/d (SMD = -0.526, 95 % CI: -0.84 to -0.158) demonstrated significant superiority over placebo. In terms of safety, with respect to nervous system disorders, safety signals were detected in suvorexant (IC₀₂₅ = 0.212; 95 % CI: 1.214 to 1.334), lemborexant (IC₀₂₅ = 0.221; 95 % CI: 1.236 to 1.567), daridorexant (IC₀₂₅ = 0.205; 95 % CI: 1.21 to 1.427) and doxepin (IC₀₂₅ = 0.066; 95 % CI: 1.091 to 1.411). In terms of dyspnoea, eszopiclone (OR ranging from 0.556 to 0.669) had significantly lower constituent ratios than daridorexant, melatonin and zolpidem did. Melatonin (OR = 1.568, 95 % CI = 1.192 to 2.061, p = 0.001) and zolpidem (OR = 1.302, 95 % CI = 1.026 to 1.653, p = 0.03) had a significantly higher constituent ratio than suvorexant. The proportion of patients with severe dyspnoea caused by daridorexant (OR = 0.256, 95 % CI = 0.096 to 0.678, p = 0.006) was significantly lower than that caused by suvorexant and lemborexant. For adverse reaction outcomes, zaleplon (OR = 9.888, 95 % CI = 1.124 to 86.944, p = 0.039) had a significantly higher effect than daridorexant on severe dyspnoea.

CONCLUSION:

Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings.

01 Dec 2025·Sleep medicine: X

Self-reported sleep variables, sleep quality, and quality of life assessment in transition to lemborexant in patients with Insomnia: the multicenter, open-label SOMNUS study

Article

Author: Ohshima, Hayato ; Uchimura, Naohisa ; Hirota, Susumu ; Murotani, Kenta ; Hayashida, Kenichi ; Koebis, Michinori ; Habukawa, Mitsunari ; Taninaga, Takehiro ; Ariyoshi, Yu ; Harada, Daisuke ; Ozone, Motohiro ; Ikegami, Azusa ; Hiejima, Hiroshi ; Kotorii, Nozomu ; Nishi, Yurie

Aims:

Lemborexant, a dual orexin receptor antagonist, is approved for treating adults with insomnia. We present diary-based sleep parameters, self-reported sleep quality, insomnia severity, and health-related quality of life following direct transition to lemborexant from previous treatment in Japanese patients with insomnia using data from the SOMNUS Study.

Methods:

The prospective, nonrandomized, open-label, multicenter SOMNUS Study analyzed data from 90 patients across four cohorts of direct switching to lemborexant from Z-drugs (monotherapy cohort: n = 25), suvorexant (monotherapy cohort: n = 25, combination cohort: n = 21), and ramelteon (combination cohort: n = 19) up to 14 weeks.

Results:

Diary-based sleep parameters (subjective sleep onset latency, subjective wake time after sleep onset, subjective total sleep time, and subjective sleep efficiency) significantly improved after transitioning to lemborexant in the 90 patients. At 2, 6, and 14 weeks, significant reductions in Insomnia Severity Index total scores were observed (-2.6 ± 3.81, -4.4 ± 5.13, and -5.3 ± 4.80, respectively; all p < 0.0001). Self-reported sleep quality and morning alertness also showed consistent, significant improvements across all time points. Short Form-8 physical component summary and mental component summary scores demonstrated positive trends, with notable improvements observed in the overall population by the end of the study. Treatment-emergent adverse events (TEAEs) occurred in 47.8 % of patients; most were mild or moderate in severity. No serious TEAEs occurred; somnolence was the most common TEAE.

Conclusions:

These findings indicate that transitioning to lemborexant from previous insomnia treatment is efficacious in improving sleep parameters, insomnia severity, and health-related quality of life, with a favorable safety profile.

Trial registration:

NCT04742699.

News (Medical) associated with Lemborexant

08 Sep 2025

·www.prnewswire.com

Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025

E2086 Showed Potential to Improve Wakefulness in People Living with Narcolepsy Type 1 TOKYO, Sept. 8, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086 have been presented at the World Sleep 2025 congress, held in Singapore from September 5 to 10. These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 (NT1). Continue Reading Clinical Trial Design This randomized, double-blind, single-dose, multiple crossover, Phase Ib clinical trial was conducted in the United States and Canada to evaluate the efficacy, safety, and tolerability of E2086 in people meeting criteria for NT1, compared with placebo and an existing treatment (modafinil). There were a total of 21 patients in the clinical trial (21 patients received the study medication, 19 patients completed the trial). Participants received a single dose of one of five treatments (E2086 5 mg, 10 mg, 25 mg, placebo, or modafinil) shortly after waking, efficacy assessments were conducted for each treatment. Efficacy was assessed using the objective Maintenance of Wakefulness Test (MWT)*1 to evaluate excessive daytime sleepiness (EDS), and subjective sleepiness was measured using the Karolinska Sleepiness Scale (KSS)*2 at the end of each MWT session. Clinical Trial Results As evaluated by MWT, all doses of E2086 demonstrated statistically significant longer sleep latencies*3 – a measure of the ability to stay awake – compared with placebo (P<0.0001 for all doses) and modafinil (E2086 5 mg: P=0.0009; E2086 10 mg and 25 mg: P<0.0001) (See the figure below). For the KSS, all doses of E2086 showed statistically significant higher alertness compared with placebo (P<0.0001), while E2086 10 mg and 25 mg demonstrated statistically significantly higher alertness compared with modafinil (P<0.0001). These outcomes confirmed the Proof of Mechanism for E2086. Treatment-emergent adverse events (TEAEs), based on the 21 patients who received the study medication in the clinical trial, exhibited a dose-dependent trend. The four most frequently observed TEAEs with E2086 included increased urinary frequency (E2086 5 mg: 14.3%, 10 mg: 23.8%, 25 mg: 52.4%), nausea (14.3%, 19.0%, 47.6%), dizziness (4.8%, 23.8%, 38.1%), and urinary urgency (9.5%, 19.0%, 38.1%). No participants discontinued due to TEAEs, and most TEAEs were mild to moderate in severity. No serious TEAEs were reported. Katsutoshi Ido, Ph.D., Chief Scientific Officer at Eisai, commented: "At World Sleep 2025, we presented data supporting the potential of E2086 to improve daytime wakefulness in people diagnosed with narcolepsy type 1. Narcolepsy is a condition with high unmet medical needs, characterized not only by excessive daytime sleepiness but also by symptoms such as cataplexy, hypnagogic/hynopompic hallucinations, and sleep paralysis, all of which significantly impair the quality of life of those affected. The efficacy and safety findings from this trial warrant further investigation in the narcolepsy patient population." Orexin is a neurotransmitter that plays a central role in regulating sleep and wakefulness. Inhibiting orexinergic neurons is believed to promote a natural transition from wakefulness to sleep. Conversely, activating orexinergic neurons is believed to help maintain a more stable state of wakefulness. From the perspective of inhibiting orexinergic neuron activity, Eisai has developed the insomnia treatment DAYVIGO ® (generic name: lemborexant) an orexin receptor antagonist that is available in more than 25 countries worldwide. Furthermore, leveraging the orexin platform established through the development of DAYVIGO, Eisai has created E2086, an orexin receptor agonist that activates orexinergic neurons. In addition to DAYVIGO, Eisai aims to contribute to people living with sleep disorders through the development of E2086. *1 Maintenance of Wakefulness Test (MWT): An objective test that evaluates the ability to stay awake in a sleep-conducive environment. The test is conducted in a quiet examination room with the lights turned off, consisting of four 40-minute sessions carried out at two-hour intervals throughout the day, during which the time taken to fall asleep (sleep latency) is measured using electroencephalography. *2 Karolinska Sleepiness Scale (KSS): A simple subjective scale used to assess the current intensity of sleepiness on a 9-point scale, ranging from "1 - Very clearly awake" to "9 - Very sleepy, struggling against sleepiness". *3 Sleep latency: The amount of time it takes to fall asleep. MEDIA CONTACTS: Eisai Co., Ltd. Public Relations Department, TEL: +81-(0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department + 44 (0) 797 487 9419 Eisai Inc. (U.S.) Libby Holman + 1-201-753-1945 [Notes to editors] 1. About E2086 E2086 is Eisai's in house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels. E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity. 2. About narcolepsy Narcolepsy is a chronic sleep disorder that is characterized by EDS. Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). Due to problems with fatigue, cognition, and persistence of residual symptoms despite treatment, disease burden for narcolepsy is high.1 References 1. Maski. K, et.al. Listening to the Patient Voice in Narcolepsy: Diagnostic Delay, Disease Burden, and Treatment Efficacy. J. Clinical Sleep Medicine. 2017, 13 (3) p419-, SOURCE Eisai Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1

03 Sep 2025

·www.prnewswire.com

Eisai to Present Latest Data on Lemborexant and Novel Orexin Receptor Agonist E2086 at The World Sleep 2025

TOKYO, Sept. 3, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the company will deliver a total of 11 presentations, including clinical data on the selective orexin 2 receptor agonist (OX2R) E2086 and the latest findings on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO®) at the World Sleep Congress (World Sleep 2025) to be held in Singapore from September 5 to 10. Key presentations include results from the Phase Ib clinical study exploring the efficacy (Proof of Mechanism) of E2086 in people diagnosed with narcolepsy type 1 (NT1) and the Phase IV clinical study (SELENADE Study) investigating the effect of lemborexant in people whose insomnia was comorbid with depressive episodes of major depressive disorder and bipolar disorder (Poster 3-133). The company will also host a symposium introducing the latest evidence on lemborexant in Asia. Eisai considers neurology, including sleep disorders such as insomnia and narcolepsy, as a therapeutic area of focus. Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families. Oral Presentations Poster Presentations Eisai-Sponsored Symposium: RISE – Regional Insights in Sleep Excellence Sep.8 (Mon.) 12:45-13:45 PM This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval. [Notes to editors] About lemborexant (product name: DAYVIGO) Lemborexant, an orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of lemborexant to orexin receptors may influence lemborexant's potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects. It has been approved for the treatment of insomnia in more than 25 countries including Japan, the United States, China, Canada, Australia and countries in Asia and the Middle East. About E2086 E2086 is Eisai's in house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels. E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity. About narcolepsy Narcolepsy is a chronic sleep disorder with that is characterized by EDS. Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). Disease burden is high because of problems with fatigue, cognition, and persistence of residual symptoms despite treatment.1 SOURCE Eisai Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Drug Approval

27 May 2025

·www.eisai.com

New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO® (Lemborexant) in China

For Print（312KB） May 27, 2025 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. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm. DAYVIGO binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist with stronger inhibition effect on OX2R, which suppresses both REM and non-REM sleep drive, such that DAYVIGO may provide faster sleep onset and better sleep maintenance to patients. Eisai submitted an application for approval, which was accepted in January 2024, based on the outcome of two pivotal Phase 3 clinical studies (SUNRISE 1: NCT02783729 and SUNRISE 2: NCT02952820) conducted globally in a total of approximately 2,000 adult patients with insomnia, as well as the outcome of a Phase 3 clinical study (Study 311: NCT04549168) conducted in China. Insomnia is characterized by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep, that has occured at least three times a week for at least one month, and which can lead to fatigue, difficulty concentrating and irritability 1,2. The prevalence of insomnia among adults in China is reported to be 15.0% 3, with approximately 172.5 million people thought to suffer from insomnia. 4 DAYVIGO has been approved for the treatment of insomnia in 22 countries and regions, including Japan and the United States, Canada, Australia and countries in Asia. Eisai will continue its efforts to deliver DAYVIGO as a new treatment option to insomnia patients across the world with the hope of contributing to restoration of daytime function and recovery for patients with insomnia by potentially delivering an active daytime life through fast sleep onset and good quality sleep. Media Inquiries: Public Relations Department, Eisai Co., Ltd. +81-(0)3-3817-5120 [Notes to editors] DAYVIGO, an orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). Fast on/off receptor kinetics of lemborexant to orexin receptors may influence lemborexant’s potential to facilitate improvements in sleep onset and maintenance with minimal morning residual effects. It has been approved for the treatment of insomnia in 22 countries including Japan, the United States, Canada, Australia and countries in Asia. References Full text（312KB）

Drug ApprovalPhase 3

100 Deals associated with Lemborexant

External Link

KEGG	Wiki	ATC	Drug Bank
D11022	Lemborexant	N05C	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	Purdue Pharma LP	20 Dec 2016
Alzheimer Disease	Phase 2	United Kingdom	Eisai, Inc.	20 Dec 2016
Sleep Disorders, Circadian Rhythm	Phase 2	United States	Purdue Pharma LP	20 Dec 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06981195 (Pubmed \| BMJ Open)	Phase 2	Sleep Initiation and Maintenance Disorders	100	Lemborexant	zknvnyveia(rwlrhvzahb) = rmhdetxish odxqgfvzdp (ofmgflrmdb ) View more	Positive	01 Oct 2025
NCT05594589 (E2006-J082-204, CTgov)	Phase 2	Sleep Initiation and Maintenance Disorders	65	lemborexant+placebo (Placebo)	ylqlmqhqew(etysjilrdt) = iwcionryao wkrnytcbyf (nmobkoumzx, 59.006) View more	-	03 Jul 2025
				Lemborexant (Lemborexant 5 mg)	ylqlmqhqew(etysjilrdt) = vdzulgexse wkrnytcbyf (nmobkoumzx, 55.263) View more
NCT04549168 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders	194	lemborexant+placebo (Randomization Phase: Placebo)	tjcashgjhq(qtzkdjxriu) = lozmbmnbii osiearzxnf (tayellysun, 42.809) View more	-	20 Dec 2024
				Lemborexant (Randomization Phase: Lemborexant 10 mg)	tjcashgjhq(qtzkdjxriu) = sjurivknlh osiearzxnf (tayellysun, 46.147) View more
NCT04818086 (CTgov)	Phase 1/2	Opioid abuse \| Medication interactions	18	Lemborexant+Buprenorphine-naloxone (Lemborexant Arm)	rdycjcbjmn(xuabmoqvbu) = rjrwkiaydj hdyqijlohb (khiykpdnpt, .94) View more	-	13 Nov 2024
				Placebo+Buprenorphine-naloxone (Placebo Arm)	rdycjcbjmn(xuabmoqvbu) = ujvyrxmbum hdyqijlohb (khiykpdnpt, .82) View more
AAN2024	Not Applicable	Sleep Initiation and Maintenance Disorders \| Sleep Wake Disorders	-	Lemborexant 5 mg	lelgqmywnn(sxeougkuvp) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity lkmbunsnlx (wdvwgtinwa )	-	09 Apr 2024
				Lemborexant 10 mg
NCT04647383 (E2006-A001-113, Pubmed \| J Clin Sleep Med)	Phase 1	Sleep Apnea, Obstructive	33	Lemborexant 10 mg	qqylxyjsfq(tyeriaecys) = ngjkqhqfpo tqqclwokjl (wxmlofehrn )	Positive	01 Jan 2024
				Placebo	qqylxyjsfq(tyeriaecys) = twswueuiom tqqclwokjl (wxmlofehrn )
NCT04890561 (E2006-A001-010, Pubmed \| Br J Clin Pharmacol)	Phase 1	-	8	Lemborexant 10mg	vgcnddnbuw(gvkvdctvrc) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study jluygvwpgs (vkzywwyyzf )	Positive	01 Jan 2024
Somnus Study (WSC2023)	Phase 3	Sleep Initiation and Maintenance Disorders	90	Lemborexant	mwbgyuxwzp(oowhbxqcxj) = improved over time after the transition to treatment with LEM qskfbxsizq (kdidxomdcl ) View more	Positive	24 Oct 2023
NCT04009577 \| NCT04742699 (E2006-A001-312 \| E2006-M081-401, WSC2023)	Not Applicable	-	-	Lemborexant 5mg	ovfvhwdcka(qvgtettnme) = fysbmhydwx wwgfdoodka (uvbwpkduqh ) View more	Positive	24 Oct 2023
				Lemborexant 10mg	ugjvkjcexg(ugltxjdnwm) = piohhxuopx qnsqsqbaqu (plkjgwfxkf )
WSC2023	Not Applicable	Sleep Initiation and Maintenance Disorders	716	Lemborexant	hnosyrlnzv(rwhhejmvia) = szssnkzlfv srupnmaura (xcocbajxcw )	Positive	23 Oct 2023
				Trazodone	hnosyrlnzv(rwhhejmvia) = asffznbntv srupnmaura (xcocbajxcw )

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