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更新于：2026-07-28
Lemborexant
莱博雷生
更新于：2026-07-28
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 加拿大 (2019-09-03), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C22H20F2N4O2 |
InChIKeyMUGXRYIUWFITCP-PGRDOPGGSA-N |
CAS号1369764-02-2 |
关联
80
项与 莱博雷生 相关的临床试验NCT07683442
One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
NCT07695285
Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial
NCT07384429
Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease
100 项与 莱博雷生 相关的临床结果
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100 项与 莱博雷生 相关的转化医学
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100 项与 莱博雷生 相关的专利（医药）
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319
项与 莱博雷生 相关的文献（医药）2026-12-01Sleep medicine: X
Effect of lemborexant on insomnia severity, morning alertness, and cognition in participants with insomnia disorder and mild obstructive sleep apnea
Article
作者: Lowe, Alan ; Gottschalk, Raymond ; Ramos, Barbara ; Kumar, Dinesh ; Cheng, Jocelyn Y ; Moline, Margaret
Objective:
To examine the effect of lemborexant (LEM) on insomnia severity, morning alertness, and cognition in participants with COMISA (comorbid insomnia and obstructive sleep apnea [OSA]).
Methods:
This post hoc analysis of study E2006-G000-304 (NCT02783729), a phase 3, randomized, double-blind, 1-month, parallel-group study of LEM 5 mg (LEM5), LEM 10 mg (LEM10), zolpidem tartrate extended-release 6.25 mg (ZOL), and placebo (PBO) included participants with insomnia and mild OSA (≥5 to <15 events/h sleep). Disease severity (assessed via Insomnia Severity Index [ISI]), cognition, and morning alertness were examined.
Results:
This analysis included 410 participants (LEM5, n = 114; LEM10, n = 105; ZOL, n = 113; PBO, n = 78) with COMISA. Mean (SD) changes from baseline in ISI total scores were lower (improved) with LEM5 (-7.1 [5.3]), LEM10 (-7.7 [5.6]), and ZOL (-8.7 [6.7]) versus PBO (-5.7 [5.9]) at Day 31, with LEM10 and ZOL reaching statistical significance (LEM5 vs PBO: P = 0.1100; LEM10 vs PBO: P = 0.0278; ZOL vs PBO: P = 0.0011). LEM did not significantly impact next-morning cognitive functioning and alertness. ZOL negatively impacted power of attention and quality of memory cognitive domains at Days 2/3 and speed of memory retrieval at Days 30/31 versus PBO.
Conclusion:
LEM reduced insomnia severity without significantly impacting next-morning cognitive functioning and alertness in patients with mild untreated OSA.
2026-12-01Sleep medicine: X
Effects of lemborexant on sleep quality and its association with morning alertness: Post hoc analysis of two phase 3 trials
Article
作者: Cheng, Jocelyn Y ; Koebis, Michinori ; Khullar, Atul ; Kumar, Dinesh ; Kogo, Yuki ; Moline, Margaret ; Kuriyama, Kenichi ; Inabe, Kanako ; Yoshiike, Takuya ; Pinner, Kate ; Suzuki, Masahiro
Study objectives:
This analysis was conducted to determine whether lemborexant (LEM) treatment affects ratings of patient-reported sleep quality and to identify subjective and objective parameters associated with improved subjective sleep quality.
Methods:
This was a post hoc analysis of two global phase 3 trials (Study 303: 12-month, randomized, double-blind, placebo-controlled trial; Study 304: 1-month, randomized, double-blind, placebo-controlled, active-comparator trial) of LEM for patients with insomnia. A 9-point Likert scale (higher numbers indicating better quality) was used to assess subjective sleep quality (sQual). Subjective and objective sleep parameters were assessed by electronic sleep diaries and polysomnography, respectively. Spearman's rank correlation analysis and stepwise regression analysis were performed to explore the associations between sleep parameters and sQual.
Results:
The analyses included 949 patients from Study 303 and 743 patients from Study 304. LEM showed significantly larger increases from baseline in sQual than placebo in both studies (least square mean change: placebo 0.89, LEM5 1.17 (p < 0.05), LEM10 1.21 (p < 0.05) at Month 6 in Study 303, and placebo 0.93, LEM5 1.46 (p < 0.001), LEM10 1.35 (p < 0.05) at Month 1 in Study 304). Of subjective sleep parameters, changes in morning alertness showed the strongest association with changes in sQual. The changes in subjective total sleep time and wake after sleep onset were moderately correlated with sQual positively and negatively, respectively. These findings were further confirmed using stepwise regression analyses.
Conclusions:
LEM improved ratings of sQual more than placebo. To improve self-reported sleep quality, lemborexant treatment should focus on improving morning alertness.
Clinical trial registration:
Study 303 (ClinicalTrials.gov NCT02952820): Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2). https://clinicaltrials.gov/study/NCT02952820, Study 304 (ClinicalTrials.gov NCT02783729): Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder (SUNRISE 1). https://clinicaltrials.gov/study/NCT02783729.
2026-10-01SLEEP MEDICINE
Efficacy of lemborexant on sleep quality and neurocognitive outcomes among hospital rotating shift workers: A randomized, double-blind, placebo-controlled trial
Article
作者: Taweepunturat, Tipvilai ; Sithinamsuwan, Pasiri ; Suphanklang, Juthathip ; Dechachongjumroen, Abisith
OBJECTIVE/BACKGROUND:
Rotating shift work affects circadian alignment and sleep continuity, resulting in cognitive impairment and low-grade systemic inflammation in healthcare professional. We assessed the effectiveness of lemborexant 5 mg (LEM5) on sleep, neurocognitive function, inflammatory biomarkers, and health-related quality of life in hospital rotating shift workers experiencing sleep disorders.
PATIENTS/METHOD:
Rotating shift workers aged 20 to 60 years, experiencing inadequate sleep opportunity and suboptimal sleep quality, were randomized in a 1:1 ratio to receive LEM5 or a matching placebo for a duration of 3 weeks, with follow-up extending to 6 weeks. Sleep was evaluated by Fitbit Inspire 2 actigraphy and approved Thai versions of questionnaires (ESS, PSQI). Cognitive outcomes included MoCA, DSST, and GP. Plasma BDNF, IL-6, and CRP levels were assessed at baseline and at week 6.
RESULTS:
Forty-seven participants were randomized (LEM5 n = 25, placebo n = 22), and all completed the follow-up. LEM5 yielded significant improvements in MoCA, DSST, and GP completion times for both hands (all p < 0.001). LEM5 significantly decreased IL-6 and CRP levels, whereas variations in BDNF remained comparable between groups. Actigraphy revealed persistent benefit over 42 days in TST, sSOL, WASO, deep NREM sleep, REM sleep, and SE. The PSQI and EQ-5D visual analogue scores shown considerable improvement with LEM5. Somnolence and nightmares were more prevalent with LEM5; nevertheless, no significant adverse events occurred.
CONCLUSIONS:
LEM 5 improved sleep architecture, cognitive function, inflammatory profiles, and health-related quality of life in rotating shift healthcare workers, indicating its promise as a therapeutic intervention for this high-risk demographic.
100 项与 莱博雷生 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 入睡和睡眠障碍 | 加拿大 | 2019-09-03 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 苏醒期谵妄 | 临床2期 | 加拿大 | 2025-05-01 | |
| 睡眠 | 临床2期 | 加拿大 | 2025-05-01 | |
| 阻塞性睡眠呼吸暂停综合征 | 临床2期 | 泰国 | 2023-02-01 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2016-12-20 | |
| 阿尔茨海默症 | 临床2期 | 美国 | 2016-12-20 | |
| 阿尔茨海默症 | 临床2期 | 日本 | 2016-12-20 | |
| 阿尔茨海默症 | 临床2期 | 日本 | 2016-12-20 | |
| 阿尔茨海默症 | 临床2期 | 英国 | 2016-12-20 | |
| 阿尔茨海默症 | 临床2期 | 英国 | 2016-12-20 | |
| 日夜节律睡眠障碍 | 临床2期 | 美国 | 2016-12-20 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 1,763 | 襯範壓觸衊鬱鬱選醖獵(醖餘餘觸廠繭觸襯壓蓋) = 餘艱積積選醖製願遞鏇 衊鹽醖構選製憲製築餘 (鑰簾艱鹹餘積顧鏇蓋簾 ) | 积极 | 2026-04-25 | |||
襯範壓觸衊鬱鬱選醖獵(醖餘餘觸廠繭觸襯壓蓋) = 積鬱網憲鑰醖糧獵鹹衊 衊鹽醖構選製憲製築餘 (鑰簾艱鹹餘積顧鏇蓋簾 ) | |||||||
临床3期 | 8 | (Lemborexant Plus Naltrexone) | 構獵觸鹹範願夢糧顧選(簾艱願蓋觸衊廠糧鹽鹹) = 壓簾構襯窪鬱憲衊醖壓 鹹鏇網襯蓋構選網構壓 (鏇艱蓋鏇憲獵醖獵積選, 16.77) 更多 | - | 2026-03-24 | ||
(Placebo Plus Naltrexone) | 構獵觸鹹範願夢糧顧選(簾艱願蓋觸衊廠糧鹽鹹) = 繭淵憲糧淵齋醖簾繭廠 鹹鏇網襯蓋構選網構壓 (鏇艱蓋鏇憲獵醖獵積選, 21.94) 更多 | ||||||
临床4期 | 29 | (Active Treatment) | 鬱廠淵遞醖選鹹範膚壓(膚顧鏇廠窪網顧窪淵遞) = 顧艱憲鬱遞壓獵構憲構 願網獵襯繭顧積願蓋繭 (襯襯糧觸構糧製憲蓋醖, 22.0) 更多 | - | 2026-02-04 | ||
Placebo (Placebo Treatment) | 鬱廠淵遞醖選鹹範膚壓(膚顧鏇廠窪網顧窪淵遞) = 獵餘鹹積鑰構鏇網餘壓 願網獵襯繭顧積願蓋繭 (襯襯糧觸構糧製憲蓋醖, 22.4) 更多 | ||||||
临床2期 | 100 | 願獵願獵膚鹹網積鬱廠(襯構艱願簾蓋夢壓鏇鬱) = 衊廠願獵壓壓衊網糧獵 壓願選鏇遞顧觸鏇積膚 (顧襯壓顧鑰淵淵願憲選 ) 更多 | 积极 | 2025-10-01 | |||
临床2期 | 65 | lemborexant+placebo (Placebo) | 衊鹹憲製窪淵膚蓋範鏇(膚鑰築簾觸廠觸膚廠憲) = 範選遞範衊範襯積醖夢 願鹹憲壓鏇鑰醖壓顧遞 (壓繭夢選鹽憲願願觸壓, 59.006) 更多 | - | 2025-07-03 | ||
(Lemborexant 5 mg) | 衊鹹憲製窪淵膚蓋範鏇(膚鑰築簾觸廠觸膚廠憲) = 遞襯齋餘願獵築願觸選 願鹹憲壓鏇鑰醖壓顧遞 (壓繭夢選鹽憲願願觸壓, 55.263) 更多 | ||||||
临床3期 | 194 | lemborexant+placebo (Randomization Phase: Placebo) | 願艱衊鹽範淵襯艱艱願(餘願壓窪簾齋鑰蓋蓋餘) = 構鏇範壓鑰繭衊製繭膚 艱廠範簾廠憲遞構製網 (簾遞簾網構遞餘構鹽製, 42.809) 更多 | - | 2024-12-20 | ||
(Randomization Phase: Lemborexant 10 mg) | 願艱衊鹽範淵襯艱艱願(餘願壓窪簾齋鑰蓋蓋餘) = 願遞夢鹹遞窪遞選遞壓 艱廠範簾廠憲遞構製網 (簾遞簾網構遞餘構鹽製, 46.147) 更多 | ||||||
临床1/2期 | 18 | (Lemborexant Arm) | 糧獵顧鹹齋醖鹹網鑰遞(鏇製淵鏇膚鏇醖鏇憲範) = 顧繭窪糧網網餘憲築願 衊觸鏇繭構衊襯艱範願 (鏇網夢觸醖餘淵膚憲積, .94) 更多 | - | 2024-11-13 | ||
Placebo+Buprenorphine-naloxone (Placebo Arm) | 糧獵顧鹹齋醖鹹網鑰遞(鏇製淵鏇膚鏇醖鏇憲範) = 膚膚餘憲膚淵鏇衊齋窪 衊觸鏇繭構衊襯艱範願 (鏇網夢觸醖餘淵膚憲積, .82) 更多 | ||||||
N/A | - | 製遞網積糧構網窪壓鹹(鑰築鹹齋繭鑰願獵遞淵) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity 廠憲鹹襯觸願糧夢餘觸 (鑰製膚範餘選憲構醖獵 ) | - | 2024-04-09 | |||
临床1期 | 33 | 鬱餘餘窪壓鹽鹹積鹽鬱(製獵齋鏇築簾範夢簾範) = 構遞蓋齋窪鬱窪網壓餘 衊鬱窪構襯餘鏇衊願顧 (鑰齋積窪網淵鏇淵網蓋 ) | 积极 | 2024-01-01 | |||
Placebo | 鬱餘餘窪壓鹽鹹積鹽鬱(製獵齋鏇築簾範夢簾範) = 醖範鬱齋網積衊醖製蓋 衊鬱窪構襯餘鏇衊願顧 (鑰齋積窪網淵鏇淵網蓋 ) | ||||||
临床1期 | - | 8 | 範網鬱積窪夢獵網齋衊(鑰鑰獵願網醖壓夢積餘) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study 鹹廠鑰獵醖壓鹽糧艱鏇 (網遞餘蓋築顧齋夢製齋 ) | 积极 | 2024-01-01 |
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