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.

开始日期2025-05-27

申办/合作机构

Virginia Commonwealth University

[+1]

NCT06648681

/ Not yet recruiting临床2期IIT

A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study

Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.

开始日期2025-05-01

申办/合作机构

University of British Columbia

[+1]

NCT06928766

/ Not yet recruiting临床2期IIT

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.

Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches.
People get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold).
Accordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).

开始日期2025-05-01

申办/合作机构

Flinders University

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100 项与莱博雷生相关的专利（医药）

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项与莱博雷生相关的文献（医药）

2025-09-01·PSYCHIATRY RESEARCH

Global burden of insomnia medication-associated suicidality, 1967–2024: A disproportionality analysis of the global pharmacovigilance database

Article

作者: Cho, Hanseul ; Chung, Eun Kyoung ; Hwang, Jiyoung ; Fond, Guillaume ; Yon, Dong Keon ; Kim, Tae Hyeon ; Boyer, Laurent ; Lee, Kyeongmin ; Lee, Suhyun

BACKGROUND:

While insomnia is recognized as a risk factor for suicidality, the potential influence of insomnia medications on this risk requires further investigation.

METHODS:

We utilized the global pharmacovigilance database, to detect pharmacovigilance signal of insomnia medication-related suicidality from 1967 to 2024. The analysis included benzodiazepines, Z-drugs, antidepressants, first-generation H1 antagonists, and dual orexin receptor antagonists for insomnia medications. Multivariable logistic regression models were used to calculate the reporting odds ratio (ROR) and 95 % confidence interval (CI) of suicidality for each medication class, adjusting for age, sex, and reporting region, with melatonin and its receptor agonist as the reference.

RESULTS:

We identified 13,899 reports of suicidality associated with insomnia medications. Benzodiazepines (ROR, 1.78 [95 % CI, 1.62-1.97]), Z-drugs (1.52 [1.40-1.66]), antidepressants (2.08 [1.88-2.31]), and first-generation H1 antagonists (1.59 [1.45-1.73]) showed stronger signal of suicidality compared to melatonin and its receptor agonist. In contrast, dual orexin receptor antagonists (ROR, 0.36 [0.31-0.42]) exhibited a lower signal risk. The melatonin receptor agonist ramelteon (ROR, 0.29 [0.21-0.39]) showed a weaker signal than melatonin. Similarly, dual orexin receptor antagonists suvorexant (ROR, 0.31 [0.26-0.37]), daridorexant (0.20 [0.14-0.29]), and lemborexant (0.24 [0.11-0.51]) significantly lowered the signal risk of suicidality compared to melatonin.

CONCLUSIONS:

Although this disproportionality analysis did not permit causal interpretation, our study highlights significant variations in suicidality signal risk among insomnia medications, with benzodiazepines, Z-drugs, antidepressants, and first-generation H1 antagonists posing stronger signal, and dual orexin receptor antagonists presenting a weaker signal. Given the limitations of pharmacovigilance data, further studies are needed to confirm these findings and guide safer prescribing practices, particularly for individuals at high risk of suicidality.

2025-09-01·SLEEP MEDICINE

The putative effects of orexin receptor antagonists on pain and sleep in humans: A systematic review

Review

作者: Morin, Charles M ; Puertas-Cuesta, F Javier ; Sangalli, Linda ; Lavigne, Gilles J ; Fabbro, Cibele Dal ; Herrero Babiloni, Alberto

OBJECTIVE:

Orexin antagonists are newer medications for management of insomnia, a condition frequently associated to chronic pain. This systematic review evaluates the effects of orexin receptor antagonists on pain perception and pain-related outcomes in humans, considering their role in both sleep regulation and pain modulation.

METHODS:

A search was conducted in PubMed, Web of Science, Scopus, CINAHL, PsycINFO, and ClinicalTrials.gov, following PRISMA guidelines. Eligible studies included human participants with acute or chronic pain who received orexin receptor antagonists (e.g., suvorexant, lemborexant, daridorexant, filorexant) with pain intensity, pain thresholds, sleep disturbances, and functional outcomes as primary measures. Risk of bias was assessed using RoB 2 for randomized controlled trials (RCTs) and ROBINS-E for observational studies, while the GRADE approach was applied to assess the overall certainty of evidence.

RESULTS:

Out of 488 identified records, four studies met the inclusion criteria (three RCTs, one observational study), totaling 331 participants. No significant improvements in pain intensity were found, though one study observed increased pain sensitivity thresholds in fibromyalgia patients. Conversely, orexin receptor antagonists consistently improved sleep parameters, including total sleep time and sleep onset latency. Evidence certainty was moderate for RCTs and low for the observational study, with imprecision and publication bias as key concerns.

CONCLUSION:

Orexin receptor antagonists improve sleep, but due to the very limited number of studies and small sample sizes, evidence regarding analgesic effects in humans remains inconclusive. The lack of receptor-selective interventions, short treatment durations, and pain condition variability may contribute to these findings. Future trials should investigate mechanistic analgesic effects, receptor-specific therapies, and explore orexin's role in pain phenotypes.

2025-06-24·Translational Psychiatry

Comparative efficacy and safety of daridorexant, lemborexant, and suvorexant for insomnia: a systematic review and network meta-analysis.

Review

作者: Sakuma, Kenji ; Nishii, Yasufumi ; Hamanaka, Shun ; Kishi, Taro ; Citrome, Leslie ; Hatano, Masakazu ; Ikuta, Toshikazu ; Iwata, Nakao

BACKGROUND:

In order to appraise the risk-benefit balance of the three available dual orexin receptor antagonists (DORAs; daridorexant, lemborexant, and suvorexant) for the management of adults with insomnia, we conducted a systematic review and random-effects model network meta-analysis.

METHODS:

Included were all published double-blind, randomized, placebo-controlled trials of these agents. Outcomes included subjective time to sleep onset at month 1 (sTSO, primary), subjective total sleep time at month 1 (sTST, co-primary), subjective wake after sleep onset at month 1, Insomnia Severity Index scores at month 1, all-cause discontinuation, discontinuation due to adverse events, and the incidence of individual adverse events such as somnolence, dizziness, falls, headache, nasopharyngitis, and upper respiratory tract infection.

RESULTS:

This meta-analysis included eight trials (5198 adults, average age = 56.33 years, 67.84% female). The treatment arms included daridorexant 25 mg/day (DAR25), daridorexant 50 mg/day (DAR50), lemborexant 5 mg/day (LEM5), lemborexant 10 mg/day (LEM10), suvorexant 20 mg/day (15 mg/day for people ≥65years, SUV20/15), and placebo. All active-treatments outperformed placebo in terms of all efficacy outcomes. The standardized mean difference (95% CI) in primary outcomes ranged from; sTSO: -0.430 (-0.568, -0.292) for LEM10 to -0.164 (-0.296, -0.031) for SUV20/15 and sTST: -0.475 (-0.593, -0.357) for DRA50 to -0.206 ( -0.330, -0.082) for LEM5. An additional sensitivity analysis suggested that DRA25, LEM10, and SUV20/15 were associated with a higher incidence of somnolence compared to a placebo.

CONCLUSIONS:

Considering that there is no evidence that DORAs are associated with physiological tolerance, withdrawal symptoms, or rebound insomnia when abruptly discontinued, and that sleep architecture is not adversely affected, the DORAs appear to be a favorable choice in managing insomnia disorder in adults.

项与莱博雷生相关的新闻（医药）

2025-06-23

·赛柏蓝

又一失眠新药，获批上市

作者 | 陈芋责编 | 遥望一个月内，又一款失眠新药国内获批；中成药占当前失眠改善药物九成以上市场，独家产品月费用多在300元以上。01又一新药获批上市国内失眠治疗或迎变革 6月23日，先声药业官网发布消息，其与瑞士Idorsia公司合作的抗失眠药盐酸达利雷生片（商品名：科唯可）获国家药品监督管理局批准上市，用于治疗以入睡困难和/或睡眠维持困难为特征的成人失眠患者，且未被作为精神药品管制。先声与Idorsia在2022年11月签订了独家授权协议，获授达利雷生在大中华地区的开发及商业化独家权利。这是继卫材莱博雷生（商品名：达卫可）今年5月下旬在国内获批上市后的第二款双食欲素受体拮抗剂。基于达利雷生在中国市场的潜力，先声与Idorsia还达成了补充协议，调整现有合作条款，先声将通过现金形式一次性支付5000万美元（折合人民币约3.59亿元），并降低科唯可销售里程碑付款和特许权使用费率。据中国睡眠研究会发布的《2025年中国睡眠健康调查报告》，中国近半数（48.5%）成年人存在睡眠困扰，且困扰率随年龄增长逐渐攀升，主要症状表现为入睡困难、夜醒、早醒等。庞大的患者人群催生了巨大市场需求。艾媒咨询数据显示，2024年，中国睡眠经济市场规模达到5349.3亿元‌，预计2027年将增长至6586.8亿元。从药物市场来看，开源证券在此前的研报中提到，2025年中国失眠药物市场预计将超过150亿元，到2030年将增长至211.9亿元。然而，安全、有效且适用于长期治疗的抗失眠药物在国内市场一度处于空白状态。苯二氮䓬类、非苯二氮䓬类等传统抗失眠药物虽能缩短入睡时间，但其过度镇静、认知损伤、梦游等风险，以及耐药性、依赖性的问题限制了其进一步扩大市场，也为新一代药物留下了空间。传统失眠药以GABA受体为作用靶点，通过抑制神经兴奋“强制镇静”，大多属于国家管制精神药品；双重食欲素受体拮抗剂靶向下丘脑食欲素通路，掌管大脑觉醒的“开关”，不改变睡眠结构，既能改善夜间睡眠质量，又避免了日间功能下降。一个月内两款新药获批上市，意味着国内失眠治疗市场或迎来变革。需要注意的是，在莱博雷生、达利雷生之前，默沙东的苏沃雷生是最早获FDA批准的食欲素受体拮抗剂，在获批同年，美国禁毒署列入《管制物质法案》附表IV管理，相比于附表I、II、III，附表Ⅳ内的物质滥用可能性低，管制程度低，有较广泛的医疗用途。苏沃雷生未在国内上市，但国家药监局已于2023年将其列入第二类精神药品目录。目前，双食欲素受体拮抗剂并未有成瘾性证据，但长期用药安全性需持续监测。 02改善失眠药物市场中成药销售占比达九成考虑到传统失眠治疗药物不良反应以及精神类药物管制等因素，不少中轻度失眠患者会选择通过安神类中成药改善睡眠状况。据药智数据此前统计，截至2023年1月31日，中国上市药物中可用于改善失眠的药物约746个，其中化药40个，占5.36%；中成药706个，占94.64%。2017年至2021年，中成药在改善失眠的药物市场中销售占比也在90%左右。米内网数据显示，在中国三大终端六大市场，中成药神经系统疾病用药销售额持续正增长，2024年增长了5.22%，达138.6亿元，创出近六年新高，6个亚类也均呈正增长，其中安神补脑药的市场份额占52.52%，销售额增长了2.8%。从具体产品看，失眠症中成药也诞生了年销售额超10亿元的大单品。其中，佐力药业的乌灵胶囊居于公立医疗机构终端中成药神经系统疾病用药榜首，该药是佐力药业独家OTC产品，属中药1类新药，功能主治补肾健脑、养心安神，用于心肾不交所致的失眠、健忘等。米内网数据显示，其销售额在2023年首次突破10亿元，同比增长15.03%；2024年又进一步增长12.64%，是销售额Top20药品中增速第三高的产品。 2024年中国公立医疗机构终端中成药神经系统疾病用药TOP20产品在零售药店终端，中成药神经系统疾病用药Top20中，安神补脑药达到13个，销售额Top4都是安神补脑药，分别是安神补脑液（非独家）、七叶神安滴丸（云南金七独家产品）、脑心舒口服液（非独家）、乌灵胶囊（佐力药业独家产品），相关产品在功能主治中都提到了失眠或多梦等。 2024年中国零售药店终端中成药神经系统疾病用药TOP20产品价格方面，独家失眠治疗药物的定价大多都不低。今年5月获批的莱博雷生得益于“港澳药械通”政策，早在2023年4月就被纳入了急需进口目录，彼时的定价是498元一盒（5mg*28片）；此次新获批的达利雷生暂未有明确定价，但参考其海外定价，单片价格比莱博雷生高50%左右，若其在中国也维持这一价差，预计每月费用将超过700元。中成药方面，乌灵胶囊（0.33g*27粒）的定价在30元左右，按照其说明书每日3次、每次3粒的用量计算，每月费用约300元；七叶神安滴丸（50mg*36丸）每盒定价在108元左右，按照其1盒吃4天的用量计算，每月费用也超过700元。END内容沟通：郑瑶（13810174402）

引进/卖出上市批准医药出海

2025-06-20

·摩熵医药

5000万美元引进！先声药业抗失眠新药获批上市

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。6月20日，国家药监局（NMPA）官网显示，先声药业申报的盐酸达利雷生片（daridorexant）获批上市（受理号：JXHS2400049/50），用于治疗失眠。截图来源：NMPA官网达利雷生是由Idorsia公司开发的一款靶向食欲素1受体（OX1R）和食欲素2受体（OX2R）的潜在Best-in-Class创新药，属于双食欲素受体拮抗剂（DORA），也是第一个改善患者白天功能的失眠药物。截图来源：摩熵医药药品研发数据库食欲素受体拮抗剂是一类经过临床检验的、安全有效的新型抗失眠药。摩熵医药数据库显示，在全国医院全终端市场中，食欲素受体拮抗剂类药物销售额达5.16亿元，市场份额由卫材的莱博雷生片占据。截图来源：摩熵医药全国医院销售（全终端）数据库与传统镇静催眠药物通过镇静大脑来促进睡眠的疗法不同，达利雷生通过阻断食欲素神经肽（食欲素1和食欲素2）与其受体的结合，帮助失眠患者入睡和保持睡眠，且次日无宿醉感、昏睡感。达利雷生的作用机制2024年5月，先声药业宣布达利雷生针对中国失眠患者开展的 III 期临床试验已达到主要研究终点。这也是此次盐酸达利雷生片获批上市的依据。分析结果显示，与安慰剂相比，每晚睡前服用一片盐酸达利雷生片，可以显著改善失眠患者夜间觉醒等多项睡眠指标，同时安全耐受性良好。截图来源：摩熵医药中国临床试验数据库2022年1月，盐酸达利雷生片在美国获批上市，商品名Quviviq，用于治疗特征为入睡和/或睡眠维持困难的成人失眠症患者。同年11月，先声药业与Idorsia达成协议，以5000万美元的总交易额获得达利雷生在大中华地区的开发和商业化权益。截图来源：摩熵医药全球药物交易数据库当前，盐酸达利雷生片已在美国、英国、欧盟、瑞士、加拿大等地获批上市。《2024中国居民睡眠健康白皮书》显示：59%的中国被调查居民存在失眠症状，仅有不到1/5的人拥有完全正常的无障碍睡眠。临床对高效、安全的失眠治疗药物需求极为迫切。目前，全球共3款OX1R/OX2R拮抗剂上市，除达利雷生外，还有默沙东的苏沃雷生（商品名：Belsomra）和卫材的莱博雷生（商品名：Dayvigo）。截图来源：摩熵医药靶点格局数据库失眠领域的广阔前景也吸引着国内药企加速同类药物研发。扬子江药业的法赞雷生在今年1月提交了上市申请。东阳光药的HEC83518也已进入临床阶段。截图来源：摩熵医药中国药品审评数据库小结盐酸达利雷生片获批上市，为中国失眠患者提供了多样化的治疗选择。随着时间推移，达利雷生有望快速渗透至各级医院，与现有失眠治疗药物（如苯二氮䓬类、非苯二氮䓬类）形成差异化竞争。未来，期待看到更多药企加大研发投入，催生更多优质药物，让每一位被失眠困扰的患者都能重获一夜好眠。END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准临床研究

2025-06-20

·凯莱英药闻

失眠新药！先声药业「盐酸达利雷生片」获批上市

欢迎关注凯莱英要闻6月20日，先声药业与瑞士 Idorsia 公司合作开发的新药盐酸达利雷生片（daridorexant）获NMPA批准上市，用于治疗失眠，此前已在美国、欧洲、日本等地区获批上市。达利雷生本次获批可能是基于一项III期关键性临床研究，其发表于《柳叶刀神经病学》的海外III期临床数据显示，在接受1个月、3个月治疗后，达利雷生较安慰剂显著改善了患者入睡、睡眠维持及自我报告的总睡眠时间，不改变睡眠结构，且未发现依赖性、反跳性失眠、戒断症状和药物滥用证据，显著区分于传统镇静催眠药苯二氮䓬类药物报告的结果。同时安全耐受性良好。关于达利雷生达利雷生最早由瑞士创新药公司Idorsia开发，2022年1月，盐酸达利雷生片在美国获批上市，商品名为Quviviq，用于治疗特征为入睡和/或睡眠维持困难的成人失眠症患者。11月，先声药业与Idorsia达成协议，以超5000万美元的总交易额获得达利雷生在大中华地区的开发和商业化权益。达利雷生（Daridorexant）是新一代抗失眠药物，是一种双食欲素受体拮抗剂，同时作用于食欲素1 型受体（OX1R）和食欲素2 型受体（OX2R）且作用效能相当。与传统镇静催眠药物（如苯二氮䓬类药物）通过镇静大脑来促进睡眠的疗法完全不同，达利雷生通过阻断食欲素神经肽（食欲素A 和食欲素B）与其受体的结合，从而降低觉醒驱动，促使睡眠发生，并且不改变患者的睡眠结构。关于食欲素及OX1R/OX2R食欲素(orexin)是一种多肽，通过受体OX1R和OX2R促进清醒。这些神经肽和受体共同构成食欲素系统。食欲素系统刺激唤醒系统中的目标神经元，导致释放几种促进清醒的化学物质（多巴胺、血清素、组胺、乙酰胆碱、去甲肾上腺素）。在正常情况下，食欲素水平在白天随着清醒度的提高而升高，然后在夜间下降。过度活跃的唤醒系统是失眠的一个重要驱动力。目前，全球共3款OX1R/OX2R拮抗剂上市，其他两款分别为：默沙东的苏沃雷生（Belsomra）和卫材的莱博雷生（Dayvigo）。来源：Insight数据库关于失眠失眠是指尽管有合适的睡眠机会和睡眠环境依然对睡眠时间和(或)质量感到不满足，并且影响日间社会功能的一种主观体验。主要症状表现为入睡困难(入睡潜伏期超过30min)、睡眠维持障碍(整夜觉醒次数≥2 次)早睡、睡眠质量下降和总睡眠时间减少(通常少于6.5 h)，同时伴有日间功能障碍。据中国失眠症诊断和治疗指南，在1～10年的随访研究中，成人失眠持续率为30%～60%，提示失眠的病程具有持续性特征。另一方面，失眠具有一定(自然)缓解性，病程呈现波动性。失眠的持续率具有年龄差异，儿童和青少年期失眠持续率约为15.0%，而中年女性和男性则分别高达42.7%和28.2%。失眠的干预方式主要包括心理治疗、药物治疗、物理治疗和中医治疗。在药物治疗策略的选择上：（1）首选非苯二氮卓类药物，如唑吡坦、右佐匹克隆；（2）首选药物无效或无法依从，更换为另一种短-中效的苯二氮受体激动剂、褪黑素受体激动剂、食欲素受体拮抗剂；（3）添加具有镇静催眠作用的抗抑郁药物（如多塞平、曲唑酮等），尤其适用于伴随焦虑和抑郁症状的失眠患者。（4）长期应用苯二氮受体激动剂慢性失眠患者至少每4周进行1次临床评估。据统计，2022年我国失眠化药市场规模42亿元，同比增长18.9%，其中苯二氮卓类药物销售额占比最高，销售额为14.8亿元，此外失眠新药种阿戈美拉汀（施维雅和豪森制药）增速最快，2022年销售额达到6.4亿元，同比增长29.6%。然而，部分中药和保健品单品已经突破5亿，整体来看失眠化药仍然具备较强增长空间。参考资料：1.德邦证券《失眠化药成长空间巨大，新品放量可期》感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。“在看”点一下

上市批准临床3期临床结果

100 项与莱博雷生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11022	莱博雷生	N05C	DB11951

研发状态

批准上市

10 条最早获批的记录,

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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	Eisai Co., Ltd.	2019-09-03

未上市

10 条进展最快的记录,

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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	Eisai, Inc.	2025-05-01
睡眠	临床2期	加拿大	Eisai, Inc.	2025-05-01
阻塞性睡眠呼吸暂停综合征	临床2期	泰国	University of Chulalongkorn	2023-02-01
阿尔茨海默症	临床2期	美国	Eisai, Inc.	2016-12-20
阿尔茨海默症	临床2期	美国	Purdue Pharma LP	2016-12-20
阿尔茨海默症	临床2期	日本	Eisai, Inc.	2016-12-20
阿尔茨海默症	临床2期	日本	Purdue Pharma LP	2016-12-20
阿尔茨海默症	临床2期	英国	Purdue Pharma LP	2016-12-20
阿尔茨海默症	临床2期	英国	Eisai, Inc.	2016-12-20
日夜节律睡眠障碍	临床2期	美国	Purdue Pharma LP	2016-12-20

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05594589 (CTgov)	临床2期	入睡和睡眠障碍	65	lemborexant+placebo (Placebo)	鑰選築範齋夢簾齋鬱繭(艱膚鑰糧窪獵蓋窪衊餘) = 蓋選齋廠淵窪繭範衊膚廠齋獵製夢齋觸糧築壓 (廠糧鬱積壓壓積鬱餘鏇, 59.006) 更多	-	2025-07-03
				Lemborexant (Lemborexant 5 mg)	鑰選築範齋夢簾齋鬱繭(艱膚鑰糧窪獵蓋窪衊餘) = 觸糧積艱襯鏇憲築廠鬱廠齋獵製夢齋觸糧築壓 (廠糧鬱積壓壓積鬱餘鏇, 55.263) 更多
NCT04549168 (CTgov)	临床3期	入睡和睡眠障碍	194	lemborexant+placebo (Randomization Phase: Placebo)	艱廠繭鏇獵構膚廠製窪(鏇鹹醖艱網築襯鏇夢範) = 遞網鬱製顧選壓鬱鬱餘壓網鏇鏇衊壓製願遞鹹 (夢憲衊蓋鹽鑰鹹選壓鹽, 42.809) 更多	-	2024-12-20
				Lemborexant (Randomization Phase: Lemborexant 10 mg)	艱廠繭鏇獵構膚廠製窪(鏇鹹醖艱網築襯鏇夢範) = 鹽窪憲鑰簾憲鹽構積壓壓網鏇鏇衊壓製願遞鹹 (夢憲衊蓋鹽鑰鹹選壓鹽, 46.147) 更多
NCT04818086 (CTgov)	临床1/2期	阿片滥用 \| 药物相互作用	18	Lemborexant+Buprenorphine-naloxone (Lemborexant Arm)	積觸簾廠鹹憲壓選簾夢(願願淵壓廠齋構鬱鑰鬱) = 夢憲構鑰觸選壓廠築淵窪積鏇餘餘餘網簾觸鏇 (憲窪廠淵夢選壓餘鹽製, .94) 更多	-	2024-11-13
				Placebo+Buprenorphine-naloxone (Placebo Arm)	積觸簾廠鹹憲壓選簾夢(願願淵壓廠齋構鬱鑰鬱) = 廠鹽鏇網淵鹽願鹹觸製窪積鏇餘餘餘網簾觸鏇 (憲窪廠淵夢選壓餘鹽製, .82) 更多
AAN2024	N/A	入睡和睡眠障碍 \| 睡眠-觉醒节律障碍	-	Lemborexant 5 mg	遞範鏇顧鏇顧齋鹹餘製(獵獵衊艱壓齋鹹鑰遞齋) = LEM was well tolerated with most treatment-emergent adverse events mild/moderate in severity 築顧網顧範積鹽獵窪醖 (艱鏇夢鹹艱願鑰範膚鹽 )	-	2024-04-09
				Lemborexant 10 mg
NCT04647383 (E2006-A001-113, Pubmed \| J Clin Sleep Med)	临床1期	阻塞性睡眠呼吸暂停综合征	33	Lemborexant 10 mg	壓構鑰餘艱選艱鑰範鏇(築艱壓齋蓋糧築艱鬱觸) = 製窪鬱憲醖製膚鏇顧衊範鏇構醖觸範衊鬱願淵 (選糧壓膚憲築窪憲醖衊 )	积极	2024-01-01
				Placebo	壓構鑰餘艱選艱鑰範鏇(築艱壓齋蓋糧築艱鬱觸) = 觸窪顧淵積窪繭蓋構繭範鏇構醖觸範衊鬱願淵 (選糧壓膚憲築窪憲醖衊 )
NCT04890561 (E2006-A001-010, Pubmed \| Br J Clin Pharmacol)	临床1期	-	8	Lemborexant 10mg	製醖繭醖膚夢顧鹽窪鹹(壓築鑰醖築願繭襯窪鬱) = Mild treatment‐emergent adverse events were reported in 4 subjects; these all resolved by end of study 築夢膚餘積觸獵齋構餘 (製獵網襯憲網顧鏇獵膚 )	积极	2024-01-01
SFN2023	N/A	入睡和睡眠障碍 \| REM睡眠行为障碍	-	Lemborexant 0 mg/kg	選遞廠淵鹹艱壓淵餘餘(衊築鬱糧築蓋糧構蓋積) = 築鬱壓醖構鏇窪選艱觸蓋顧淵製遞膚積選獵鏇 (繭鏇艱壓構製艱襯壓憲 ) 更多	-	2023-11-12
				Lemborexant 30 mg/kg	選遞廠淵鹹艱壓淵餘餘(衊築鬱糧築蓋糧構蓋積) = 壓獵鹽淵築鹽醖網艱網蓋顧淵製遞膚積選獵鏇 (繭鏇艱壓構製艱襯壓憲 ) 更多
Somnus Study (WSC2023)	临床3期	入睡和睡眠障碍	90	Lemborexant	簾夢構鏇網膚艱夢顧艱(顧選衊蓋襯醖窪遞範淵) = improved over time after the transition to treatment with LEM 選簾鏇簾餘糧簾齋蓋衊 (艱鏇觸襯壓蓋鹽襯範窪 ) 更多	积极	2023-10-24
NCT04009577 \| NCT04742699 (E2006-A001-312 \| E2006-M081-401, WSC2023)	N/A	-	-	Lemborexant 5mg	網鑰簾廠膚顧鹹願衊願(獵築鬱繭鹹蓋齋範鑰淵) = 醖憲醖艱艱齋遞顧壓網齋積鑰窪簾顧顧網遞糧 (齋淵鏇憲醖淵願選鹹遞 ) 更多	积极	2023-10-24
				Lemborexant 10mg	艱積鑰觸願鏇醖艱願鹹(憲壓醖壓膚製齋淵壓繭) = 觸醖積築積淵襯夢築築廠艱鑰憲廠窪夢壓獵淵 (範廠觸淵鹹網鹹遞齋鏇 )
WSC2023	N/A	入睡和睡眠障碍	716	Lemborexant	壓構艱願積糧選蓋觸壓(鹽製構糧顧選簾願觸獵) = 廠壓鏇窪蓋範壓艱鹽淵夢願鹽遞衊艱鬱網築鬱 (憲糧網選廠願餘糧築壓 )	积极	2023-10-23
				Trazodone	壓構艱願積糧選蓋觸壓(鹽製構糧顧選簾願觸獵) = 選鑰網築齋艱構構簾淵夢願鹽遞衊艱鬱網築鬱 (憲糧網選廠願餘糧築壓 )