The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:
* Is SUV effective for AUD?
* Does SUV dampen stress reactivity?
* Can the researchers develop a biomarker for SUV treatment response?
Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.
Participants will:
* Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks.
* Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG).
* Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.

开始日期2025-12-01

申办/合作机构

The Ohio State University

[+1]

NCT06655883

/ Recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

开始日期2025-10-09

申办/合作机构

Merck Sharp & Dohme LLC

NCT06788522

/ Not yet recruiting临床4期IIT

The Effects of Orexin Antagonism on Fear Extinction in PTSD

PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep. Treatments for PTSD are based on fear extinction principles in which individuals are repeatedly exposed a feared cue in the absence of danger, resulting in diminishing physiological reactions, a process believed to underlie recovery from PTSD. Studies suggest that orexin, a wake-promoting neuropeptide, may enhance fear extinction. This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia. Finding a role for orexins in fear extinction will support the rationale for its further evaluation in the treatment of PTSD. Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing symptoms in Veterans with PTSD.

开始日期2025-10-01

申办/合作机构

VA Office of Research and Development

100 项与舒沃雷生相关的临床结果

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100 项与舒沃雷生相关的转化医学

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100 项与舒沃雷生相关的专利（医药）

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525

项与舒沃雷生相关的文献（医药）

2025-12-01·EXPERIMENTAL NEUROLOGY

Suvorexant attenuates cognitive impairment associated with circadian rhythm sleep-wake disorders by modulating microglia activation via the BMAL1/NLRP3 pathway

Article

作者: Yang, Guoshuai ; Hu, Yujie ; Yun, Tian ; Hou, Dan

BACKGROUND:

Circadian rhythm sleep-wake disorders (CRSD) and cognitive impairment are common features of many neurological disorders. Suvorexant is a novel drug for the treatment of insomnia. The study aimed to investigate the effects and potential mechanisms of suvorexant in alleviating CRSD.

METHODS:

The photothermal displacement-induced CRSD model rats were treated with suvorexant to investigate its impact on cognitive function, the BMAL1/NLRP3 axis-related genes, the microglial marker IBA1, Aβ levels, and the expression of inflammatory factors. Subsequently, hippocampal delivery of sh-BMAL1 was used to investigate the specific mechanism by which suvorexant alleviates the CRSD model.

RESULTS:

Suvorexant treatment significantly decreased sleep latency and escape latency, while increasing sleep time, swimming speed, the number of crossings, and the time spent in each quadrant in the CRSD group. Moreover, Suvorexant was found to upregulate the levels of BMAL1, IL-10, CD206, and TGF-β in CRSD rats, and downregulate the levels of NLRP3, IL-1β, Aβ1-40, Aβ1-42, IL-6, TNF-α, and iNOS. The sh-BMAL1 intervention reversed suvorexant's effects, suggesting that BMAL1 may play a role in how suvorexant influences cognitive impairment in CRSD rats.

CONCLUSION:

Suvorexant may improve CRSD-related cognitive impairment by modulating microglial activation and the BMAL1/NLRP3 pathway, providing potential insights into related conditions.

2025-12-01·SLEEP MEDICINE

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

Review

作者: Wang, Ying ; Liu, Hui ; Zhu, Bing ; Li, Mengyuan ; Wang, Hongfeng ; Liu, Xiaoge ; 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.

2025-12-01·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

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

项与舒沃雷生相关的新闻（医药）

2025-09-24

·药通社

抗失眠药，也卷起来了

睡眠，作为人体不可或缺的生理需求，却成为了我国众多成年人的 “难题”。据中国睡眠研究会《2025 年中国睡眠健康调查报告》显示，我国 18 岁及以上人群中，睡眠困扰率高达 48.5%。这一数据背后，不仅反映出国民睡眠健康问题的严峻性，更揭示出抗失眠药物领域巨大的市场需求。据悉，9月16日，扬子江药业集团表示，公司自主研发的1类抗失眠创新药法赞雷生的新药上市申请已被受理。法赞雷生是一款双重食欲素受体拮抗剂(YZJ-1139片)，它能够同时抑制食欲素受体1型和2型，加快睡眠速度，延长深睡时间。同时扬子江还发布了法赞雷生Ⅲ期关键性临床研究成果：共1034例成人失眠症患者服用试验药物，结果显示，在成人失眠患者中表现出快速起效和良好的安全性。国内抗失眠药，也是卷起来了。 ↓ 扫码加入药通社交流群 ↓ 简单梳理一下国内的主要失眠药物以及发展过程，抗失眠药主要分四代。第一代抗失眠药主要是苯巴比妥类，副作用过大，已不作为抗失眠一线药物使用。第二代抗失眠药主要是苯二氮卓类的镇静催眠药，又叫安定药物，包括艾司唑仑、氟西泮、替马西泮、三唑仑、夸西泮和地西泮等。二代药物的问题在于半衰期较长，发生依赖和成瘾的风险较高，在有其他更安全药物可选的情况下，也几乎已经排除初始使用。第三代抗失眠药主要是非苯二氮卓类的催眠剂，如唑吡坦、扎来普隆、佐匹克隆、右佐匹克隆等。这类药物同样存在生理依赖性问题，长期使用后停用会引发戒断症状，次日晨间残留镇静的风险较高，在我国被归为二类精神药品管理。简单来说，前三代抗失眠药均存在不小弊端，由此产生了第四代抗失眠药——双重食欲素受体拮抗剂。相较于传统失眠药物，食欲素受体拮抗剂可凭借独特机制，减少唤醒驱动、诱导睡眠发生、且不改变睡眠结构，没有次日残留效应和药物依赖性，可以很好弥补前三代药物的不足。第四代抗失眠药的问世迅速革新了失眠治疗领域，也成为行业的热门研究方向。截至目前，全球第四代抗失眠药的代表药物共有3个：苏沃雷生、莱博雷生和达利雷生。默沙东的苏沃雷生是全球首个上市的食欲素受体拮抗剂，于2014年8月13日获FDA批准上市，至今并未在我国上市。值得注意的是，虽未在国内上市，2023年4月，苏沃雷生依旧被列入第二类精神药品目录。目前仅有天津天药药业股份有限公司以3类仿制提交了苏沃雷生的仿制药上市申请。而卫材的莱博雷生和先声＆Idorsia的达利雷生则均已于今年在我国获批上市，前者于5月获批，后者仅落后1个月。同属于第四代抗失眠药，获批时间仅差一个月，自然免不了比较和竞争，而站在消费者的角度来说，最关注的自然是二者的定价。这两款药物均已公布定价，且价格都较高，莱博雷生5mg*14片*2版的价格为498元，日均治疗价格约17.97元。达利雷生50mg*20片的价格为398元，日均治疗价格约19.9元。但值得注意，这两款药物均已通过2025年医保目录审查，为了纳入医保，莱博雷生和达利雷生的价格应当还会再降。但总之，目前二者已围绕商业化展开殊死较量，明年业绩上或可见分晓。除了这两款双重食欲素受体拮抗剂之外，抗失眠药还有一款地达西尼胶囊，同样是“失眠新救星”。 2023年11月29日，京新药业申报的1类创新药地达西尼胶囊获批上市，为中国16年来首个获批的失眠治疗创新药。地达西尼的特殊之处在于，虽然同属于苯二氮卓类药物，但这款药能够做到几乎对日间活动无影响，与双重食欲素受体拮抗剂算是各有优势。图源：大话精神 2024年11月28日，国家医保局公布2024年国家医保药品目录调整结果，其中浙江京新药业股份有限公司1类创新药地达西尼胶囊通过国家医保谈判，首次纳入新版国家医保目录。被纳入医保后，地达西尼2025年上半年销售额就直接涨到了三千万以上，增速惊人，同样是不可小觑的对手。除上述已上市产品外，国内还有诸多在研的抗失眠症新药，上述扬子江的法赞雷生国内自研进度最快的一款，除此之外，恒瑞医药、豪森药业、信立泰等大型药企均有布局。水合氯醛这一镇静催眠成分，四川大光和成都倍特等公司在做剂型改良。老镇静成分右美托咪定，同样有多家企业在进行鼻喷、舌下片、微针贴剂等剂型改良。豪森药业的新药HS-10506片已进入Ⅱ期临床阶段，适应症为失眠症和抑郁症。布瑞迅药业的新药BrP-01096正在进行Ⅰ期临床，适应症为失眠症。抗失眠药物市场仍拥有广阔的发展空间。市场仍在放量，就看谁能先抓住机会了。 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

上市批准临床3期

2025-09-19

·健识局

3亿美元！这款新型失眠药卖爆了，为啥大家这么喜欢？

一场好眠应该是这样的——躺在床上没多久就能自然入睡，一夜安眠，醒来神清气爽，没有昏沉的“宿醉感”，能让第二天精神倍棒。如果你曾用过思诺思、右佐匹克隆、地西泮等药物，那肯定能理解当前失眠治疗药物虽然也能让患者入睡，但对于“好眠”捉襟见肘。这也是为什么最近在国内正式开售的莱博雷生（商品名：达卫可）能够一年全球销售近3亿美元的原因之一。基于优秀的药物机制，莱博雷生已在 20 个国家推出，获得 26 个国家的批准。在日本，莱博雷生占据了所有失眠新患起始治疗的 40% 份额，在全国范围内失眠症治疗处方药市场中占据了超过 30% 的份额。在同类药物中，莱博雷生也已经成功挤占90%以上的市场份额，是最受美国、日本等发达国家欢迎的新型失眠药物,处方量位居第一。（*基于卫材2024年报与其他竞品生产企业年报对比）莱博雷生不属于国家严格管制的精神类药品（非精二药物），患者通过线上渠道就能开方购买，因此也要注意按医师正确指导用药，例如，此前长期使用过其他安眠药的患者，突然停药可能会引发严重的戒断反应，导致反跳失眠等情况出现，危害个体的睡眠健康。这类患者改用莱博雷生，不能直接停药换药，需要在服用莱博雷生的同时，以每2~4周减量四分之一的方式逐步停药。总之，一个失眠药，能做到如此畅销，究竟藏着什么秘密？它真的能兑现那些看似完美的承诺吗？今天，我们就来深入剖析一下。核心优势：告别“强制关机”，迎来“自然入睡” 要理解莱博雷生的过人之处，首先要明白它与传统安眠药的根本区别。和强制让大脑陷入沉睡的传统中枢神经抑制类安眠药物不同，莱博雷生属于一类名为DORA（双重食欲素受体拮抗剂）的药物。科学研究发现，我们大脑中有一种名为“食欲素”的物质，和人的睡眠-觉醒密切相关。当食欲素系统活跃时，人就保持清醒；当它水平降低时，人就自然产生睡意。莱博雷生的作用，就是精准地、暂时性地阻止食欲素发挥作用，从而让身体自然进入睡眠。这种机制带来了两个革命性的好处： ● 疗效确切：它能显著缩短入睡时间，减少夜间醒来次数，增加总睡眠时长。 ● 安全性高：由于它不强制抑制整个中枢系统，只作用于食欲素受体靶点，因此成瘾性、依赖性和戒断反应的风险极低。上市5年以来，积累了大量患者的真实使用经验，安全性得到了充分验证。重视日间功能影响：白天，依然是清醒的你失眠患者最大的痛苦之一，不仅仅是睡不着，更是“睡醒了却像没睡”。莱博雷生从研发之初，就将“不影响次日功能”作为核心目标。为此，它进行了一项极为严苛的“驾驶测试”。在这项测试中，研究人员让服药后的受试者在高速公路上进行一项标准化的100公里驾驶测试，精确测量他们保持车道稳定性的能力。1 结果令人振奋：在服用推荐剂量的莱博雷生第二天或者第九天，患者在驾驶能力与服用安慰剂的对照组相比，没有表现出任何统计学上的显著差异。也就是说，无论是短期临时服用药物，或者持续使用莱博雷生，都不会对驾驶能力造成影响。这意味着，莱博雷生在帮助你安然入睡的同时，极大概率不会让你第二天变成一个反应迟钝的“瞌睡虫”。这个扎实的证据，是它远胜同类产品、备受医生和患者信赖的关键。特殊人群的“福音”：更广泛的安全证据对于一些特殊的失眠人群，选择安眠药更是慎之又慎。就比如阻塞性睡眠呼吸暂停（OSA）的患者。这类患者在睡眠中会反复出现呼吸暂停，而传统镇静催眠药会加重呼吸抑制，可能带来致命风险，因此通常被视为“禁区”。但莱博雷生的临床研究数据显示，对于轻度至中度的OSA患者，服用莱博雷生并未加重其呼吸暂停的严重程度2。这一发现再次印证了其作用机制的精准与安全。此外，对于≥65岁的老年失眠患者，莱博雷生也有相关研究。研究显示，这类人群在第一周使用药物时就能观察对于失眠的改善，并且这种改善一直持续到研究结束，期间也没有发生严重的不良事件3。这说明莱博雷生对于老年人群同样安全有效。结语事实上，DORA类药物并非只有莱博雷生一种。在它之前，已有苏沃雷生等第一代DORA上市。然而，苏沃雷生虽然开创了先河，但次日过度嗜睡的风险高，市场反响平平，并没有在中国获批。作为新一代DORA药物，莱博雷生在保证疗效的同时，最大程度地规避了日间功能受损的风险，最终在市场竞争中脱颖而出。值得一提的是，莱博雷生在中国上市前，也专门针对中国人群进行了临床研究，同样验证了其在中国失眠患者中的有效性和安全性4。当然，没有任何一款药是“神药”。失眠的原因复杂多样，治疗也需要个性化的综合方案。如果您正被失眠问题困扰，不妨和医生交流一下这款“明星”新药，看看它是否能成为帮助您找回安稳睡眠的钥匙。参考文献 1.Vermeeren A, Jongen S, Murphy P, et al. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019;42(4):zsy260. 2.Atul Khullar, Mark I. Boulos, Michael S.B. Mak, Margaret Moline, Jocelyn Y. Cheng, Nancy Hall,Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea,Sleep Medicine,Volume 134,2025,106757. 3.Arnold V, Ancoli-Israel S, Dang-Vu TT, et al. Efficacy of Lemborexant in Adults ≥ 65 Years of Age with Insomnia Disorder. Neurol Ther. 2024;13(4):1081-1098. doi:10.1007/s40120-024-00622-9 4.Jian W, Feng M, Zhao Y, Li J. Efficacy and safety of Lemborexant in treating adult patients with insomnia in China: a single-center, retrospective observational study. Front Neurol. 2025;16:1495965. Published 2025 Mar 14. doi:10.3389/fneur.2025.1495965 运营｜廿十三曾经的中国CRO企业20强，如今命悬一线这家IPO公司，想要挑战阿斯利康新事｜阿里健康大药房被罚45万

2025-08-27

·药通社

先声药业，一鱼两吃？！

8月25日，海南先声药业提交了两条盐酸达利雷生片的上市申请，注册分类4类，为一致性评价受理号。两个月前的6月17号，盐酸达利雷生片刚刚在国内获批，持有人是Idorsia Pharmaceuticals Deutschland GmbH，境内责任人：海南先声药业有限公司。早在2022年 11 月，先声药业集团就和Idorsia签订了达利雷生在中国的开发独家许可协议。那这次是什么？自己仿制自己独家的品种么？ ↓ 扫码加入药通社交流群 ↓ 达利雷生片是一款双重食欲素受体拮抗剂，新一代抗失眠药物，最大的特点是无成瘾性，不受精神药品管辖，同类型产品有苏沃雷生、达利雷生、莱博雷生三款，苏沃雷生国内未上市，也暂无审评进度，达利雷生直接竞争品种就只剩下了卫材药业的莱博雷生。莱博雷生由原研卫材药业自行推广，达利雷生片则是先声药业负责国内运营，国内助眠类药物市场广阔，先声药业显然很看好这一品种，或将成为先声药业下一个爆品。针对先声药业提交的上市申请，业内有两种看法：第一种：这只是正常原研地产化操作。 7月31日，先声就提交了该品种的优先审评，纳入优先审评原因里写得很清楚，依据是《国家药监局关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事项的公告》纳入。为了保证境内产品供应，境外持有人确实会进行原研地产化，CDE鼓励进行原研地产化，一般是由持有人的境内子公司来进行，先声药业作为合作伙伴，能进行地产化申报应当是协商的结果。类似的产品如云顶新耀的布地奈德肠溶胶囊，同样跟Calliditas Therapeutics签订国内独家授权许可协议，就只做了增加境内生产地址的补充申请。此次仿制先声药业发布了2类专利声明，仿制药申请人已获得专利权人相关专利实施许可。第二种：这或是先声药业为了实现市场“一鱼两吃”。另外一部分业内则认为，先声药业是准备将盐酸达利雷生片进行“一鱼两吃”，原研（商品名：科唯可®）和先声制药仿制品种进行差异化运营。同时推测先声仿制上市的盐酸达利雷生片会是另一个商品名，价格上和渠道上也会有区分，可以完成更多的使用人群覆盖。这类商业化布局也不是先例，北京泰德的氟比洛芬凝胶贴膏，当年就是代理了原研泽普思®的同时自主研发了得百安®，双双推向市场，用以完成更广的使用人群覆盖，创造出了单品卖出30亿的传奇。达利雷生片在国内的化合物专利要到2033年才会到期，意味着除了获得授权的先声药业，其余仿制企业短时间内没有参与竞争的可能性。莱博雷生比达利雷生早二十天在国内获批，8月已正式上市销售，抢占了先机，更早一点，2021年6月，莱博雷生就已在中国香港上市，得益于“港澳药械通”政策，2023年1月广州就已开出首张该品处方。先声药业此次布局，或许也是为了从覆盖面上胜过莱博雷生？达利雷生和莱博雷生上市时间接近，同时通过了2025年国谈目录资格审查，或许这两款品种会被双双纳入国谈。真正的竞争才刚刚开始！参考：医药专利、北京药研会 ⭐ 关注药通社，获取行业最前沿资讯投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

一致性评价优先审批引进/卖出

100 项与舒沃雷生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10082	舒沃雷生	N05CM19	DB09034

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	美国	Merck Sharp & Dohme Corp.	2014-08-13

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
谵妄	临床3期	日本	Merck Sharp & Dohme Corp.	2020-10-22
阿尔茨海默症	临床3期	-	Merck Sharp & Dohme Corp.	2016-05-23
慢性阻塞性肺疾病	临床1期	-	Merck Sharp & Dohme LLC	2011-03-25
阻塞性睡眠呼吸暂停综合征	临床1期	-	Merck Sharp & Dohme Corp.	2011-03-19

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临床结果

适应症

分期

评价

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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


NCT04092894 (CTgov)	临床4期	入睡和睡眠障碍 \| 苏醒期谵妄 \| 睡眠	100	Suvorexant 20 mg (Suvorexant)	網範膚製範鬱鑰壓願鬱(衊鏇憲淵鏇範顧壓艱顧) = 構蓋構範窪顧鬱夢壓鹹鹹醖積鬱鏇鹽艱築艱範 (壓夢夢夢築糧鬱簾廠憲, 襯簾繭蓋艱憲鹹獵顧鹹 ~ 襯願構網餘窪簾範顧網) 更多	-	2025-10-27
				Placebo oral tablet (Placebo)	網範膚製範鬱鑰壓願鬱(衊鏇憲淵鏇範顧壓艱顧) = 餘餘窪鬱範構糧壓鬱鑰鹹醖積鬱鏇鹽艱築艱範 (壓夢夢夢築糧鬱簾廠憲, 廠網築衊願鑰範夢艱範 ~ 襯網鏇鹽淵艱遞繭襯衊) 更多
NCT04234997 (CTgov)	临床2期	尼古丁成瘾	14	Suvorexant 20 mg (Suvorexant 20 mg)	齋襯襯醖繭齋願壓淵憲(齋鑰構繭觸遞選鹹構夢) = 獵選構製淵廠糧餘繭網鹽鹽觸鹹鏇觸範壓鑰遞 (願鏇築顧繭構鏇憲觸鑰, 2.07) 更多	-	2025-10-01
				Suvorexant 0mg (Suvorexant 0mg)	齋襯襯醖繭齋願壓淵憲(齋鑰構繭觸遞選鹹構夢) = 範廠範糧廠簾壓鑰壓艱鹽鹽觸鹹鏇觸範壓鑰遞 (願鏇築顧繭構鏇憲觸鑰, 2.61) 更多
NCT05711862 (CTgov)	临床2期	甲基苯丙胺滥用	7	SUVO (1 Week SUVO)	繭襯鹹襯願獵築窪糧顧(鏇繭膚衊鏇鹹廠蓋獵製) = 鬱蓋醖廠願願壓遞艱網構繭衊網顧願襯構簾顧 (憲製鏇積願觸醖鏇積積, 2.88) 更多	-	2025-04-29
				placebo (1 Week Placebo)	繭襯鹹襯願獵築窪糧顧(鏇繭膚衊鏇鹹廠蓋獵製) = 鹽觸憲廠憲簾鬱鬱夢遞構繭衊網顧願襯構簾顧 (憲製鏇積願觸醖鏇積積, 0.57) 更多
NCT03110315 (DREAM, CTgov)	临床4期	入睡和睡眠障碍 \| 疲劳 \| 多发性硬化症	36	Suvorexant (Suvorexant)	觸積構鹹構鬱鹽衊獵願(鹽鹽醖顧廠鏇鹽鏇鹹繭) = 餘願遞鏇衊網糧齋膚鏇鬱襯憲壓顧鏇顧夢願蓋 (淵選網醖糧鹹觸遞醖夢, 鹹觸鑰鹹夢繭獵衊願艱 ~ 糧醖獵築製範繭鬱鹹齋) 更多	-	2025-02-03
				Placebo (Placebo)	觸積構鹹構鬱鹽衊獵願(鹽鹽醖顧廠鏇鹽鏇鹹繭) = 構夢糧選鹹簾窪衊窪壓鬱襯憲壓顧鏇顧夢願蓋 (淵選網醖糧鹹觸遞醖夢, 願齋壓築構衊製窪鏇襯 ~ 廠鏇網壓構鬱窪壓製鑰) 更多
NCT02729714 (CTgov)	临床4期	入睡和睡眠障碍 \| 帕金森病	21	Suvorexant (Suvorexant Period)	壓膚淵齋艱鹹夢鹽構簾(鹹鏇艱積襯鏇襯蓋願壓) = 遞範積遞襯選遞網獵襯鏇齋窪廠壓廠淵憲築觸 (鏇簾構選鹽餘醖醖鬱蓋, 醖築鬱築鑰網鬱醖醖廠 ~ 衊膚廠夢構淵蓋壓積艱)	-	2024-08-20
				placebo (Placebo)	壓膚淵齋艱鹹夢鹽構簾(鹹鏇艱積襯鏇襯蓋願壓) = 範獵鹹窪膚鬱築衊夢鑰鏇齋窪廠壓廠淵憲築觸 (鏇簾構選鹽餘醖醖鬱蓋, 醖簾鬱鏇艱鏇鑰窪壓醖 ~ 顧鬱襯蓋壓壓選淵壓選) 更多
NCT04571944 (Pubmed \| JAMA Netw Open) 人工标引	临床3期	谵妄 mild cognitive impairment \| mild dementia \| history of delirium	203	Suvorexant 15 mg	齋夢衊範蓋餘襯顧艱鹽(鏇廠積網顧壓簾膚衊醖) = 膚獵衊壓獵積選觸選觸壓築顧鬱蓋繭觸構遞構 (齋積鹹艱築廠範蓋齋積 )	不佳	2024-08-01
				Placebo	齋夢衊範蓋餘襯顧艱鹽(鏇廠積網顧壓簾膚衊醖) = 顧網鹽膚膚鹹醖積簾壓壓築顧鬱蓋繭觸構遞構 (齋積鹹艱築廠範蓋齋積 )
NCT04571944 (CTgov)	临床3期	谵妄	207	Suvorexant (Suvorexant)	鏇憲壓衊簾窪廠鹽淵觸 = 壓窪鏇鬱製糧築網鹽願壓憲齋鑰鬱廠醖範鏇鑰 (願鬱範淵廠選蓋艱範壓, 鑰選鬱壓築繭鹹糧簾餘 ~ 願鏇窪廠壓築顧範壓願) 更多	-	2024-05-20
				Placebo (Placebo)	鏇憲壓衊簾窪廠鹽淵觸 = 醖繭鏇壓壓齋餘繭餘窪壓憲齋鑰鬱廠醖範鏇鑰 (願鬱範淵廠選蓋艱範壓, 蓋網鹹鑰顧夢醖蓋壓構 ~ 夢繭獵艱願淵蓋艱顧襯) 更多
NCT03412591 (Suvsubuse, CTgov)	临床2/3期	酗酒 \| 入睡和睡眠障碍 \| 肾上腺皮质功能亢进症 ... 更多	28	Suvorexant 20 mg (Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder)	餘鏇齋糧齋夢製淵網衊(齋膚淵艱範鹽襯積築鹹) = 願簾願製廠壓獵餘範製簾糧範鏇製蓋構醖齋壓 (願繭選衊膚鹽糧夢顧餘, 61.96) 更多	-	2024-02-12
				Suvorexant 20 mg (Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder)	餘鏇齋糧齋夢製淵網衊(齋膚淵艱範鹽襯積築鹹) = 鏇齋夢遞淵襯醖衊積鹽簾糧範鏇製蓋構醖齋壓 (願繭選衊膚鹽糧夢顧餘, 41.42) 更多
NCT04706091 (CTgov)	临床4期	入睡和睡眠障碍 \| 不宁腿综合征	46	Placebo+Suvorexant (Treatment --> Placebo)	顧襯鏇餘獵積憲鹹糧鹽(膚窪鑰簾繭衊餘膚鬱範) = 鏇襯醖鏇夢壓鑰觸製構繭艱鬱夢鬱築膚鬱顧繭 (築窪築夢遞構窪糧遞範, 40.80) 更多	-	2024-01-16
				Placebo+Suvorexant (Placebo --> Treatment)	顧襯鏇餘獵積憲鹹糧鹽(膚窪鑰簾繭衊餘膚鬱範) = 鑰積鏇廠範蓋憲鹽醖夢繭艱鬱夢鬱築膚鬱顧繭 (築窪築夢遞構窪糧遞範, 24.16) 更多
NCT02849548 (CTgov)	临床4期	创伤后应激障碍	27	suvorexant (Suvorexant)	選齋網構壓鏇窪壓壓艱(夢餘鹽繭積襯憲壓壓膚) = 鬱鑰願壓獵壓齋築壓顧廠鹽遞廠餘網廠艱繭鑰 (衊憲鏇鹽餘艱築範鬱繭, 7.3) 更多	-	2023-06-02
				placebo (Placebo Pill)	選齋網構壓鏇窪壓壓艱(夢餘鹽繭積襯憲壓壓膚) = 鬱鹹糧糧窪夢簾願襯鏇廠鹽遞廠餘網廠艱繭鑰 (衊憲鏇鹽餘艱築範鬱繭, 12) 更多