A Prospective, Multicenter, Open labeled, Randomized, phase IV clinical study to evaluate safety and efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg / 10 mg plus Melatonin 3 mg film coated tablets in subjects with Primary Insomnia and Sleep Disorder. - NIL

开始日期2024-08-03

申办/合作机构-

NCT06512155

/ Completed临床1期IIT

The Effect of Pregabalin on Perioperative Sleep Quality in Orthopedic Surgery Patients: a Prospective, Randomized, Controlled Study

In today's day of increasing surgical volume, perioperative sleep disorders are an issue that cannot be ignored. They are an important component of perioperative brain protection. Physiologically and psychologically, sleep disorders cause serious damage to patients. The application of pregabalin aims to improve the sleep quality of hand surgery patients, and its anti anxiety effect can also alleviate preoperative anxiety. At the same time, its analgesic mechanism is different from that of opioid drugs, which is also conducive to reducing the use of opioid drugs. Therefore, we propose the following hypothesis: for orthopedic patients with high incidence of postoperative pain and sleep disorders, the use of pregabalin will improve the perioperative sleep quality of such patients.To test the above hypothesis, our research group plans to conduct this prospective, randomized, positive control study.

开始日期2024-07-02

申办/合作机构

四川省人民医院

CTRI/2024/06/069379

/ Not yet recruiting临床2期

Efficacy of Dalk i Layyin (soft massage) and Saut (nasal drops) with Roghan i kaddu in Sahr (Primary Insomnia) A randomised controlled clinical trial - nil

开始日期2024-07-01

申办/合作机构

National Institute of Unani Medicine

100 项与酒石酸唑吡坦相关的临床结果

登录后查看更多信息

100 项与酒石酸唑吡坦相关的转化医学

登录后查看更多信息

100 项与酒石酸唑吡坦相关的专利（医药）

登录后查看更多信息

4,955

项与酒石酸唑吡坦相关的文献（医药）

2025-12-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development and validation of a LC–MS/MS method for the detection of 38 benzodiazepines and 2 Z-drugs in blood

Article

作者: Liu, Yu ; Liu, Xin-Ze ; Guo, Zhen-Shuo ; Yan, Hui ; Xiang, Ping

Benzodiazepines and Z-drugs are commonly used as prescription medications to treat anxiety, epilepsy, insomnia, and alcohol withdrawal syndrome, but their use can lead to tolerance, dependence, and withdrawal reactions if taken against official guidelines. Furthermore, designer benzodiazepines, most of which lack clinical and toxicological data, have entered the illicit drug market as new psychoactive substances and are used for recreational purposes. Their abuse can cause confusion, memory loss, respiratory depression, and even death, especially when combined with other sedative-hypnotics or alcohol. Therefore, new qualitative and quantitative methods for benzodiazepines and Z-drugs are needed for use in forensic and clinical toxicology. This study explored the sample preparation and liquid-liquid extraction using 0.5 mL blood samples and 2 mL of extraction solvent for analysis of these drugs by liquid chromatography-tandem mass spectrometry and multiple reaction monitoring. The benzodiazepines were separated on a pentafluorophenylpropyl (PFPP) column using a mobile phase gradient consisting of A (water, 0.1 % formic acid, 5 % acetonitrile, and 20 mmol/L ammonium acetate) and B (acetonitrile) for 9 min. Validation steps confirmed that the method demonstrated good selectivity, sensitivity (limit of detection: 0.2 ng/mL, lower limit of quantification: 0.5 ng/mL), linearity (R² ≥ 0.99), accuracy, and precision (<20 %). Matrix effects ranged from 35 to 126 %, and recoveries ranged from 17 to 99 %, with 35 compounds having recoveries of more than 50 %. The method was successfully applied for the identification and quantification of benzodiazepines and nonbenzodiazepines in blood samples from 15 authentic poisoning cases. Ten analytes were detected: alprazolam (130.2-575.3 ng/mL), hydroxyalprazolam (2.3-37.3 ng/mL), clonazepam (11.7-773.2 ng/mL), lorazepam (63.4-166.9 ng/mL), 7-aminoclonazepam (17.4-385.3 ng/mL), oxazepam (2.6-964.1 ng/mL), diazepam (227.2 ng/mL), nordazepam(22.4 ng/mL), zolpidem (11.8-64.0 ng/mL), midazolam (70.2 ng/mL), and hydroxymidazolam (162.8 ng/mL).

2025-10-01·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Intranasal empagliflozin modulates synaptic plasticity in migraine: Insights into calcium signaling and epigenetic regulation

Article

作者: El-Ganainy, Samar O ; El-Mezayen, Nesrine S ; Noah, Ashraf A

Migraine is a primary headache disorder without a definite pathophysiology or satisfactory managing strategies. Recently, migraine is primarily a disorder of brain plasticity coupled with altered Ca²⁺ dynamics regulating gene activity and protein expression. Further, epigenetics provided new insight into migraine pathogenesis and therapeutic response elucidation. Sodium-glucose co-transporter-2-inhibitors (e.g., empagliflozin (EMPA)), are a class of antihyperglycemic agents that can cross the blood-brain-barrier to maintain glucose homeostasis. EMPA possesses myriad pharmacological actions with potential beneficial effects for migraine management. Thus, the current study aimed at exploring EMPA efficacy and mechanisms for treating migraine headache, emphasizing its role in synaptic plasticity and epigenetic mechanisms. Using an animal model of chronic migraine headache, the effect of oral (PO)/intranasal (IN) (brain-targeted)-EMPA versus Zolmitriptan (ZOL) on serum pain marker; Substance-P and migraine symptoms; pain, and photophobia were assessed biochemically and behaviorally. The influence on synaptic plasticity was evaluated by quantifying immunohistochemically stained synaptophysin in brain tissues and assessing calcium/calmodulin-activated-kinases (CaMKIIa)/ Camp-response-element-binding-protein (CREB)/calcitonin-gene-related-peptide (CGRP) or brain-derived-neurotrophic-factor (BDNF) pathways. Further, epigenetic modulation of migraine key genes was evaluated by determining HDAC6, CALCR, and MiR155-5p Moreover, serum glucose and amylin levels were appraised. Both EMPA-PO/IN significantly decreased serum levels of substance-P and pain symptoms, increased brain serotonin levels, synaptophysin expression, and modulated the CaMKIIa/CREB/CGRP/or BDNF pathway. In addition, EMPA-IN, but not ZOL, down-regulated HDAC6, CALCR, and MiR155-5p expressions. Further, unlike EMPA-IN, ZOL, and EMPA-PO demonstrated significant hypoglycemic effects. In conclusion, EMPA-IN shows potential as a novel therapeutic approach for managing migraine headaches by enhancing synaptic plasticity and modulating altered migraine-related epigenetic mechanisms.

2025-09-25·Psychiatry Investigation

The Association of Zolpidem and Suicidality in Psychiatric Outpatients With Insomnia

Article

作者: Kim, Seog Ju ; Lyoo, In Kyoon ; Kim, Yunsu ; Kim, Haein ; Yeo, Hyewon ; Jung, Jin Young ; Yoon, Sujung

Objective Zolpidem is widely prescribed to psychiatric outpatients for the management of insomnia due to its rapid and potent efficacy. However, concerns persist regarding its potential association with suicidal tendencies. While studies have suggested that Z-drugs may influence suicidal behavior in the general population, the specific association of Z-drug use and suicide risk in psychiatric outpatients with insomnia remains unclear. This study aims to investigate the association of zolpidem use and suicidal tendencies in this population.Methods This retrospective study analyzed the medical records of psychiatric outpatients who visited a mental health clinic between January 2018 and December 2022. Of the 6,193 patients assessed, 3,128 (average age: 49.4 years; 36.6% male) reported insomnia, and 364 (11.6%) were prescribed zolpidem. Suicidal tendencies including past suicide attempts, current suicidal ideation, and plans were evaluated in relation to zolpidem use.Results Psychiatric outpatients with insomnia who used zolpidem demonstrated significantly higher rates of suicidal tendencies (χ²=3.97, p=0.046) and suicide attempts (χ²=8.12, p=0.004, 23.6% in zolpidem users) compared to non-users. Logistic regression analysis revealed that zolpidem use was significantly associated with increased suicidal tendencies (β=0.314, standard error=0.137, odds ratio= 1.368, 95% confidence interval [CI] 1.05–1.79, p=0.022), suicidal ideation (β=0.326, standard error=0.138, odds ratio=1.386, 95% CI 1.06–1.82, p=0.018), and suicide attempts (β=0.379, standard error=0.157, odds ratio=1.460, 95% CI 1.07–1.98, p=0.016), even after adjusting for relevant clinical factors.Conclusion This study highlights a significant association of zolpidem use and elevated suicidal tendencies among psychiatric outpatients with insomnia. Although a causal relationship cannot be definitively established, these findings highlight the critical importance of thorough suicide risk assessment and ongoing monitoring in patients prescribed zolpidem.

项与酒石酸唑吡坦相关的新闻（医药）

2025-09-01

·idorsia.com

Idorsia furthers the science of sleep and insomnia at World Sleep 2025

Allschwil, Switzerland – September 1, 2025Idorsia Ltd (SIX: IDIA) continues its commitment to furthering the science of sleep and insomnia with a symposium and eight poster presentations at World Sleep 2025, a global scientific congress bringing the best of sleep medicine and research, in Singapore from September 5-10, 2025. Idorsia’s scientific poster presentations at World Sleep 2025: Real-world data assessment of abuse potential of insomnia therapiesA study to examine the real-world abuse potential of approved and off-label medications used for the treatment of insomnia, using data from the FDA Adverse Event Reporting System (FAERS) database. Real-world data on the abuse potential of medications for the treatment of insomnia. P. Saskin, W.V. McCall, D. Neubauer, A. Crucitti, P.P. Luyet, R. Jaziri, C. Vaillant. Abstract available online Efficacy of daridorexant throughout the night Effect of daridorexant on wakefulness throughout the night: Post-hoc analysis of a randomised, double-blind, active reference (zolpidem) study in patients with insomnia disorder. B. Steiniger-Brach, O. Briasoulis, A. Olivieri, S. Pain, L. Palagini, D. Kunz, P.-A. Geoffroy. Abstract available online Effect of daridorexant on wakefulness throughout the night and morning sleepiness in patients with insomnia disorder. Y. Dauvilliers, G. Zammit, P.-P. Luyet, G. Braunstein, O. Briasoulis, A. Olivieri. Abstract available online Impact of daridorexant in patients with insomnia and additional health conditions Efficacy and safety of daridorexant in women with insomnia disorder during menopausal transition: a subgroup analysis. O. Briasoulis, Z. Schaedel, C. Bassetti, S.M. Bertisch, P. Cassel, S. Palacios, C. Palmay, R. Silvestri, P. Stute, F. Trémollieres, T. Bakker, S. Pain. Abstract available online Efficacy and safety of daridorexant in patients with chronic insomnia disorder and comorbid nocturia. K. Lederer, S. Schoffner, J.-E. Batista Miranda, R. Rowles, A. Olivieri, M. Meinel. Abstract available online Characterization of patients with insomnia disorderThe largest clinical characterization of patients with insomnia disorder to date. Drawing on data from more than 5000 patients screened in the Phase 3 daridorexant program, these analyses provide important insights into the significant and wide-ranging impact of insomnia disorder on objective and subjective nighttime symptoms and daytime functioning. Subgroup analyses by sex and age provide important insights on how insomnia disorder may affect different patient populations. The impact of insomnia disorder on the night and the day: analysis of polysomnography and subjective parameters from a large clinical trial database. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online The impact of insomnia disorder on the night and the day in older and younger adults. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online The impact of insomnia disorder on the night and the day in males and females. M. Fernandes, A. Olivieri, O. Briasoulis, J. Laurent, C. Liguori. Abstract available online Educational symposiumOn Tuesday, September 9, from 12:45 to14:15, Idorsia will host an educational symposium featuring experts David Neubauer (US), Lu Lin (China), Atul Khullar (Canada), Laura Palagini (Italy), and Claudio Liguori (Italy). The symposium will explore the link between insomnia and neurological or psychiatric comorbidities, focusing on the role of orexin. New clinical and real-world data on daridorexant will be presented, alongside practical strategies for managing insomnia in patients with comorbidities through case discussions. The event will conclude with a Q&A and panel discussion to foster expert–attendee dialogue. About World Sleep 2025World Sleep 2025 will be the 18th World Sleep Congress. This congress facilitates an international discussion forum and collaboration among sleep societies and sleep professionals. Sleep clinicians, technologists, trainees, educators, and scientists from around the world will meet to advance knowledge on sleep science, sleep in public health, sleep health, and sleep-wake disorders, their diagnosis and treatments. World Sleep Society seeks to maximize learning both from formal presentations by the leading experts in their fields and from informal discussion groups emphasizing opportunities for networking and member participation. Notes to the editor About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

临床3期

2025-08-19

·医学新视点

入睡加快49%，睡眠中断减少40%！JAMA子刊：新药持续改善失眠

失眠是常见的睡眠障碍，传统的苯二氮卓类和非苯二氮卓类药物虽能改善睡眠，但存在日间嗜睡、依赖风险、耐受性等问题。传统药物通过作用于GABA（γ-氨基丁酸）受体促进睡眠，当前创新药物正在靶向食欲素-2受体（OX2R），食欲素系统是维持过度觉醒的关键通路。选择性阻断OX2R可以启动和延长睡眠，且相较于同时阻断OX1R和OX2R，还可避免对REM睡眠的干扰。 Seltorexant是一款高选择性OX2R拮抗剂。近日，其临床试验结果在JAMA Psychiatry发表，为失眠靶向治疗带来新进展。数据显示，seltorexant在14天治疗中持续改善入睡困难和睡眠维持问题，且疗效和耐受性优于传统药物。截图来源：JAMA Psychiatry 这项随机、双盲、活性药物和安慰剂对照的剂量探索研究在6个国家的55个中心开展，纳入了364名18-85岁的无精神共病的失眠患者（失眠严重程度指数≥15分），患者按1:1:1:1:1的比例随机接受seltorexant（5 mg、10 mg或20 mg）、安慰剂或活性对照药物唑吡坦（根据当地说明书选择5~10 mg剂量），每晚口服一次，治疗持续14天。研究通过多导睡眠图（PSG）评估的核心指标是：首夜睡眠潜伏期（LPS）：从熄灯到持续睡眠≥10分钟的时间；首夜前6小时觉醒时长（WASO-6）。数据显示，seltorexant显著改善了入睡速度和睡眠维持情况。在治疗第1晚，seltorexant 10 mg和20 mg组患者的入睡时间较安慰剂组分别缩短36%和49%，20 mg组患者的入睡时间较活性药物对照组缩短29%。同时，10 mg和20 mg组在前6小时的觉醒时间较安慰剂组分别减少32%和40%，seltorexant不同剂量组在第 1 晚的WASO-6改善程度与唑吡坦相当。更令人振奋的是，seltorexant的这种改善效果持续到第13晚，而活性药物对照组的疗效则有所减弱。具体而言，相比活性药物对照组，seltorexant 10 mg和20 mg组的入睡时间缩短30%和28%，20 mg组的觉醒时间减少31%。从睡眠结构来看，seltorexant 10 mg和20 mg可同步改善REM与非REM睡眠，未出现DORAs类药物会导致的REM睡眠代偿性增加现象，提示其独特机制优势。 Seltorexant的耐受性优于传统药物，治疗中出现的不良事件（TEAE）发生率为33.8%，低于安慰剂组（49.3%）和活性药物对照组（42.5%）。大多数TEAE为轻度或中度。Seltorexant组患者的嗜睡发生率稍高：20 mg组为5.6%，5 mg组为1.4%，10 mg组未发生，相比之下，活性药物对照组为5.5%，安慰剂组为1.3%。老年人群（65-85岁）对seltorexant耐受良好，不良事件率39.5%，低于活性药物对照组的48.0%和安慰剂组的52.0%。这项研究为失眠患者带来了新的治疗希望。目前，这款疗法正处于3期研发阶段，期待这款疗法能让更多人睡个好觉。点击文末“阅读原文/Read more”，即可访问期刊官网阅读完整论文。推荐阅读 NEJM失眠管理综述：一类疗法无需吃药，效果相当；四大类药物也可选择睡得不好，至少与13种疾病相关！《自然-医学》：关注可穿戴设备睡眠监测封面图来源：123RF 参考资料 [1] Mesens S, Krystal AD, Melkote R, et al. Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial. JAMA Psychiatry. Published online August 13, 2025. doi:10.1001/jamapsychiatry.2025.1999 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

临床结果

2025-08-13

·赛柏蓝

九州通杀入失眠市场！

作者 | 颜色编辑 | 郑瑶九州通入局酸枣仁赛道。 01 九州通布局酸枣仁产业切入失眠治疗赛道 8月12日，九信中药在河北省赞皇县启动酸枣仁初加工项目奠基仪式。这被视为其深化 “道地中药” 全产业链布局的重要举措，核心目标在于强化对睡眠赛道源头资源的掌控能力。这一布局早有铺垫。赛柏蓝搜索发现，今年4月，九信中药已与河北怡诺中药材合资设立赞皇九信道地中药材有限公司，其中九信中药认缴出资510万元，持股比例51%，业务范围涵盖中草药种植、收购等。截图自企查查赞皇县在酸枣仁产业格局中占据举足轻重的地位，作为全国最大的酸枣仁加工产业集群与购销集散地，其已形成了“买全国、卖全国”的产业集群，产业优势显著。如酸枣仁产量连续20余年居全国首位，全县拥有专业化酸枣仁企业300余家、供销加工户1100余户，年加工销售酸枣仁7000余吨。今年3月，九州通与赞皇县政府签订战略合作协议，双方在道地药材全产业链上进行合作，主要围绕GAP基地建设、加工产能升级、科研创新、品牌渠道拓展及医疗健康协同五大领域五个方面展开。酸枣仁是九信中药销售体量最大的药材品种之一，这类兼具治疗失眠功效与较高市场价格的中药材，正受到行业关注。随着人们生活节奏的加快和压力的增大，失眠问题愈发普遍。睡眠经济的爆发性增长，为酸枣仁产业注入了核心动力。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，开源证券在一份研报中提到，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。 02 治疗失眠的「香饽饽」多家药企布局酸枣仁相关产品近年来，九州通在医美、中药等多个领域积极布局。但从自身业务发展看，正面临传统分销业务增长乏力、“第二曲线” 战略失速等困境。 2024年九州通数字化医药分销与供应链业务业务收入1251.59亿元，营收占比82.44%，但同比增速仅0.9%；总代品牌推广业务（CSO）销售收入为192.67亿元，同比下降1.62% 。在这种情况下，开拓新的业务领域迫在眉睫。酸枣仁产业具有高附加值、市场潜力大的特点。随着酸枣仁在睡眠经济市场的需求不断攀升，价格虽有波动但整体处于高位。通过布局酸枣仁产业，九州通有望打造新的利润增长点。以酸枣仁加工为例，从原材料采购、初加工到精深加工，各个环节都存在利润空间。随着品牌渠道的拓展，将酸枣仁产品推向更广阔市场，企业有望进一步提升销售规模与利润水平，实现业务多元化发展。在酸枣仁领域，已经有不少企业布局相关产品。赛柏蓝查询国家药监局官网发现，截至8月13日，以“酸枣仁”为关键词搜索的相关产品批文已经有19条，剂型丰富，包括酸枣仁糖浆、酸枣仁合剂、酸枣仁油滴丸。截图自国家药监局官网米内网数据显示，2022年中国城市实体药店终端，中药饮片TOP20品种中，酸枣仁的销售额已经达到2亿+元。 03 不便宜的酸枣仁需求仍攀升中国睡眠研究会发布的《2025年中国睡眠健康调查报告》显示，中国近半数（48.5%）成年人存在睡眠困扰。睡眠问题呈现年轻化、慢性化、高发化态势，失眠、熬夜等睡眠障碍不仅损害身心健康，还严重影响日常生活与工作。在此背景下，酸枣仁作为临床治疗失眠的常用处方用药，市场需求持续攀升。然而，酸枣仁价格并不亲民。因品质、产地不同，其价格差异较大。常规品类价格在2-5元/克区间，部分低价产品可达0.85元/克。国家医保局在《“酸枣仁”为什么如此引人注目？》一文中指出，2025年版《中国药典》中推荐酸枣仁煎服用量为10-15g，但临床实际应用时，需根据病情轻重调整剂量。有案例显示，重症失眠煎服用量在30g以上。若按照酸枣仁价格2-5元/g计算，一副中药酸枣仁用量10g，7副中药处方仅酸枣仁价格就高达140-350元，此时还未计算处方中其他中药的价格。若酸枣仁用量增加，该中药处方价格将会更高。从市场价格看，赛柏蓝搜索淘宝等购物平台发现，炒酸枣仁的价格基本在1-3元左右。不过，康美中药网数据显示，亳州市场酸枣仁行情下滑，产地正在加工中，新货还没有上市，现市场98货价格在400元/千克左右。尽管价格有所波动，但酸枣仁相关产品整体毛利率较高，部分产品毛利率可达70%以上。例如，甘肃陇神戎发的独家品种酸枣仁油滴丸，2024年其滴丸剂类毛利率达75.62%。 04 「失眠」治疗市场中药/化药竞争激烈失眠治疗市场的竞争已进入白热化阶段，中药与化药两大阵营均有大量产品布局。国内临床常用的安眠药物包括：苯二氮卓类镇静催眠药，如艾司唑仑等；非苯二氮卓类镇静催眠药，如唑吡坦等；褪黑激素受体激动剂，如雷美替胺、阿戈美拉汀等；具有镇静作用的抗抑郁/抗精神病药物，如米氮平、曲唑酮等。目前双食欲素受体拮抗剂作为新型药物正在崛起，今年上半年，卫材的莱博雷生以及先声药业与瑞士Idorsia公司合作的盐酸达利雷生片均作为双食欲素受体拮抗剂在国内获批上市。赛柏蓝搜索发现，在淘宝平台，莱博雷生片（5mg*28片/盒）的价格在522元左右；盐酸达利雷生片国内具体价格尚未公布。国内治疗失眠但尚未上市的药还有扬子江全资子公司海岸药业的法赞雷生片（目前在治疗失眠的临床3期）等，上市进程值得关注。不过，失眠治疗市场中中成药仍占大头。药智网数据显示，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，其中中成药706个，占比94.64%。 2024年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增长了5.22%，达到138.6亿元。中国公立医疗机构终端中成药神经系统疾病TOP20药品包括乌灵胶囊、养血清脑颗粒、舒肝解郁胶囊、强力定眩片等。 2024年中国公立医疗机构终端中成药神经系统疾病用药TOP20产品不过，目前来看失眠治疗率仍处于较低水平。九州通的入局，将会给这一市场带来怎样的变化？ END 内容沟通：郑瑶（13810174402）

并购财报

100 项与酒石酸唑吡坦相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00706	酒石酸唑吡坦	N05CF02	DB00425

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
入睡和睡眠障碍	美国	Cosette Pharmaceuticals, Inc.	1992-12-16

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
注意缺陷障碍伴多动	临床3期	美国	Sanofi	2006-04-01
注意缺陷障碍伴多动	临床3期	加拿大	Sanofi	2006-04-01
躁郁症	临床3期	日本	Astellas Pharma, Inc.	2006-03-01
精神分裂症	临床3期	日本	Astellas Pharma, Inc.	2006-03-01
生物钟紊乱	临床阶段不明	美国	Sanofi	2008-12-01
阿尔茨海默病引起的痴呆症	临床阶段不明	美国	Sanofi	2008-12-01
血管性痴呆	临床阶段不明	美国	Sanofi	2008-12-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03774810 (R01, CTgov)	临床4期	入睡和睡眠障碍	197	Zolpidem Tartrate (QHS-FD (Phase 1))	糧餘襯齋遞簾襯襯衊壓 = 範齋夢築廠蓋窪鏇鑰簾積憲築襯鏇衊廠範蓋獵 (鏇壓繭選齋簾築鬱憲積, 鹽齋鬱遞網衊窪憲窪鬱 ~ 餘醖壓襯鏇獵憲襯鑰膚) 更多	-	2025-05-09
				Zolpidem Tartrate (Partial Reinforcement 1 (PR1) (Phases 2 & 3))	夢夢蓋獵繭糧蓋憲繭餘 = 襯蓋顧遞獵夢製淵廠製顧襯齋艱網構憲獵窪構 (簾淵淵齋選積齋夢鬱構, 窪糧鹽獵襯遞積衊繭遞 ~ 簾鏇願艱襯膚膚蓋簾夢) 更多
NCT04263909 (CTgov)	临床4期	术后疼痛	199	Sublingual Tablet	艱窪觸鑰夢窪鏇餘鬱顧(築鏇襯鑰淵夢獵簾襯淵) = 鏇簾顧遞糧醖餘積鏇廠願築衊蓋鹽醖膚範襯蓋 (選願鬱鑰衊艱夢顧糧願, 2.42) 更多	-	2025-03-30
NCT04468776 (COZI, CTgov)	临床4期	入睡和睡眠障碍	155	Zolpidem+Trazodone (Medication (Zolpidem or Trazodone))	鑰願遞衊積淵壓繭遞積(廠淵壓網鬱衊鏇淵餘觸) = 夢衊願糧醖積鹹膚糧積願壓齋觸廠淵觸齋醖遞 (鏇鬱觸艱簾蓋網選鑰獵, 鏇願廠齋積選築選淵艱 ~ 繭範範窪膚鏇簾壓顧繭) 更多	-	2025-02-24
				Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) (Internet Cognitive Behavioral Therapy for Insomnia (CBT-I))	鑰願遞衊積淵壓繭遞積(廠淵壓網鬱衊鏇淵餘觸) = 鹽選鹽築鹹膚範簾網衊願壓齋觸廠淵觸齋醖遞 (鏇鬱觸艱簾蓋網選鑰獵, 襯鏇鏇選願襯蓋襯糧夢 ~ 鹹鹽築膚齋鑰餘壓鹹廠) 更多
NCT02456532 (CIS2, CTgov)	临床4期	入睡和睡眠障碍	41	placebo (Placebo)	壓繭築齋憲膚範襯糧鹽(遞艱餘範鬱鹽廠積簾蓋) = 鬱夢鹹夢觸廠廠艱獵製餘憲窪製醖築壓構蓋網 (膚繭築憲願蓋艱製願糧, 1.6) 更多	-	2024-03-29
				Zolpidem CR (Zolpidem CR)	壓繭築齋憲膚範襯糧鹽(遞艱餘範鬱鹽廠積簾蓋) = 築醖衊製觸觸襯簾觸鹹餘憲窪製醖築壓構蓋網 (膚繭築憲願蓋艱製願糧, 4.5) 更多
WSC2023	N/A	入睡和睡眠障碍	716	Lemborexant	衊獵齋艱餘壓憲遞鬱艱(膚製窪構糧廠襯觸選鏇) = 餘齋鑰襯夢選簾衊餘窪網製積糧餘鑰簾鹹築餘 (淵襯衊鹹構壓糧襯壓遞 )	积极	2023-10-23
				Trazodone	衊獵齋艱餘壓憲遞鬱艱(膚製窪構糧廠襯觸選鏇) = 觸願餘積窪醖簾餘壓築網製積糧餘鑰簾鹹築餘 (淵襯衊鹹構壓糧襯壓遞 )
NCT02783729 (Study 304, AAN2022)	临床3期	入睡和睡眠障碍	1,006	Lemborexant 5mg	鹽構簾築築夢齋鏇窪遞(糧鏇遞網膚範廠鏇蓋糧) = 夢願構鏇構網鏇蓋淵願顧蓋簾築積鏇淵鏇夢鹽 (繭簾顧遞醖鹽壓製網鬱 ) 更多	-	2022-05-03
				Lemborexant 10mg	鹽構簾築築夢齋鏇窪遞(糧鏇遞網膚範廠鏇蓋糧) = 廠製夢選蓋糧衊鏇獵鹽顧蓋簾築積鏇淵鏇夢鹽 (繭簾顧遞醖鹽壓製網鬱 ) 更多
NCT04720547 (Pubmed \| Sleep Breath)	临床4期	睡眠-觉醒节律障碍 \| 中枢性睡眠呼吸暂停	14	Zolpidem 5 mg	夢窪窪醖淵醖艱醖艱醖(網築襯鬱淵糧夢鹽壓遞) = 夢顧窪範膚觸鏇繭襯築蓋構膚製糧膚衊獵網窪 (觸鏇簾簾窪鹹餘網構淵, 4.4) 更多	积极	2022-03-14
				No medication	夢窪窪醖淵醖艱醖艱醖(網築襯鬱淵糧夢鹽壓遞) = 製遞積蓋範顧網鑰蓋壓蓋構膚製糧膚衊獵網窪 (觸鏇簾簾窪鹹餘網構淵, 7.7) 更多
NCT03075241 (Pubmed \| Neuropsychopharmacology)	临床3期	阿尔茨海默症	62	Zopiclone 7.5 mg/day	簾衊鑰糧網廠淵襯壓鏇(鹽選衊選選鑰艱醖構蓋) = 艱獵築窪膚壓膚夢膚糧鹹糧鹽夢廠窪觸膚艱範 (積蓋餘憲觸願觸築憲鏇, -0.8 ~ 163.2) 更多	-	2021-10-11
Tandem Meetings ASTCT and CIBMTR2020	N/A	多发性骨髓瘤	-	Benzodiazepines	遞積遞鑰鹹網製鑰襯築(醖廠膚膚選廠鬱選餘範) = 繭衊鏇顧築選獵淵觸餘繭觸鏇鬱艱襯醖鏇繭獵 (鬱顧醖顧積顧鑰餘選觸 ) 更多	-	2020-03-01
				Zolpidem	遞積遞鑰鹹網製鑰襯築(醖廠膚膚選廠鬱選餘範) = 遞鑰觸鹹鏇蓋鏇鑰壓淵繭觸鏇鬱艱襯醖鏇繭獵 (鬱顧醖顧積顧鑰餘選觸 ) 更多