A pilot, parallel group, blinded, placebo controlled, ranDomised pRagmatic clinical trial investigating the Effect of temazepAM on objective and subjective measures of sleep in critically ill adult patients(The DREAM trial)

开始日期2020-10-21

申办/合作机构-

ACTRN12620000581965 / Not yet recruiting临床3期

Temazepam or Melatonin Versus Placebo for the Treatment of INsomnia in Advanced CAncer: A Three Arm, Double Blind, Phase III, Multicentre, Randomised Clinical Trial

开始日期2020-06-01

申办/合作机构

Western Health Ltd.

[+1]

ACTRN12618000727246 / Recruiting临床2期IIT

The effect of psychoactive prescription benzodiazepines (alprazolam, temazepam and diazepam) and concomitant alcohol consumption upon performance and ocular activity whilst driving in adults.

开始日期2018-10-30

申办/合作机构

Swinburne University of Technology

100 项与替马西泮相关的临床结果

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100 项与替马西泮相关的转化医学

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100 项与替马西泮相关的专利（医药）

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972

项与替马西泮相关的文献（医药）

2024-12-01·JAMA Internal Medicine

Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists

Article

作者: Josephson, Karen ; Fung, Constance H. ; Kierlin, Lara ; Kelly, Monica ; Grinberg, Austin ; Badr, M. Safwan ; Moore, Alison A. ; Partch, Lisa ; Naeem, Saadia ; Mitchell, Michael ; Der-Mcleod, Erin ; Zeidler, Michelle ; Cook, Ian A. ; Alessi, Cathy ; Guzman, Andrew ; Dzierzewski, Joseph M. ; Smith, Jason P. ; Martin, Jennifer L. ; Ghadimi, Sara

Importance:

Placebo effects are commonly observed in benzodiazepine receptor agonist hypnotic clinical trials. Clinical guidelines recommend discontinuing benzodiazepine receptor agonist hypnotics (particularly in older adults) and administering cognitive behavioral therapy for insomnia (CBTI) as first-line therapy for insomnia. It is unknown whether a novel intervention that masks the daily dose of benzodiazepine receptor agonist during tapering and augments CBTI with novel cognitive and behavioral exercises targeting placebo effect mechanisms improves benzodiazepine receptor agonist discontinuation.

Objective:

To compare a masked benzodiazepine receptor agonist taper plus augmented CBTI vs an unmasked taper plus standard CBTI.

Design, Setting, and Participants:

This randomized clinical trial conducted at an academic medical center and a Department of Veterans Affairs medical center included adults aged 55 years or older who had used lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem for current or prior insomnia, at doses of less than 8-mg diazepam–equivalent 2 or more nights per week for at least 3 months. Data were collected between December 2018 and November 2023. Data analyses were conducted between November 2023 and July 2024.

Interventions:

Masked taper plus cognitive behavioral therapy-augmented program (MTcap); standard CBTI plus supervised (unmasked) gradual taper (SGT).

Main Outcomes and Measures:

The primary efficacy outcome was percentage achieving benzodiazepine receptor agonist discontinuation 6 months after treatment ended (6-month; intention-to-treat) measured with 7-day self-reported medication logs and for a subset, urine tests. Secondary outcomes were Insomnia Severity Index scores at 1 week posttreatment and 6 months posttreatment, percentage of participants that have discontinued benzodiazepine receptor agonist use at 1 week posttreatment, and benzodiazepine receptor agonist dose and the Dysfunctional Beliefs About Sleep-Medication subscale at 1 week and 6 months posttreatment.

Results:

Of 338 participants who underwent in-depth screening, 188 participants (mean [SD] age, 69.8 [8.3] years, 123 male [65.4%] and 65 female [35.6%]) were randomly assigned to MTcap (n = 92) or SGT (n = 96). Compared with SGT, MTcap resulted in greater benzodiazepine receptor agonist discontinuation at 6 months (MTcap = 64 [73.4%], SGT = 52 [58.6%]; odds ratio [OR], 1.95; 95% CI 1.03-3.70; P = .04) and 1 week posttreatment (MTcap = 76 [88.4%], SGT = 62 [67.4%]; OR, 3.68; 95% CI, 1.67-8.12; P = .001) and reduced frequency of benzodiazepine receptor agonist use (nights/week) at 1 week posttreatment (−1.31; 95% CI, −2.05 to −0.57; P &lt; .001). Insomnia Severity Index improved with no significant between-group difference at follow-up (baseline to 1 week posttreatment, 1.38; P = .16; baseline to 6 months, 0.16; P = .88).

Conclusions and Relevance:

This randomized clinical trial found that a program combining masked tapering with novel cognitive and behavioral exercises targeting placebo mechanisms improved the percentage of long-term benzodiazepine receptor agonist discontinuation compared with standard CBTI plus an unmasked taper.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03687086

2024-11-01·JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Postoperative use of sleep aids and delirium in older adults after major surgery: A retrospective cohort study

Article

作者: Park, Chan Mi ; Kim, Dae Hyun ; Lee, Su Been ; Levin, Raisa

Abstract:

Background:

Sleep aids are commonly prescribed to treat sleep disturbance, a modifiable risk factor for postoperative delirium in older patients. The use of melatonin receptor agonists in the postoperative period has been increasing. The comparative safety of melatonin receptor agonists, zolpidem, and temazepam remains uncertain.

Methods:

This retrospective study included 22,083 patients ≥65 years old who initiated melatonin receptor agonists, zolpidem, or temazepam after major surgery in the Premier Healthcare Database 2009–2018. We performed propensity score‐based overlap weighting and estimated the risk ratio (RR) and risk difference (RD) of postoperative delirium as the primary outcome and a composite of delirium or new antipsychotic initiation, pneumonia, and in‐hospital mortality as secondary outcomes.

Results:

The mean age of the study population was 78 (SD, 7) years and 50% were female. There was no significant difference in the risk of postoperative delirium among patients treated with melatonin receptor agonists (3.4%, reference group), zolpidem (2.9%; RR [95% CI], 0.9 [0.7–1.2]; RD [95% CI] per 100 persons, −0.3 [−1.1 to 0.6]), and temazepam (3.1%; 0.9 [0.7–1.1]; RD [95% CI] per 100 persons, −0.5 [−1.2 to 0.3]). The risks of delirium or new antipsychotic initiation, pneumonia, and in‐hospital mortality were also similar among all groups.

Conclusions:

Melatonin receptor agonists were not associated with a lower risk of postoperative delirium and other adverse outcomes compared with zolpidem and temazepam in older adults after major surgery.

2024-11-01·BMJ Case Reports

Transient global amnesia predisposed by rizatriptan and temazepam

Article

作者: Sanders, Taylor ; Parepalli, Divya ; Garcia-Fernandez, Alejandra ; Szeto, Chun Ho

Transient global amnesia (TGA) is a perplexing neurological condition primarily affecting older adults, characterised by the acute onset of anterograde amnesia. Patients remain oriented to self and symptoms resolve within 24 hours. Before diagnosing TGA, conditions such as transient ischaemic attack and stroke must be excluded. We present a case of a woman in her 60’s who experienced acute onset memory impairment and confusion after taking rizatriptan for migraine and temazepam for insomnia the previous night. Initially treated as an acute ischaemic stroke with tissue plasminogen activator, a thorough neurological examination eventually led to a diagnosis of TGA after other potential causes were ruled out. This case suggests that the combined use of triptans and benzodiazepines may predispose patients to TGA. It also highlights the importance of differentiating TGA from other cerebrovascular diseases in order to reduce patients’ exposure to the thrombolytic agent and the cost of hospitalisation.

项与替马西泮相关的新闻（医药）

2024-07-23

·Outsourcing Pharma

FDA approves Rusan Pharma’s manufacturing facility in India, paving the way for expanded US presence

This significant milestone, achieved following a comprehensive five-day on-site inspection from April 29 to May 3, 2024, marks a critical step in Rusan Pharma’s expansion into the US API market. Dr Kunal Saxena, managing director of Rusan Pharma, said: “This GMP approval by the US Food and Drug Administration underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards.” The Ankleshwar facility’s GMP approval allows Rusan Pharma to significantly enhance its presence in the US market, particularly with its active US Drug Master File (DMF) for specialized APIs such as Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride. Expansion into the US API market The company plans to expand its API portfolio to include Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam. Rusan Pharma's strategic focus includes supplying APIs to US-based companies involved in orphan drugs, addiction treatment, and obesity medications. The US FDA approval will bolster Rusan's capabilities, allowing it to broaden its API product portfolio and increase its footprint in the US pharmaceutical sector. The Ankleshwar facility is also GMP approved by other stringent international agencies, including Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan Pharma has implemented 21-CFR-compliant software solutions such as SAP, Laboratory Information Management System (LIMS), document and quality management systems (DMS & QMS), and electronic logbooks to ensure paperless manufacturing. The company faced and overcame significant challenges in transitioning to these systems, including comprehensive staff training and monitoring. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Strategic international certifications Prior to this approval, Rusan Pharma had established a robust presence in key markets such as Australia, Brazil, Canada, the EU, Mexico, New Zealand, and the United Kingdom. The US FDA's endorsement now enables Rusan to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further strengthens global trust and confidence in Rusan’s products and processes. “Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management,” added Dr. Saxena. “Integration with API enables us to remain competitive while promoting our finished formulations in the global market. It also enables us to be independent from other companies for the supply of critical APIs for manufacturing various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business, and a robust supply of API enables us to achieve a rapid time to market with critical products.” New API manufacturing facility in Pithampur The Ankleshwar manufacturing unit plays a strategic role in Rusan’s manufacturing and distribution network, particularly for critical APIs like fentanyl and buprenorphine. The company’s vision is to ensure the competitive and timely delivery of quality medicines in addiction treatment and pain management sectors. In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ, Madhya Pradesh, with an annual production capacity of up to 400 metric tons, significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection for this new facility by the US FDA and other international inspecting agencies, aiming to further boost its manufacturing capabilities. Rusan Pharma’s continued expansion and adherence to stringent quality standards underscore its commitment to excellence and its strategic vision of becoming a leading global player in the pharmaceutical industry.

上市批准

2024-07-22

·FiercePharma

Rusan Pharma’s API Plant in Ankleshwar Receives (India) USFDA GMP Approval

None Ankleshwar, India – July 22, 2024 – RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of addiction treatment and pain management, recently announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India). The approval, received on May 29, 2024, followed a comprehensive five-day on-site inspection conducted from April 29 to May 3, 2024. This milestone marks a significant achievement for the company as it paves the way for it to enter the US API market. With an active US Drug Master File (DMF) for niche APIs like Eflornithine Hydrochloride Monohydrate and Nalmefene Hydrochloride, Rusan Pharma plans to expand its portfolio with additional APIs, including Apomorphine, Buprenorphine, Naloxone, Naltrexone, Nalbuphine, Sodium Oxybate, Clonazepam, Diazepam, Nitrazepam, Oxazepam, and Temazepam. Speaking on the achievement, Dr. Kunal Saxena, Managing Director of Rusan Pharma, highlights, "This GMP approval by the USFDA underscores our unwavering commitment to maintaining the highest standards of quality and manufacturing excellence, expanding our global presence and credibility. This achievement instils confidence in our partners and clients, reassuring them of our dedication to excellence in producing high-quality APIs that meet the most stringent global standards.” The USFDA approval of the Ankleshwar facility is a critical development in Rusan Pharma's strategy to become a key player in the global pharmaceutical industry. Currently, the company supplies APIs to various US-based companies focused on orphan drugs, addiction treatment, and obesity medications. The approval will further enhance Rusan's capabilities, expand its API product portfolio, and increase its footprint in the growing US pharmaceutical sector. Following on-site audits, Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies such as Health Canada, the European Union (EU), and ANVISA (Brazil). Rusan implemented 21-CFR-compliant software solutions like SAP, Laboratory Information Management System (LIMS), document & quality management systems (DMS & QMS) and electronic logbooks, ensuring a move towards paperless manufacturing. This transition, along with comprehensive staff training and monitoring, posed significant challenges that the company successfully overcame. Before receiving this approval, Rusan Pharma established a robust presence in key markets such as Australia, Brazil, Canada, EU, Mexico, New Zealand, and the United Kingdom. The USFDA's endorsement enables the company to market its APIs to US clients with existing marketing authorizations and those developing new formulations. This approval further bolsters our customers' and regulatory agencies' trust and confidence in us globally. "Our vision is to be a one-stop solution provider in the niche category of addiction treatment and pain management. Integration with API enables us to remain competitive, while promoting our finished formulation in the global market. It also enables us to be independent from other companies for the supply of critical APIs for manufacturing of various finished formulations, especially for narcotic and psychotropic products. Timely delivery of quality medicine is key to any pharmaceutical business. Hence, a robust supply of API enables us to achieve a rapid time to market with critical products" adds Dr Kunal Saxena. Rusan’s Ankleshwar manufacturing unit’s strategic role in its manufacturing and distribution network is underscored by its focus on critical APIs like fentanyl and buprenorphine. The company's vision is to be a comprehensive addiction treatment and pain management provider, ensuring competitive and timely delivery of quality medicines. In November 2023, Rusan Pharma inaugurated its second API manufacturing facility in Pithampur SEZ (Madhya Pradesh, India) with an annual production capacity of upto 400 MT, which is significantly higher than the Ankleshwar plant. By mid-2025, the company plans to seek GMP inspection of this new facility by the USFDA and other international inspecting agencies. This expansion aims to boost Rusan's manufacturing capabilities. About Rusan Pharma Pvt Ltd: Rusan Pharma Pvt Ltd. is an integrated global pharmaceutical company and market leader that specializes in the treatment of Addiction and Pain Management. They offer a complete range of super-specialized products in India and globally. Rusan indigenously develops, manufactures, and markets novel APIs and finished formulations and is one of the few notified companies, which is allowed imports of Narcotic Raw Materials (NRM) such as Thebaine, Oripavine, Codeine and Morphine for the purpose of manufacturing various APIs and finished formulation in India and then re-exporting to global markets. Over the years, Rusan has closely worked with Indian and global institutions such as NACO, UNODC, UNOPS, Global Fund, and Ministries of Health to launch Opioid Substitution Therapy in various emerging markets. Rusan Pharma’s strength lies in innovation of New Drug Delivery Systems (NDDS) such as transdermal patches, implants, depot injections. Rusan was the first company to launch Fentanyl, Buprenorphine and Nicotine Transdermal Patches in India. The company supplies range of products to countries such as India, Canada, Europe, UK, Russia, CIS, South Africa and other South-East Asian countries. Rusan’s API and finished formulation manufacturing facilities hold GMP accreditations such as USFDA, Health Canada, EU, TGA (Australia), SAHPRA (S.Africa), RUSSIA, PIC/S (UKRAINE), ANVISA (Brazil) UAE and many more.

上市批准

2024-01-03

·CPHI制药在线

失眠药物治疗研究进展

关注并星标CPHI制药在线睡眠障碍是指睡眠质量异常或睡眠时发生某些临床症状，如睡眠减少或睡眠过多、睡眠相关运动障碍等，后者包括睡眠行走、睡眠惊恐、不宁腿综合征等。其中最主要最常见的是失眠障碍，以持续睡眠时间过短、早醒以及入睡困难为最主要的3个症状。失眠治疗有躯体治疗(包括药物治疗、物理治疗等) 、心理治疗或者心理治疗联合躯体治疗的综合治疗等。虽然美国内科医师学会将认知行为疗法确定为失眠的一线治疗方法。但由于认知行为疗法存在费用高、咨询时间长、缺乏训练有素的提供者及不能立竿见影等弊端，难以在临床开展。因此，药物治疗依然广泛应用于是失眠治疗。目前推荐在临床常用的治疗失眠药物包括苯二氮䓬受体激动剂、褪黑素及褪黑素受体激动剂、食欲素受体拮抗剂、组胺拮抗剂及抗焦虑、抗抑郁类药物。对单纯失眠患者，一般首选非苯二氮䓬类药物或褪黑素受体激动剂单药治疗，当单药治疗效果不佳时考虑联合不同作用机制的镇静催眠药治疗；对合并情绪障碍患者，需根据症状选择苯二氮䓬类药物或联合具有镇静作用的抗抑郁药、抗精神病药物治疗。 1、苯二氮䓬受体激动剂苯二氮䓬受体激动剂（benzodiazepine receptor agonists，BzRAs）作为临床上最常用于治疗失眠的药物，可分为苯二氮䓬类药物（benzodiazepine drugs，BZDs）与非苯二氮类药物（nonbenzodiazepine drugs，NBZDs）。临床常见用于失眠治疗的BZDs有阿普唑仑、艾司唑仑、劳拉西泮、氯硝西泮等，主要适用于入睡困难和睡眠维持障碍的成年患者，尤其适用于伴有焦虑症的失眠患者。BZDs 通过非选择性结合苯二氮䓬受体，增加γ- 氨基丁酸（gamma aminobutyric acid，GABA）受体的亲和力，促进氯离子内流，导致苯二氮䓬受体所在神经元出现超极化，起到镇静催眠、抗焦虑和肌肉松弛等药理作用。BZDs 可以缩短睡眠潜伏期，减少夜间觉醒，增加总睡眠时间，但深度睡眠时间减少，患者服用后虽然觉得入睡改善、睡眠时间延长，但睡眠质量仍较低。BZDs可能会导致日间思睡、头晕、乏力和认知功能下降，老年患者还可能增加跌倒、骨折的风险。长期使用BZDs 的患者可能形成心理和躯体依赖，且部分患者在停药后出现严重的戒断症状，出现反跳性失眠和焦虑情绪加重，因此长期服用BZDs 的患者需缓慢撤药。美国医师协会在失眠药物治疗指南列出批准治疗失眠的BZDs 有艾司唑仑、氟西泮、夸西泮、替马西泮和三唑仑。 NBZDs通过选择性结合苯二氮䓬受体，抑制睡眠中枢产生镇静催眠作用，但一般不具有抗焦虑作用。临床上常见的NBZDs 有唑吡坦、扎来普隆、佐匹克隆和右佐匹克隆， NBZDs的半衰期较短，白天残留镇静作用少见，尤其唑吡坦和扎来普隆对改善入睡困难效果满意，但对睡眠维持作用不大，佐匹克隆和右佐匹克隆半衰期稍长，对入睡困难和睡眠维持障碍均有作用。 2、褪黑素和褪黑素受体激动剂褪黑素作为重要的生理性睡眠调节因子，其昼夜节律的变化与睡眠节律密切相关。褪黑素由松果体分泌，呈昼少夜多的节律，凌晨2～3点分泌达到高峰，主要作用于下丘脑的褪黑素受体，调节睡眠-觉醒周期。研究发现，外源性褪黑素可能对缩短睡眠潜伏期、增加总睡眠时间有效，但临床观察发现大多数患者对于失眠治疗效果不满意，可能更适合睡眠节律失调的失眠患者。褪黑素主要通过2个高亲和力膜受体MT1和MT2发挥其生理作用。视交叉上核在光-暗循环周期的调控下，通过激活 MT1 和(或MT2) 受体反馈回细胞核以调节睡眠和昼夜节律周期。雷美替胺是首个获准上市的选择性褪黑素受体激动剂，已被 FDA 批准用于治疗失眠，主要改善入睡困难，但在国内未上市。该药物可缩短睡眠潜伏期，增加总睡眠时间，不良反应有头晕、思睡、疲劳、头痛、恶心，加重原发性抑郁症患者的抑郁症状和自杀观念等。阿戈美拉汀是国内仅有的一种褪黑素受体激动剂，具有激动褪黑素受体（MT1/MT2）和5-HT2C受体拮抗的双重机制，研究发现，阿戈美拉汀可改善睡眠维持障碍，增加深睡眠和总睡眠时间、减少入睡后总觉醒时间、提高睡眠效率，因此对有入睡困难患者需联合苯二氮䓬受体激动剂效果更佳。由于该药同时是抗抑郁药，对失眠伴轻中度焦虑抑郁患者可起到改善睡眠和情绪的双重作用，但需注意使用该药物需监测肝功能，对肝功能损害者禁止使用。 3、食欲素受体拮抗剂食欲素( Orexins，OX) 主要由下丘脑外侧、背侧和弯窿区分泌，又称下丘脑分泌素，被称为下丘脑的"觉醒启动区"，可促进食欲且具有促醒作用，对维持长期觉醒很重要，食欲素的生成减少将导致发作性嗜睡和不规则快速眼动睡眠。研究表明，大鼠脑脊髓液内和下丘脑外侧、丘脑内侧的细胞外食欲素A水平呈显著的日节律变化，在黑暗期慢慢上升，在光照期慢慢下降。说明食欲素可调节睡眠-觉醒周期，正常睡眠的控制有赖于下丘脑的食欲素的调节。食欲素能神经元投射最密集的地方是蓝斑核，食欲素A可以通过激活蓝斑去甲肾上腺素能细胞促进觉醒，单胺能和胆碱能神经核是食欲素受体富集区，食欲素神经元在睡眠时保持静息，在即将觉醒前开始放电，在觉醒和睡眠剥夺时活跃。睡眠剥夺通过突触前和突触后机制可以改变食欲素神经元的兴奋性，食欲素可促使前额皮层神经元放电，并通过激活组胺能、去甲肾上腺素能和血清素促进觉醒。食欲素受体拮抗剂只选择性地阻断食欲素受体，食欲素的拮抗剂可改善失眠，提高睡眠质量，没有BZDs类药物的不良反应，却比传统安眠药有更强的药理活性。双食欲素受体拮抗剂( Suvorexant、Almorexant 等) 可通过促进REM睡眠增加总睡眠时间，具有较好的临床疗效和耐受性，已获得FDA批准用于治疗失眠。 4、组胺拮抗剂组胺是一种促进清醒的神经递质，在中枢神经系统中产生于下丘脑的结节乳头核中。因此拮抗组胺受体可促进睡眠。在组胺的4个受体中，H1受体是控制睡眠的关键靶点。有证据表明，敲除 H1 受体的小鼠，在给予 H1 受体拮抗剂多塞平和苯海拉明能够增加 NREM时间和发作次数。而酮替芬则通过增加δ波功率来降低REM 并增加 NREM。从以上数据可推测，组胺拮抗剂对睡眠的影响主要作用于NREM 阶段。但服用抗组胺药可引发抗胆碱能作用，包括发热、脓毒症、视力模糊、口干、便秘、尿潴留、心动过速、肌张力障碍和精神错乱等不良反应。组胺拮抗剂目前对于治疗人类失眠的数据较少，其中多塞平是组胺拮抗剂中用来控制失眠最常用的药物，其能延长 NREM 但减少 REM，但易造成恶心、呼吸道感染等不良反应。 5、抗焦虑、抗抑郁类药物抗焦虑、抗抑郁类药物主要是 5-羟色胺受体( 5-HT1A ) 受体部分激动剂。主要代表有丁螺环酮和坦度螺酮，属于抗焦虑药，由于其对5-HT1A具有良好的亲和力，能够激活突触前5-HT1A受体抑制神经元放电，减少 5-HT1A 的合成与释放，主要用于治疗各种焦虑症以及各种伴发的焦虑症。在治疗焦虑性失眠上，临床使用坦度螺酮较多。该类药物的优点在于镇静作用轻，对认知功能影响较小，无蓄积性，相较于BZDs类药物产生的不良反应更少。但起效相对较慢，为2～4 周。临床研究表明在镇静催眠药上加用坦度螺酮对伴有焦虑症状的失眠患者有更好的治疗作用，联合用药的症状改善效果更好。大部分失眠患者治疗效果不佳的原因可能是忽略了焦虑、抑郁等情感状态的障碍，虽然并无直接证据表明抗抑郁、抗焦虑药物能直接改善失眠，但在由心理、精神因素造成的睡眠问题上，能够起到有效的改善作用，因此在治疗时应充分把握患者病情，必要时应同时考虑抗焦虑、抗抑郁治疗。相关阅读：《失眠障碍新药获批上市，更多创新药很快就到！》参考资料 [1]冯庭宇,许晓伍.失眠症的药物治疗进展[J].世界睡眠医学杂志,2023,10(03):691-696. [2]胡金,韦姗姗,姜海洲等.失眠的药物治疗研究进展[J].中国中药杂志,2023,48(19):5122-5130. [3]沈阳阳,周俊英.失眠药物治疗及进展[J].中国临床医生杂志,2023,51(12):1394-1397. 作者简介：小米虫，药品质量研究工作者，长期致力于药品质量研究及药品分析方法验证工作，现就职于国内某大型药物研发公司，从事药品检验分析及分析方法验证。智药研习社1月直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床结果

100 项与替马西泮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00370	替马西泮	N05CD07	DB00231

研发状态

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	SpecGx LLC	1981-02-27

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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


NCT02153788 (CTgov)	临床4期	入睡和睡眠障碍	44	Temazepam (Temazepam)	鑰夢製積壓構醖淵願繭(蓋顧範壓願鑰糧遞膚製) = 廠選蓋鬱願廠構構鹽顧獵選襯鏇膚淵糧醖衊築 (簾鑰蓋築蓋齋醖壓醖選, 積醖繭顧觸壓窪襯襯鬱 ~ 衊壓窪繭壓顧淵鏇膚餘) 更多	-	2015-03-10
				Placebo (Placebo)	鑰夢製積壓構醖淵願繭(蓋顧範壓願鑰糧遞膚製) = 網鹽糧齋觸繭網廠積構獵選襯鏇膚淵糧醖衊築 (簾鑰蓋築蓋齋醖壓醖選, 觸觸糧範醖遞範鏇窪範 ~ 窪齋範願繭廠齋窪願構) 更多
NCT00465972 (CTgov)	临床4期	入睡和睡眠障碍 \| HIV感染	44	Placebo	鏇簾鹽餘鬱蓋鹽醖選窪(鑰廠壓鏇蓋鏇餘蓋齋壓) = 醖獵築築糧選淵鏇襯夢獵衊遞憲醖窪築鏇鏇繭 (鏇糧觸蓋壓淵淵顧壓壓, 願範窪獵築積鹹製膚網 ~ 鹽夢選襯鹹壓餘淵構憲) 更多	-	2013-07-30
NCT00245661 (Pubmed \| Respir Med)	临床3期	慢性阻塞性肺疾病	14	Temazepam 10mg	獵壓膚築鏇襯憲襯構鑰(範築繭餘襯壓夢壓餘構) = 艱窪鏇膚夢憲膚鑰製憲壓製淵艱廠製糧顧積衊 (憲構蓋願繭糧繭壓鑰鹽 )	-	2010-04-01
				Placebo	獵壓膚築鏇襯憲襯構鑰(範築繭餘襯壓夢壓餘構) = 遞鹽蓋簾製觸衊簾窪製壓製淵艱廠製糧顧積衊 (憲構蓋願繭糧繭壓鑰鹽 )