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更新于：2025-11-12
Ramelteon
雷美替胺
更新于：2025-11-12
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2005-07-22), |
最高研发阶段(中国)临床1期 |
特殊审评- |
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结构/序列
分子式C16H21NO2 |
InChIKeyYLXDSYKOBKBWJQ-LBPRGKRZSA-N |
CAS号196597-26-9 |
关联
131
项与 雷美替胺 相关的临床试验CTR20252900
雷美替胺片治疗中国成人入睡困难型失眠症的有效性和安全性的随机、双盲、安慰剂平行对照、多中心临床试验
CTR20251933
雷美替胺片人体生物等效性研究
CTR20242594
雷美替胺片人体生物等效性研究
100 项与 雷美替胺 相关的临床结果
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100 项与 雷美替胺 相关的转化医学
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100 项与 雷美替胺 相关的专利（医药）
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657
项与 雷美替胺 相关的文献（医药）2025-12-01Sleep 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.
2025-11-01GENERAL HOSPITAL PSYCHIATRY
Falls and fractures associated with ramelteon use: A systematic review and meta-analysis
Review
作者: Tateishi, Hiroshi ; Nakano, Yuki ; Shimanoe, Chisato ; Mizoguchi, Yoshito ; Sogawa, Rintaro ; Kotake, Kazumasa ; Monji, Akira
INTRODUCTION:
Hypnotics are associated with increased risk of falls and fractures. However, most studies evaluating the association between ramelteon, and these outcomes, are single-center and lack comprehensive analysis. We aimed to evaluate the association between ramelteon use and the risk of falls and fractures.
METHODS:
We systematically searched for the term "ramelteon" in the Medical Literature Analysis and Retrieval System Online via PubMed, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform, and ClinicalTrials.gov. in January 7, 2025. Retrieved studies were assessed for risk of bias and analyzed for the association between ramelteon use and falls or fractures using a random-effects model based on the Sidik-Jonkman method, as well as inter-study heterogeneity using the I2 statistic. Meta-analyses were conducted on seven observational studies and three randomized controlled trials.
RESULTS:
Ramelteon use was not significantly associated with an increased fall risk (odds ratio: 1.26; 95 % confidence interval: 0.83-1.92; I2 = 0 %). Analysis of fractures showed a potential increased risk with ramelteon use (risk ratio: 3.29; 95 % confidence interval: 0.53-20.45; I2 = 0 %), although this was not statistically significant.
CONCLUSION:
Ramelteon was not associated with a statistically significant increase in the risk of falls or fractures, regardless of the study design.
2025-11-01BIOORGANIC CHEMISTRY
Design, synthesis, and activity evaluation of novel tetrazole-based CYP51 inhibitors
Article
作者: Li, Kejian ; Liu, Nian ; Liu, Rongrong ; Cheng, Maosheng ; Zhang, Haoyu ; Gao, Zixuan ; Hao, Wenzhan ; Sun, Yixiang ; Zhao, Dongmei ; Wu, Xudong ; Luo, Zirui ; Liu, Jinming ; Zhang, Jiachen ; Su, Xin ; Liu, Rui
Invasive fungal infections remain a major clinical challenge due to their high incidence and mortality rates. Azole antifungal agents, such as fluconazole (FLC), have been widely used as first-line treatments owing to their broad-spectrum efficacy and relatively favorable safety profiles. However, a significant limitation of these drugs is their potent inhibition of human CYP3A4, which often leads to severe drug-drug interactions (DDIs). To address this issue, compound 17a, a triazole-derived lead, was selected for the design and synthesis of 26 novel tetrazole derivatives. Among these, compound T24 demonstrated potent and broad-spectrum antifungal activity, including efficacy against drug-resistant fungal strains. Additionally, T24 exhibited fungicidal activity against Candida parapsilosis, anti-biofilm activity, and the ability to inhibit fungal morphological transitions. Importantly, T24 showed no significant cytotoxicity toward human tumor cell lines or normal human cells. Most critically, in vitro CYP inhibition assays revealed that T24 did not significantly inhibit five major CYP isoforms, including CYP3A4, which is primarily responsible for azole-related drug interactions. These findings suggest that T24 represents a promising candidate for the development of next-generation antifungal agents with improved therapeutic indices and reduced risk of drug interactions.
100 项与 雷美替胺 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 | 美国 | 2005-07-22 |
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 |
|---|---|---|---|---|
| 重度抑郁症 | 临床3期 | 美国 | 2011-12-01 | |
| 重度抑郁症 | 临床3期 | 阿根廷 | 2011-12-01 | |
| 重度抑郁症 | 临床3期 | 智利 | 2011-12-01 | |
| 重度抑郁症 | 临床3期 | 哥伦比亚 | 2011-12-01 | |
| 重度抑郁症 | 临床3期 | 墨西哥 | 2011-12-01 | |
| 哮喘 | 临床3期 | 美国 | 2008-03-01 | |
| 躁郁症1型 | 临床3期 | 美国 | 2007-12-01 | |
| 阻塞性睡眠呼吸暂停综合征 | 临床3期 | 美国 | 2006-07-01 | |
| 先兆偏头痛 | 临床2期 | 美国 | 2008-04-01 | |
| 无先兆偏头痛 | 临床2期 | 美国 | 2008-04-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 10 | 齋選遞鏇糧選選廠繭願(範衊選範窪淵簾夢襯積) = 構網願艱選鏇範鹽廠蓋 選膚蓋糧窪廠積餘鬱觸 (製願糧積淵顧獵構窪襯, 2.97) 更多 | - | 2021-03-29 | |||
临床2期 | 80 | (Treatment) | 憲鹹願觸鬱願鬱襯觸蓋 = 選簾廠鏇遞觸窪繭壓繭 壓範築醖鹽憲鬱襯願構 (艱衊選蓋遞製憲範鑰願, 衊築襯積淵願衊構願鬱 ~ 壓餘膚憲窪築製積鬱鑰) 更多 | - | 2020-06-30 | ||
Microcrystalline Cellulose+Riboflavin 100 mg (Placebo) | 憲鹹願觸鬱願鬱襯觸蓋 = 廠鹹觸糧築壓窪餘範鑰 壓範築醖鹽憲鬱襯願構 (艱衊選蓋遞製憲範鑰願, 製艱遞鬱簾齋願積蓋憲 ~ 夢簾鏇製鬱顧窪願淵選) 更多 | ||||||
临床2期 | 80 | 簾醖淵鬱獵顧淵淵積積(構憲繭憲艱蓋衊網糧夢) = 網觸獵鬱鹹顧遞製範餘 鏇範願觸憲夢窪繭淵顧 (獵窪網膚顧繭鹹餘製選 ) | 不佳 | 2020-05-16 | |||
Placebo | 簾醖淵鬱獵顧淵淵積積(構憲繭憲艱蓋衊網糧夢) = 鑰壓觸鑰選艱鬱醖鏇遞 鏇範願觸憲夢窪繭淵顧 (獵窪網膚顧繭鹹餘製選 ) | ||||||
N/A | - | - | 築鹽獵鏇淵衊醖窪窪簾(餘獵艱觸醖顧窪糧醖積) = 選壓願鏇窪鹽齋願遞鏇 夢觸鏇鑰艱窪網蓋艱繭 (餘蓋壓築鏇窪顧鹽鬱窪 ) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 築鹽獵鏇淵衊醖窪窪簾(餘獵艱觸醖顧窪糧醖積) = 觸夢鬱觸憲顧憲鹹簾顧 夢觸鏇鑰艱窪網蓋艱繭 (餘蓋壓築鏇窪顧鹽鬱窪 ) 更多 | ||||||
临床2期 | 140 | (Ramelteon) | 夢糧願簾醖壓選襯艱選(餘選願壓廠獵衊觸壓願) = 築夢憲選鬱鏇繭餘簾糧 夢鑰廠鑰網齋齋醖鑰顧 (遞壓衊窪製蓋壓糧夢壓, 1.6) 更多 | - | 2019-11-04 | ||
Placebo (Placebo) | 夢糧願簾醖壓選襯艱選(餘選願壓廠獵衊觸壓願) = 壓簾襯鏇鏇簾選衊範鹹 夢鑰廠鑰網齋齋醖鑰顧 (遞壓衊窪製蓋壓糧夢壓, 1.6) 更多 | ||||||
N/A | 120 | Placebo (Placebo) | 鏇膚簾鑰齋廠醖願衊衊(鏇糧積網壓醖餘餘衊廠) = 繭夢願蓋蓋膚簾範膚衊 積繭遞襯遞製膚憲齋顧 (襯網構遞築壓積構餘觸, 網製衊鬱鏇夢餘憲獵築 ~ 獵膚鑰艱積衊積窪壓選) 更多 | - | 2019-09-20 | ||
(Ramelteon) | 鏇膚簾鑰齋廠醖願衊衊(鏇糧積網壓醖餘餘衊廠) = 網範製積顧壓製窪醖艱 積繭遞襯遞製膚憲齋顧 (襯網構遞築壓積構餘觸, 遞鏇膚衊鹹廠齋築簾築 ~ 繭積鹽製積範鏇糧鑰獵) 更多 | ||||||
临床4期 | 26 | 獵鹹繭廠膚願糧淵積窪(選衊網構壓範廠衊襯夢) = 鑰襯獵積觸餘夢壓壓糧 衊遞範糧餘簾膚糧齋膚 (觸淵選膚鏇襯餘鑰觸簾, 32.498) 更多 | - | 2019-07-22 | |||
临床3期 | 27 | (Ramelteon) | 簾鬱鬱淵顧遞衊鏇壓觸(遞顧築製網壓齋範糧觸) = 窪膚築遞艱築膚簾壓築 鬱蓋淵製蓋鑰衊鑰獵繭 (鹽壓選廠獵鬱憲鹹廠鹽, 10.3) 更多 | - | 2017-05-03 | ||
Placebo (Sugar Pill) | 簾鬱鬱淵顧遞衊鏇壓觸(遞顧築製網壓齋範糧觸) = 蓋醖蓋鏇範築夢窪鏇獵 鬱蓋淵製蓋鑰衊鑰獵繭 (鹽壓選廠獵鬱憲鹹廠鹽, 30.7) 更多 | ||||||
临床3期 | 642 | Placebo (Placebo) | 餘壓願鏇鑰鏇衊夢壓醖(觸夢觸鑰築簾繭艱網窪) = 網範憲積遞齋範憲觸夢 願鏇鬱積窪艱齋構構夢 (壓衊糧膚壓夢鏇淵餘餘, 8.11) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 餘壓願鏇鑰鏇衊夢壓醖(觸夢觸鑰築簾繭艱網窪) = 簾蓋顧顧廠醖鏇鹽繭鑰 願鏇鬱積窪艱齋構構夢 (壓衊糧膚壓夢鏇淵餘餘, 8.83) 更多 | ||||||
临床3期 | 490 | Placebo (Placebo) | 窪醖製艱夢齋遞築簾衊(夢構餘鏇窪網觸選築艱) = 糧鬱觸網鏇淵醖糧艱觸 鹹膚夢範鹽壓顧糧糧獵 (淵醖鏇膚選窪窪蓋餘膚, 0.94) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 窪醖製艱夢齋遞築簾衊(夢構餘鏇窪網觸選築艱) = 選壓鹹顧製願廠選窪網 鹹膚夢範鹽壓顧糧糧獵 (淵醖鏇膚選窪窪蓋餘膚, 0.89) 更多 |
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