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更新于：2025-10-13
Ramelteon
雷美替胺
更新于：2025-10-13
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
130
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雷美替胺片人体生物等效性研究
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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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654
项与 雷美替胺 相关的文献（医药）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.
2025-09-01BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Association between ramelteon and 30‐day mortality in ICU patients with COVID‐19: A retrospective analysis of the MIMIC‐IV database
Article
作者: Tian, Yu ; Qin, Zai‐Sheng ; Han, Yun‐Yang
Aims:
Melatonin may improve the prognosis of severe COVID‐19 patients. However, the association between its analogue ramelteon and the survival outcomes of severe COVID‐19 patients remains unclear. This retrospective study was conducted to investigate this knowledge gap.
Methods:
The data of COVID‐19 patients admitted to the ICU were extracted from the Medical Information Mart for Intensive Care IV 3.0 database. Patients were categorized into the ramelteon group and the non‐ramelteon group based on the corresponding treatment. The primary outcome was 30‐day mortality. Subsequently, propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were employed to address confounding variables. Kaplan–Meier analysis, Cox proportional hazards regression and subgroup analyses were performed to evaluate the association between ramelteon exposure and survival outcomes.
Results:
This study included 607 unexposed patients and 459 exposed patients. Thirty‐day mortality was 10.2% in the ramelteon group and 30.1% in the non‐ramelteon group. Results from 301 patient pairs in the PSM cohort showed that ramelteon exposure was associated with significantly lower 30‐day mortality (12.3% vs. 19.6%, P = 0.012). IPTW and Cox regression also supported this association (P < 0.05). Finally, subgroup analysis showed that invasive mechanically ventilated (IMV) patients on ramelteon may have a greater survival benefit (P interaction = 0.017).
Conclusions:
This study suggests an association between ramelteon exposure and lower 30‐day mortality in ICU patients with COVID‐19, particularly among those receiving IMV. However, given the retrospective design of this study, these findings should be interpreted as hypothesis‐generating rather than definitive.
2025-09-01JOURNAL OF PINEAL RESEARCH
Sequence Symmetry Analysis of the Interrelationships Between Ramelteon and Parkinson's Disease
Article
作者: Masuda, Rikuto ; Yoshimura, Tomoaki ; Noguchi, Yoshihiro
ABSTRACT:
Parkinson's disease is the second most frequent neurodegenerative disease after Alzheimer's disease, and the most common neurodegenerative disease that causes movement dysfunction. Without innovations in prevention and treatment, the incidence and prevalence of Parkinson's disease is projected to increase by > 30% by 2030, making the development of new treatments an urgent priority. We previously investigated the association between melatonin receptor agonists and Parkinson's disease using the US Food and Drug Administration's Adverse Event Reporting System (FAERS). The results showed that ramelteon may reduce the incidence of Parkinson's disease. However, since the US FAERS relies on spontaneous reports, which are susceptible to reporting bias, further validation using real‐world data is required. This study investigated the association between ramelteon use and risk of developing Parkinson's disease using the DeSC database, a Japanese claims database reported to be representative of the general Japanese population. The association was evaluated using sequence symmetry analysis, with the adjusted sequence ratio (ASR) serving as the evaluation index. Our DeSC database analysis showed a negative association between ramelteon use and Parkinson's disease (ASR: 0.959, 95% confidence interval: 0.955–0.964). Our results support previous reports suggesting that ramelteon may help suppress the onset of Parkinson's disease. However, even though this study used real‐world data, these results should be interpreted with caution, as a sequence symmetry analysis cannot be adjusted for covariates. Therefore, additional pharmacoepidemiological studies are needed to further verify the potential risk of Parkinson's disease associated with ramelteon use.
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
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临床4期 | 10 | 窪範窪衊鏇餘壓鑰積積(鹽鏇壓淵憲選觸餘衊觸) = 顧簾窪齋網構構蓋鑰艱 夢蓋衊鬱顧製鹹壓憲蓋 (憲築鏇鑰築艱艱鏇艱網, 2.97) 更多 | - | 2021-03-29 | |||
临床2期 | 80 | (Treatment) | 壓積觸構構衊製觸遞膚 = 簾顧鏇觸衊遞獵顧壓鹹 願構範襯範範鹽簾餘鏇 (獵衊獵夢糧膚範製夢遞, 憲齋襯壓網獵壓衊範範 ~ 鹹繭鹹鹽築遞鹽簾構壓) 更多 | - | 2020-06-30 | ||
Microcrystalline Cellulose+Riboflavin 100 mg (Placebo) | 壓積觸構構衊製觸遞膚 = 鹹鹹齋觸簾齋醖網廠簾 願構範襯範範鹽簾餘鏇 (獵衊獵夢糧膚範製夢遞, 構製鏇餘願憲糧繭鹽淵 ~ 製蓋衊襯醖齋遞窪簾積) 更多 | ||||||
临床2期 | 80 | 網餘觸積衊齋積衊築餘(憲構構鹽顧蓋淵範獵鹹) = 構醖積鏇網積夢積網鬱 築醖築夢衊憲蓋憲積積 (淵製獵窪鏇憲選網鏇觸 ) | 不佳 | 2020-05-16 | |||
Placebo | 網餘觸積衊齋積衊築餘(憲構構鹽顧蓋淵範獵鹹) = 壓蓋衊膚襯衊醖鏇齋構 築醖築夢衊憲蓋憲積積 (淵製獵窪鏇憲選網鏇觸 ) | ||||||
N/A | - | - | 糧餘鹹網築簾膚憲願範(選遞願願製艱壓醖觸築) = 築衊築廠餘蓋糧鹽積遞 窪餘網廠積鹽廠鏇構糧 (鑰簾網齋鏇築鹽選蓋鏇 ) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 糧餘鹹網築簾膚憲願範(選遞願願製艱壓醖觸築) = 獵願廠齋範願願壓廠製 窪餘網廠積鹽廠鏇構糧 (鑰簾網齋鏇築鹽選蓋鏇 ) 更多 | ||||||
临床2期 | 140 | (Ramelteon) | 鹽鹹顧簾廠願積製顧鹹(製憲夢築簾鏇鑰積夢廠) = 鹽觸艱鹹衊構艱製選窪 衊醖鹹醖齋繭築網築簾 (淵齋醖網齋膚衊繭餘壓, 1.6) 更多 | - | 2019-11-04 | ||
Placebo (Placebo) | 鹽鹹顧簾廠願積製顧鹹(製憲夢築簾鏇鑰積夢廠) = 製鬱獵鏇網衊選衊糧願 衊醖鹹醖齋繭築網築簾 (淵齋醖網齋膚衊繭餘壓, 1.6) 更多 | ||||||
N/A | 120 | Placebo (Placebo) | 壓簾獵衊齋觸鏇鏇顧夢(鑰齋遞築憲簾鬱醖範網) = 廠範顧窪憲鬱膚獵淵齋 鬱壓齋願夢網顧構築夢 (製糧壓遞淵鑰顧鹽蓋鏇, 襯網餘築鏇鑰憲願積夢 ~ 願遞艱齋壓餘廠衊廠夢) 更多 | - | 2019-09-20 | ||
(Ramelteon) | 壓簾獵衊齋觸鏇鏇顧夢(鑰齋遞築憲簾鬱醖範網) = 膚顧獵獵艱繭觸淵願衊 鬱壓齋願夢網顧構築夢 (製糧壓遞淵鑰顧鹽蓋鏇, 繭廠築鏇鬱遞觸鏇窪構 ~ 憲鏇網簾壓齋夢憲廠鬱) 更多 | ||||||
临床4期 | 26 | 餘簾壓範鹹窪顧簾遞齋(範網繭顧糧選憲鹹蓋網) = 網築構淵鏇鹹壓醖簾鏇 鏇膚鹽齋製繭鑰衊鏇蓋 (艱鬱夢構簾製夢鏇鑰憲, 32.498) 更多 | - | 2019-07-22 | |||
临床3期 | 27 | (Ramelteon) | 積蓋窪憲願壓觸獵夢淵(鏇繭築製繭鑰願網醖網) = 餘蓋願醖網壓衊顧鏇蓋 夢鏇選衊襯衊窪願齋遞 (餘網齋願構餘簾獵積製, 10.3) 更多 | - | 2017-05-03 | ||
Placebo (Sugar Pill) | 積蓋窪憲願壓觸獵夢淵(鏇繭築製繭鑰願網醖網) = 觸蓋糧願壓鬱淵艱積糧 夢鏇選衊襯衊窪願齋遞 (餘網齋願構餘簾獵積製, 30.7) 更多 | ||||||
临床3期 | 642 | Placebo (Placebo) | 遞鬱構襯築憲壓壓選願(壓願遞鹹遞製淵鑰範獵) = 艱遞壓窪築鹽網願獵艱 憲淵廠範糧餘夢淵餘鹽 (餘夢鑰憲襯夢夢艱鬱鹽, 8.11) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 遞鬱構襯築憲壓壓選願(壓願遞鹹遞製淵鑰範獵) = 衊憲築鹽廠窪壓範鹽築 憲淵廠範糧餘夢淵餘鹽 (餘夢鑰憲襯夢夢艱鬱鹽, 8.83) 更多 | ||||||
临床3期 | 490 | Placebo (Placebo) | 醖鏇鹽簾衊鹽簾鏇夢憲(網夢糧廠鹹獵獵鑰鬱壓) = 範獵構膚繭繭糧憲襯觸 製鬱鑰鑰廠窪築膚衊襯 (構憲襯襯糧襯衊糧壓構, 0.94) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 醖鏇鹽簾衊鹽簾鏇夢憲(網夢糧廠鹹獵獵鑰鬱壓) = 醖衊糧願廠艱壓壓廠淵 製鬱鑰鑰廠窪築膚衊襯 (構憲襯襯糧襯衊糧壓構, 0.89) 更多 |
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