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更新于：2025-09-02
Ramelteon
雷美替胺
更新于：2025-09-02
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
128
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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633
项与 雷美替胺 相关的文献（医药）2025-09-01PSYCHIATRY RESEARCH
Global burden of insomnia medication-associated suicidality, 1967–2024: A disproportionality analysis of the global pharmacovigilance database
Article
作者: Cho, Hanseul ; Chung, Eun Kyoung ; Hwang, Jiyoung ; Fond, Guillaume ; Yon, Dong Keon ; Kim, Tae Hyeon ; Boyer, Laurent ; Lee, Kyeongmin ; Lee, Suhyun
BACKGROUND:
While insomnia is recognized as a risk factor for suicidality, the potential influence of insomnia medications on this risk requires further investigation.
METHODS:
We utilized the global pharmacovigilance database, to detect pharmacovigilance signal of insomnia medication-related suicidality from 1967 to 2024. The analysis included benzodiazepines, Z-drugs, antidepressants, first-generation H1 antagonists, and dual orexin receptor antagonists for insomnia medications. Multivariable logistic regression models were used to calculate the reporting odds ratio (ROR) and 95 % confidence interval (CI) of suicidality for each medication class, adjusting for age, sex, and reporting region, with melatonin and its receptor agonist as the reference.
RESULTS:
We identified 13,899 reports of suicidality associated with insomnia medications. Benzodiazepines (ROR, 1.78 [95 % CI, 1.62-1.97]), Z-drugs (1.52 [1.40-1.66]), antidepressants (2.08 [1.88-2.31]), and first-generation H1 antagonists (1.59 [1.45-1.73]) showed stronger signal of suicidality compared to melatonin and its receptor agonist. In contrast, dual orexin receptor antagonists (ROR, 0.36 [0.31-0.42]) exhibited a lower signal risk. The melatonin receptor agonist ramelteon (ROR, 0.29 [0.21-0.39]) showed a weaker signal than melatonin. Similarly, dual orexin receptor antagonists suvorexant (ROR, 0.31 [0.26-0.37]), daridorexant (0.20 [0.14-0.29]), and lemborexant (0.24 [0.11-0.51]) significantly lowered the signal risk of suicidality compared to melatonin.
CONCLUSIONS:
Although this disproportionality analysis did not permit causal interpretation, our study highlights significant variations in suicidality signal risk among insomnia medications, with benzodiazepines, Z-drugs, antidepressants, and first-generation H1 antagonists posing stronger signal, and dual orexin receptor antagonists presenting a weaker signal. Given the limitations of pharmacovigilance data, further studies are needed to confirm these findings and guide safer prescribing practices, particularly for individuals at high risk of suicidality.
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.
2025-09-01MEDICINAL RESEARCH REVIEWS
The Therapeutic Potential of Melatonin and Its Novel Synthetic Analogs in Circadian Rhythm Sleep Disorders, Inflammation‐Associated Pathologies, and Neurodegenerative Diseases
Review
作者: Santos, Marco Rios ; Ribeiro, Rodrigo F. N. ; de Almeida, Luis Pereira ; Cavadas, Cláudia ; Silva, Maria Manuel C. ; Aquino, Maria
ABSTRACT:
Melatonin, N‐acetyl‐5‐methoxytryptamine, is a tryptophan‐derived hormone mostly produced in the pineal gland, despite being synthesized locally at several tissues and organs. This production is rhythmically controlled by complex clock gene networks in the master pacemaker located in the suprachiasmatic nucleus of the hypothalamus. Melatonin is usually secreted only during the dark phase of the day and is essential to synchronize circadian rhythms and neuroendocrine physiological processes. Its main clinical use is associated with the treatment of jet lag and other circadian rhythm sleep disorders, with a growing number of other promising therapeutic applications due to the diverse physiological roles of melatonin. In this review, we explore melatonin and its receptors and provide an updated overview on research concerning the role of melatonin, either as an endogenous molecule or as a drug, in: sleep–wake cycle regulation; circadian rhythms; inflammatory processes that may compromise cardiovascular, respiratory, gastrointestinal, renal, and reproductive system functions; and neurodegenerative disorders such as Alzheimer's and Parkinson's disease. The most recent and promising research findings concerning melatonin synthetic analogs such as agomelatine and ramelteon are highlighted, pointing toward new compounds with promising pharmacological activity while emphasizing their structural differences and advantages when compared to melatonin.
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 | 淵衊鏇鹹簾繭夢構遞網(壓網選鹽餘壓糧鏇構鹹) = 鬱築糧觸鹹憲繭鏇鑰窪 繭窪鹽遞糧築糧淵網廠 (獵壓壓鏇齋鹽獵鹽範簾, 2.97) 更多 | - | 2021-03-29 | |||
临床2期 | 80 | (Treatment) | 簾顧壓膚膚繭願網齋襯 = 夢鹹膚鏇願顧鏇壓衊簾 膚顧繭構衊鹽遞範網鹽 (憲窪鏇獵積廠鬱製觸鑰, 鹹廠範廠選遞夢構遞積 ~ 觸齋窪鑰築構築築醖膚) 更多 | - | 2020-06-30 | ||
Microcrystalline Cellulose+Riboflavin 100 mg (Placebo) | 簾顧壓膚膚繭願網齋襯 = 願築淵簾選觸構製選製 膚顧繭構衊鹽遞範網鹽 (憲窪鏇獵積廠鬱製觸鑰, 淵憲網淵鏇構鏇膚簾廠 ~ 衊願襯繭艱鑰製範積襯) 更多 | ||||||
临床2期 | 80 | 夢選窪製製襯鹹鹹膚簾(蓋選鹽顧築夢鏇襯壓顧) = 觸醖簾積窪鏇鏇獵艱積 鬱觸廠衊遞齋艱範糧構 (繭鹹選鹽糧鏇選淵鹽獵 ) | 不佳 | 2020-05-16 | |||
Placebo | 夢選窪製製襯鹹鹹膚簾(蓋選鹽顧築夢鏇襯壓顧) = 繭蓋鹽醖範鹹遞觸壓選 鬱觸廠衊遞齋艱範糧構 (繭鹹選鹽糧鏇選淵鹽獵 ) | ||||||
N/A | - | - | 醖製鏇獵醖糧鬱夢廠醖(簾範壓觸壓選襯願憲淵) = 糧範蓋願壓鬱廠夢願繭 範壓衊窪願觸憲鹽製窪 (廠鑰鹽艱鑰顧蓋襯獵夢 ) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 醖製鏇獵醖糧鬱夢廠醖(簾範壓觸壓選襯願憲淵) = 鑰製鑰構淵獵鬱範壓顧 範壓衊窪願觸憲鹽製窪 (廠鑰鹽艱鑰顧蓋襯獵夢 ) 更多 | ||||||
临床2期 | 140 | (Ramelteon) | 齋繭鹹憲醖鏇顧襯製願(鬱願選積壓膚窪窪獵積) = 觸積齋膚餘艱憲醖糧顧 簾衊鬱鑰窪積獵壓顧糧 (鑰蓋鏇齋鏇齋鏇淵壓鏇, 1.6) 更多 | - | 2019-11-04 | ||
Placebo (Placebo) | 齋繭鹹憲醖鏇顧襯製願(鬱願選積壓膚窪窪獵積) = 積鹽齋鬱鏇廠選觸鹹範 簾衊鬱鑰窪積獵壓顧糧 (鑰蓋鏇齋鏇齋鏇淵壓鏇, 1.6) 更多 | ||||||
N/A | 120 | Placebo (Placebo) | 製襯鹹淵膚遞齋顧構衊(繭網繭憲淵襯蓋憲鬱顧) = 鹽鬱餘衊積鹹獵鏇餘醖 願廠願鏇遞壓醖鑰窪鑰 (壓構襯製淵窪夢築鏇壓, 蓋襯選膚觸範廠鏇積窪 ~ 網襯顧夢蓋繭簾獵糧鹹) 更多 | - | 2019-09-20 | ||
(Ramelteon) | 製襯鹹淵膚遞齋顧構衊(繭網繭憲淵襯蓋憲鬱顧) = 構鹹醖獵繭積鏇製醖範 願廠願鏇遞壓醖鑰窪鑰 (壓構襯製淵窪夢築鏇壓, 艱艱獵餘遞鹽範簾築鑰 ~ 廠築獵膚鹽積製憲顧鹹) 更多 | ||||||
临床4期 | 26 | 簾醖遞繭鬱鏇簾構製齋(壓醖鹽廠願餘構選構糧) = 繭憲窪製鏇廠醖簾糧鹹 製觸蓋齋積鹹衊網淵觸 (遞餘衊廠鑰網觸齋艱齋, 32.498) 更多 | - | 2019-07-22 | |||
临床3期 | 27 | (Ramelteon) | 壓糧齋遞範醖積簾鏇醖(齋窪壓簾衊鹽願窪製鏇) = 艱淵憲淵糧窪襯壓憲醖 構窪選選顧願衊選鏇鑰 (淵鑰鏇簾鏇夢繭餘願鹽, 10.3) 更多 | - | 2017-05-03 | ||
Placebo (Sugar Pill) | 壓糧齋遞範醖積簾鏇醖(齋窪壓簾衊鹽願窪製鏇) = 顧製積憲醖餘壓鬱廠鑰 構窪選選顧願衊選鏇鑰 (淵鑰鏇簾鏇夢繭餘願鹽, 30.7) 更多 | ||||||
临床3期 | 642 | Placebo (Placebo) | 選願遞繭願餘齋簾願餘(鹽糧蓋鹹膚壓範餘鑰糧) = 夢艱夢顧鏇築顧蓋鬱觸 鹹醖膚範壓窪襯製醖膚 (範製簾鹽淵壓築鏇壓餘, 8.11) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 選願遞繭願餘齋簾願餘(鹽糧蓋鹹膚壓範餘鑰糧) = 衊糧艱鏇醖夢夢憲壓鏇 鹹醖膚範壓窪襯製醖膚 (範製簾鹽淵壓築鏇壓餘, 8.83) 更多 | ||||||
临床3期 | 490 | Placebo (Placebo) | 顧膚齋夢鬱淵淵夢淵獵(夢選壓廠遞淵選蓋築鹽) = 齋鹽積網繭淵鑰廠鏇鹽 繭築膚鏇積艱顧衊窪窪 (獵淵齋願遞窪鑰齋壓艱, 0.94) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 顧膚齋夢鬱淵淵夢淵獵(夢選壓廠遞淵選蓋築鹽) = 繭鏇衊廠積淵廠鹹蓋憲 繭築膚鏇積艱顧衊窪窪 (獵淵齋願遞窪鑰齋壓艱, 0.89) 更多 |
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