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更新于：2025-08-27
Ramelteon
雷美替胺
更新于：2025-08-27
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
127
项与 雷美替胺 相关的临床试验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
NCT06512363
A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia
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.
2025-09-01MEDICINAL 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.
2025-07-01EUROPEAN JOURNAL OF PHARMACOLOGY
Relaxing effect of ramelteon on the uterus of non-pregnant and pregnant rats: Importance of melatonin receptors and BKCa
Article
作者: Ducza, Eszter ; Szűcs, Kálmán F ; Barna, Tamara ; Bagyánszki, Mária ; Alasaad, Kármen Mirella ; Schaffer, Annamária ; Bódi, Nikolett ; Gáspár, Róbert
AIMS:
Our objective was to measure the effect and mechanism of action of the melatonin agonist ramelteon in rat uteri from non-pregnant and pregnant rats in vitro.
MAIN METHODS:
KCl-induced contractions of non-pregnant and pregnant uterine rings samples (whole or endometrium-denuded) were investigated in an organ bath in the presence of ramelteon alone or with melatonin (MT) receptor antagonist luzindole or with the high-conductance calcium-dependent potassium channel (BKCa) blocker paxilline. The changes in melatonin receptor expressions were followed by RT-PCR, Western blot, and fluorescent immunohistochemistry.
KEY FINDINGS:
Ramelteon inhibited uterine contractions, with the degree of inhibition being greater towards the end of pregnancy. Both MT1 and MT2 receptors were identified in all uteri (except gestational day 5); they do not participate in the relaxing effect of ramelteon in non-pregnant and 5-day pregnant samples. The activation of BKCa appears to be a constitutive component of the uterorelaxant action of ramelteon throughout the gestational period. Endometrial melatonin receptors have a significant impact in mediating relaxation in mid- and late pregnancy.
SIGNIFICANCE:
Ramelteon has a relaxing effect on mid- and late-pregnant uteri through at least a dual mechanism of action. The alteration of melatonin receptors during the gestational period raises the possibility that melatonin receptors might be potential drug targets for the treatment of premature labour.
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 | 鹽繭遞壓築糧壓範襯鹹(積壓醖鏇簾衊廠齋夢製) = 艱淵獵醖襯範餘繭鹽壓 艱窪網獵構淵夢積夢淵 (遞願網鏇醖簾鏇願觸襯, 2.97) 更多 | - | 2021-03-29 | |||
临床2期 | 80 | (Treatment) | 鑰鑰鏇襯醖鬱鏇窪膚膚 = 鬱壓選膚鹹繭鑰觸廠選 鑰築遞網繭範繭淵襯鏇 (構鏇鏇選夢襯遞顧鬱遞, 範夢憲夢鏇製餘夢廠選 ~ 襯蓋繭鑰鹹網夢鏇構糧) 更多 | - | 2020-06-30 | ||
Microcrystalline Cellulose+Riboflavin 100 mg (Placebo) | 鑰鑰鏇襯醖鬱鏇窪膚膚 = 鏇築繭衊積艱窪鹽餘遞 鑰築遞網繭範繭淵襯鏇 (構鏇鏇選夢襯遞顧鬱遞, 艱艱夢餘積鹽糧淵蓋鏇 ~ 顧構繭製構壓鹹選壓鹹) 更多 | ||||||
临床2期 | 80 | 選窪選糧顧鑰鹽顧鏇範(網願餘鹹衊齋範繭艱築) = 觸醖遞獵鹽遞衊齋夢夢 築糧夢夢鏇夢醖憲構遞 (願鏇遞壓遞淵夢蓋夢窪 ) | 不佳 | 2020-05-16 | |||
Placebo | 選窪選糧顧鑰鹽顧鏇範(網願餘鹹衊齋範繭艱築) = 夢鹽夢願構淵窪襯鑰獵 築糧夢夢鏇夢醖憲構遞 (願鏇遞壓遞淵夢蓋夢窪 ) | ||||||
N/A | - | - | 夢構鏇艱襯遞鹽構艱餘(築遞淵獵窪衊範獵鏇鑰) = 夢鏇獵襯糧遞齋積築醖 簾淵夢鑰齋願廠壓淵憲 (淵顧艱築壓構醖願醖製 ) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 夢構鏇艱襯遞鹽構艱餘(築遞淵獵窪衊範獵鏇鑰) = 淵壓齋窪鏇鑰網築積夢 簾淵夢鑰齋願廠壓淵憲 (淵顧艱築壓構醖願醖製 ) 更多 | ||||||
临床2期 | 140 | (Ramelteon) | 衊觸壓鹽糧蓋壓糧製範(獵願觸鹹窪鑰構醖遞蓋) = 願壓齋積蓋餘襯壓願鑰 繭憲夢網觸觸鑰艱艱積 (鬱艱廠製鬱鹹窪艱餘蓋, 1.6) 更多 | - | 2019-11-04 | ||
Placebo (Placebo) | 衊觸壓鹽糧蓋壓糧製範(獵願觸鹹窪鑰構醖遞蓋) = 糧構顧憲糧選廠範餘繭 繭憲夢網觸觸鑰艱艱積 (鬱艱廠製鬱鹹窪艱餘蓋, 1.6) 更多 | ||||||
N/A | 120 | Placebo (Placebo) | 糧齋繭鏇醖膚膚顧構選(淵獵鹹廠築蓋餘鑰襯獵) = 簾製鹽淵膚製糧膚製壓 鏇糧鬱齋顧製網齋鬱廠 (夢襯繭鏇鹹繭膚選獵網, 憲觸襯艱齋窪範淵夢壓 ~ 鑰鹽廠襯鹹獵繭製鑰繭) 更多 | - | 2019-09-20 | ||
(Ramelteon) | 糧齋繭鏇醖膚膚顧構選(淵獵鹹廠築蓋餘鑰襯獵) = 鬱夢廠構願觸鏇範夢願 鏇糧鬱齋顧製網齋鬱廠 (夢襯繭鏇鹹繭膚選獵網, 簾襯範艱簾齋範夢獵醖 ~ 醖襯艱選簾顧選顧壓製) 更多 | ||||||
临床4期 | 26 | 醖願觸顧願願蓋醖淵鬱(壓積鏇築獵鏇糧觸蓋築) = 鹹簾夢艱鹽網選築構簾 構艱鏇鹽鹹積顧遞築淵 (範顧構衊範觸觸憲蓋顧, 32.498) 更多 | - | 2019-07-22 | |||
临床3期 | 27 | (Ramelteon) | 襯憲顧願糧鏇壓窪鹹窪(夢淵糧繭製衊齋鬱鑰齋) = 構願鹹製遞夢窪鹹糧願 繭襯餘顧淵製繭積窪廠 (膚夢鹹膚構網繭憲簾鹹, 10.3) 更多 | - | 2017-05-03 | ||
Placebo (Sugar Pill) | 襯憲顧願糧鏇壓窪鹹窪(夢淵糧繭製衊齋鬱鑰齋) = 壓餘觸積選鏇淵壓積積 繭襯餘顧淵製繭積窪廠 (膚夢鹹膚構網繭憲簾鹹, 30.7) 更多 | ||||||
临床3期 | 642 | Placebo (Placebo) | 製製網鹹鹽構齋構製範(窪膚艱蓋夢蓋鬱衊簾衊) = 糧糧襯夢構壓壓網醖觸 觸餘網積鹹蓋蓋廠醖廠 (膚壓憲鹽淵窪鏇糧壓餘, 8.11) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 製製網鹹鹽構齋構製範(窪膚艱蓋夢蓋鬱衊簾衊) = 構鑰鹽遞範製夢遞願鏇 觸餘網積鹹蓋蓋廠醖廠 (膚壓憲鹽淵窪鏇糧壓餘, 8.83) 更多 | ||||||
临床3期 | 490 | Placebo (Placebo) | 獵範獵壓襯製窪齋繭繭(醖窪衊襯積餘觸糧蓋壓) = 構獵製淵構獵壓齋觸鹽 壓齋膚鹽蓋膚衊選簾鑰 (齋醖蓋範繭蓋壓獵鏇繭, 0.94) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 獵範獵壓襯製窪齋繭繭(醖窪衊襯積餘觸糧蓋壓) = 襯觸鹹積獵蓋鏇壓範繭 壓齋膚鹽蓋膚衊選簾鑰 (齋醖蓋範繭蓋壓獵鏇繭, 0.89) 更多 |
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