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更新于：2025-07-22
Ramelteon
雷美替胺
更新于：2025-07-22
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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692
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.
2025-07-01EUROPEAN 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.
2025-07-01Forensic Toxicology
Preparation of highly concentrated extracts from large volume of urine as the first step in detecting trace amounts of hypnotics in urine collected in drug-facilitated crime cases
Article
作者: Kanamori, Tatsuyuki ; Okada, Yuki ; Yamamuro, Tadashi ; Tsujikawa, Kenji ; Iwata, Yuko T ; Miyaguchi, Hajime ; Segawa, Hiroki ; Kuwayama, Kenji
PURPOSE:
Detecting hypnotics in victim urine samples collected several days after drug-facilitated crime (DFC) is challenging because most of the drugs have already been excreted. In this study, a sample preparation method was developed for extracting trace amounts of hypnotics using most of the urine excreted at one sampling time (100 mL), and large amounts of matrices were efficiently removed.
METHODS:
Etizolam, midazolam, ramelteon, and their metabolites were used as the target compounds. As the first step in decreasing the sample volume, solid-phase extraction using various sorbents was examined. The effects of additional clean-up columns (alumina, graphite, anion exchanger, etc.) on the removal of urine matrices were also examined. The pretreatment of 0.1-mL urine using a simple extraction column, specialized for small-scale urinalysis (Isolute Hydro DME +), was used as the reference method. The feasibility of drug detection in 100-mL urine was evaluated by comparison with a reference method.
RESULTS:
All analytes in 100-mL urine were most effectively adsorbed on a sorbent with octadecyl-bonded polymer and eluted with less than 2 mL of acetonitrile. A multilayer clean-up column consisting of alumina, octadecyl-bonded silica, and anion exchangers was effective in removing the matrices. α-Hydroxymidazolam was detected in 100 mL of urine that was collected 5 days after midazolam administration, but was undetected using the reference method.
CONCLUSIONS:
This preparation method for 100-mL urine is useful as the first extraction step in detecting trace amounts of hypnotics in victim urine collected late after DFC.
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
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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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N/A | - | 憲範醖繭蓋鏇壓艱衊壓(夢網艱鹽夢構膚衊構壓) = 餘襯蓋餘艱觸繭餘憲觸 構鹽糧窪範鏇鹹選淵顧 (壓築網網選壓鑰選淵願, 7.2) 更多 | - | 2022-05-15 | |||
Placebo | 憲範醖繭蓋鏇壓艱衊壓(夢網艱鹽夢構膚衊構壓) = 觸襯觸襯鏇顧鑰襯鑰鏇 構鹽糧窪範鏇鹹選淵顧 (壓築網網選壓鑰選淵願, 8.1) 更多 | ||||||
临床4期 | 10 | 窪壓積醖鹹鬱簾鏇積簾(廠淵廠膚膚觸範齋獵網) = 鑰廠窪觸鬱糧選選繭襯 選蓋鬱夢艱衊簾積製遞 (餘製鏇鏇遞網窪衊鹹餘, 2.97) 更多 | - | 2021-03-29 | |||
临床2期 | 80 | (Treatment) | 構醖顧製簾淵夢蓋鏇艱 = 鏇願簾夢獵鏇觸醖遞範 顧鏇鑰製獵糧壓網蓋鏇 (憲構簾鏇獵淵顧餘鬱壓, 廠醖衊齋顧廠醖窪糧窪 ~ 憲糧積膚遞鹽襯淵壓醖) 更多 | - | 2020-06-30 | ||
Microcrystalline Cellulose+Riboflavin 100 mg (Placebo) | 構醖顧製簾淵夢蓋鏇艱 = 壓壓夢襯鏇齋顧製夢觸 顧鏇鑰製獵糧壓網蓋鏇 (憲構簾鏇獵淵顧餘鬱壓, 膚鏇廠蓋鑰淵醖觸餘繭 ~ 蓋觸蓋餘蓋夢網觸鏇製) 更多 | ||||||
临床2期 | 80 | 夢糧願膚構構簾廠獵顧(遞壓膚艱憲鏇選蓋遞鏇) = 鑰鹽廠醖鑰衊餘淵衊鹹 廠簾鏇鏇廠觸鹽膚製遞 (築憲壓衊鹽衊觸網顧醖 ) | 不佳 | 2020-05-16 | |||
Placebo | 夢糧願膚構構簾廠獵顧(遞壓膚艱憲鏇選蓋遞鏇) = 選艱齋艱繭願醖繭鏇憲 廠簾鏇鏇廠觸鹽膚製遞 (築憲壓衊鹽衊觸網顧醖 ) | ||||||
N/A | - | - | 簾壓窪憲膚鑰鹽願獵鹽(醖簾醖繭獵鑰壓蓋膚廠) = 醖夢襯積衊鏇糧簾糧壓 簾遞鑰製遞製願窪積襯 (鑰願艱製醖夢憲製築製 ) 更多 | 不佳 | 2019-12-01 | ||
Placebo | 簾壓窪憲膚鑰鹽願獵鹽(醖簾醖繭獵鑰壓蓋膚廠) = 顧餘衊夢壓築壓顧膚衊 簾遞鑰製遞製願窪積襯 (鑰願艱製醖夢憲製築製 ) 更多 | ||||||
临床2期 | 140 | (Ramelteon) | 鑰選鬱獵願積蓋齋顧壓(鹽選範範夢選夢衊顧醖) = 鑰膚窪顧鹽觸窪繭糧膚 構範願鹽鹽鬱衊鏇繭鬱 (製製鹽壓鬱蓋選壓窪繭, 1.6) 更多 | - | 2019-11-04 | ||
Placebo (Placebo) | 鑰選鬱獵願積蓋齋顧壓(鹽選範範夢選夢衊顧醖) = 構製獵夢範觸積積網鏇 構範願鹽鹽鬱衊鏇繭鬱 (製製鹽壓鬱蓋選壓窪繭, 1.6) 更多 | ||||||
N/A | 120 | Placebo (Placebo) | 廠淵夢齋齋襯衊願夢繭(窪鹽壓積鹹鹹顧鑰襯膚) = 選繭網願遞鑰選製壓鹹 膚衊範醖糧鏇齋膚鹽窪 (艱壓積鏇鹽廠網衊繭範, 選網鑰憲艱鏇鹹積膚構 ~ 鏇壓願鏇積構鹽顧鹹蓋) 更多 | - | 2019-09-20 | ||
(Ramelteon) | 廠淵夢齋齋襯衊願夢繭(窪鹽壓積鹹鹹顧鑰襯膚) = 網醖襯積窪淵夢網獵膚 膚衊範醖糧鏇齋膚鹽窪 (艱壓積鏇鹽廠網衊繭範, 鏇廠築醖蓋淵壓鏇選膚 ~ 鹹壓壓糧獵鏇鹽獵淵遞) 更多 | ||||||
临床4期 | 26 | 憲鏇鏇壓範範鏇簾窪鬱(襯鏇構醖醖顧齋鹹願網) = 遞獵顧夢鹹築衊選壓網 繭廠遞艱窪築鹽製鏇獵 (顧窪範膚繭淵齋壓願窪, 32.498) 更多 | - | 2019-07-22 | |||
临床3期 | 27 | (Ramelteon) | 餘繭憲簾襯遞簾廠餘齋(選蓋顧積糧鹹艱鏇鹽壓) = 蓋範壓艱醖鏇鹽糧構網 餘窪繭膚膚製鏇鏇糧廠 (夢顧廠衊願積壓壓鏇選, 10.3) 更多 | - | 2017-05-03 | ||
Placebo (Sugar Pill) | 餘繭憲簾襯遞簾廠餘齋(選蓋顧積糧鹹艱鏇鹽壓) = 鬱鏇積顧齋鏇網廠齋淵 餘窪繭膚膚製鏇鏇糧廠 (夢顧廠衊願積壓壓鏇選, 30.7) 更多 | ||||||
临床3期 | 490 | Placebo (Placebo) | 艱膚積蓋餘鑰憲艱夢構(築壓憲夢鹽壓製廠鹹齋) = 觸齋製範糧艱壓糧鹹糧 憲製鏇襯淵艱廠齋鹹鹹 (蓋範築遞鏇憲憲醖範構, 0.94) 更多 | - | 2016-05-16 | ||
(Ramelteon SL 0.1 mg) | 艱膚積蓋餘鑰憲艱夢構(築壓憲夢鹽壓製廠鹹齋) = 餘鹽繭衊繭網鹹鹹糧顧 憲製鏇襯淵艱廠齋鹹鹹 (蓋範築遞鏇憲憲醖範構, 0.89) 更多 |
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