Safety profile of ramelteon from the perspective of physicians and pharmacists: a 20-year real-world pharmacovigilance analysis based on the FAERS database.

IF 3.4 2区 医学 Q2 PSYCHIATRY
Jianhong Wu, Yujie Zhou, Linghe Qiu, Liang Liu, Fei Wang, Lili Zhen, Na Li
{"title":"Safety profile of ramelteon from the perspective of physicians and pharmacists: a 20-year real-world pharmacovigilance analysis based on the FAERS database.","authors":"Jianhong Wu, Yujie Zhou, Linghe Qiu, Liang Liu, Fei Wang, Lili Zhen, Na Li","doi":"10.1186/s12888-025-07127-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Ramelteon is the first selective melatonin receptor agonist approved by the FDA, demonstrating significant clinical value in improving sleep latency and sleep quality in patients with insomnia. However, its long-term adverse effects have not been fully evaluated. This study analyzes adverse events associated with ramelteon based on data from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Case reports submitted by physicians and pharmacists were extracted from the FAERS database from the first quarter of 2005 to the third quarter of 2024. Signal detection was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms.</p><p><strong>Results: </strong>A total of 1,150 reports related to ramelteon were analyzed, covering 26 System Organ Classes (SOC) and 537 preferred terms (PT). The main SOCs included psychiatric disorders, general disorders and administration site conditions, and nervous system disorders. Female patients reported higher instances of insomnia, while hangover, feeling drunk, and decreased blood testosterone were more commonly observed in male patients. At the PT level, hangover, initial insomnia, and glossoptosis exhibited the highest signal strengths. Sleep-related adverse events (AE), such as initial insomnia, somnolence, middle insomnia, poor quality sleep, and hypersomnia, were confirmed. Notably, we report for the first time that ramelteon is associated with parasomnia-related AEs, including sleep talking, sleep terror, screaming, and somnambulism.</p><p><strong>Conclusion: </strong>Our study reveals a broad spectrum of AEs associated with ramelteon, including unique sensory experiences (e.g., hangover, derealisation, feeling drunk), reproductive system effects (e.g., decreased libido, priapism), hallucination-related AEs (e.g., visual hallucinations), and rare but clinically significant reactions (e.g., glossoptosis, restless legs syndrome, and photopsia). These findings expand the current understanding of ramelteon's safety and underscore the importance of closely monitoring patients' responses during treatment. Emphasis should be placed on individualized treatment strategies and strengthened pharmacovigilance.</p>","PeriodicalId":9029,"journal":{"name":"BMC Psychiatry","volume":"25 1","pages":"683"},"PeriodicalIF":3.4000,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12235770/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12888-025-07127-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PSYCHIATRY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Ramelteon is the first selective melatonin receptor agonist approved by the FDA, demonstrating significant clinical value in improving sleep latency and sleep quality in patients with insomnia. However, its long-term adverse effects have not been fully evaluated. This study analyzes adverse events associated with ramelteon based on data from the FDA Adverse Event Reporting System (FAERS) database.

Methods: Case reports submitted by physicians and pharmacists were extracted from the FAERS database from the first quarter of 2005 to the third quarter of 2024. Signal detection was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms.

Results: A total of 1,150 reports related to ramelteon were analyzed, covering 26 System Organ Classes (SOC) and 537 preferred terms (PT). The main SOCs included psychiatric disorders, general disorders and administration site conditions, and nervous system disorders. Female patients reported higher instances of insomnia, while hangover, feeling drunk, and decreased blood testosterone were more commonly observed in male patients. At the PT level, hangover, initial insomnia, and glossoptosis exhibited the highest signal strengths. Sleep-related adverse events (AE), such as initial insomnia, somnolence, middle insomnia, poor quality sleep, and hypersomnia, were confirmed. Notably, we report for the first time that ramelteon is associated with parasomnia-related AEs, including sleep talking, sleep terror, screaming, and somnambulism.

Conclusion: Our study reveals a broad spectrum of AEs associated with ramelteon, including unique sensory experiences (e.g., hangover, derealisation, feeling drunk), reproductive system effects (e.g., decreased libido, priapism), hallucination-related AEs (e.g., visual hallucinations), and rare but clinically significant reactions (e.g., glossoptosis, restless legs syndrome, and photopsia). These findings expand the current understanding of ramelteon's safety and underscore the importance of closely monitoring patients' responses during treatment. Emphasis should be placed on individualized treatment strategies and strengthened pharmacovigilance.

从医生和药剂师的角度看ramelteon的安全性:基于FAERS数据库的20年真实世界药物警戒分析。
背景:Ramelteon是FDA批准的首个选择性褪黑激素受体激动剂,在改善失眠患者的睡眠潜伏期和睡眠质量方面显示出显著的临床价值。然而,其长期不良影响尚未得到充分评估。本研究基于FDA不良事件报告系统(FAERS)数据库的数据分析了与瑞美替宁相关的不良事件。方法:从FAERS数据库中提取2005年第一季度至2024年第三季度医师和药剂师提交的病例报告。采用报告优势比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩(MGPS)算法进行信号检测。结果:共分析了与ramelteon相关的1150份报告,涉及26个系统器官分类(SOC)和537个首选术语(PT)。主要的soc包括精神障碍、一般障碍和给药部位状况以及神经系统障碍。女性患者报告失眠的情况较多,而宿醉、感觉醉酒和血液睾酮降低在男性患者中更为常见。在PT水平上,宿醉、初期失眠和光泽度下降表现出最高的信号强度。睡眠相关不良事件(AE),如初期失眠、嗜睡、中期失眠、睡眠质量差和嗜睡。值得注意的是,我们首次报道了ramelteon与睡眠异常相关的ae,包括梦呓、睡眠恐惧、尖叫和梦游症。结论:我们的研究揭示了与ramelteon相关的广谱不良反应,包括独特的感官体验(如宿醉、意识丧失、醉酒感)、生殖系统影响(如性欲下降、阴茎勃起)、幻觉相关的不良反应(如视觉幻觉)和罕见但临床上显著的反应(如光斑减退、不宁腿综合征和失光症)。这些发现扩大了目前对拉美替龙安全性的理解,并强调了在治疗期间密切监测患者反应的重要性。应重视个体化治疗策略,加强药物警戒。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
BMC Psychiatry
BMC Psychiatry 医学-精神病学
CiteScore
5.90
自引率
4.50%
发文量
716
审稿时长
3-6 weeks
期刊介绍: BMC Psychiatry is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of psychiatric disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信