Wu Jianhong, Zhou Yujie, Qiu Linghe, Liu Liang, Wang Fei, Zhen Lili, Li Na
Affiliated Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation Hospital, Wuxi, 214151, Jiangsu, China.
Chia Tai Tianqing Pharmaceutical Group Co.,Ltd, Nanjing, 210000, Jiangsu, China.
BMC Psychiatry. 2025 Jul 7;25(1):683. doi: 10.1186/s12888-025-07127-1.
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.
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.
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.
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.
雷美替胺是美国食品药品监督管理局（FDA）批准的首个选择性褪黑素受体激动剂，在改善失眠患者的入睡潜伏期和睡眠质量方面具有显著的临床价值。然而，其长期不良反应尚未得到充分评估。本研究基于FDA不良事件报告系统（FAERS）数据库的数据，分析与雷美替胺相关的不良事件。
从2005年第一季度至2024年第三季度的FAERS数据库中提取医生和药剂师提交的病例报告。使用报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）算法进行信号检测。
共分析了1150份与雷美替胺相关的报告，涵盖26个系统器官类别（SOC）和537个首选术语（PT）。主要的SOC包括精神障碍、全身性障碍和给药部位状况以及神经系统障碍。女性患者报告的失眠情况较多，而男性患者中宿醉、感觉醉酒和血睾酮降低更为常见。在PT层面，宿醉、初始失眠和舌下垂表现出最高的信号强度。确认了与睡眠相关的不良事件（AE），如初始失眠、嗜睡、中间失眠、睡眠质量差和嗜睡症。值得注意的是，我们首次报告雷美替胺与异态睡眠相关的AE有关，包括梦呓、夜惊、尖叫和梦游。
我们的研究揭示了与雷美替胺相关的广泛不良事件，包括独特的感官体验（如宿醉、现实解体、感觉醉酒）、生殖系统影响（如性欲减退、阴茎异常勃起）、与幻觉相关的AE（如视幻觉）以及罕见但具有临床意义的反应（如舌下垂、不宁腿综合征和光幻视）。这些发现扩展了目前对雷美替胺安全性的认识，并强调了在治疗期间密切监测患者反应的重要性。应强调个体化治疗策略并加强药物警戒。
