Huang Duoqin, Luo Zixin, Gong Xi, Zou Kang, Peng Yu, Zeng Shaoying
The First Clinical Medical College, Gannan Medical University, Ganzhou, Jiangxi, China.
Department of Psychology, Gannan Medical University, Ganzhou, Jiangxi, China.
Front Psychiatry. 2025 Aug 15;16:1517773. doi: 10.3389/fpsyt.2025.1517773. eCollection 2025.
Zuranolone, the latest oral medication for postpartum depression, was approved in the United States in August 2023. Due to its pharmacokinetic characteristics and rapid onset of action, it is hailed as a breakthrough and enhanced version of the drug. However, there is limited information on adverse drug reactions associated with its use. The primary objective of this study is to assess the post-marketing safety of Zuranolone. This study utilizes the FAERS database to analyze the safety of Zuranolone and provide a reference for clinical safety.
Data on Zuranolone were collected from the FAERS database, covering the period from the third quarter of 2023 to the second quarter of 2024. Disproportionate analysis was used to quantify adverse drug reaction signals associated with Zuranolone and to detect risk signals from the data in the FAERS database. The Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Convolutional Probabilistic Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) were used collectively to detect risk signals.
This study identified 154 reports primarily suspecting Zuranolone and 426 adverse drug events from a total of 1,626,204 adverse event (AE) reports. A total of 142 Preferred Terms (PTs) were identified across 18 System Organ Classes (SOCs). Most reports originated from the United States, with various health professionals and consumers being the main reporters. Adverse reactions following Zuranolone administration predominantly involved Nervous system disorders and Psychiatric disorders. Specific adverse reactions included Somnolence, Dizziness, Fatigue, Sedation, Suicidal ideation, Tremor, Feeling abnormal, Headache, Anxiety, and Nausea. The onset of AEs related to Zuranolone was not prolonged (average onset time of 4 days, with a median onset time of 2 days). Compared to Brexanolone, Zuranolone's adverse reactions were more focused on nervous system diseases, while the latter was primarily associated with psychiatric disorders, General disorders and administration site conditions, and Injury, poisoning and procedural complications. Some adverse reactions related to Zuranolone were reported frequently but were not documented in the prescribing information, including Insomnia, Vertigo, Vision blurred, Migraine, and Muscle twitching.
This study revealed potential AEs of Zuranolone, confirming known safety information about Zuranolone, providing comprehensive data for medical practice and public health decision-making, and laying the foundation for further clinical research. It also provides more comprehensive and updated evidence for the clinical safety of Zuranolone.
祖拉诺龙是最新获批用于治疗产后抑郁症的口服药物，于2023年8月在美国获批。因其药代动力学特性和起效迅速，被誉为药物的突破性升级版。然而，关于其使用相关的药物不良反应信息有限。本研究的主要目的是评估祖拉诺龙的上市后安全性。本研究利用美国食品药品监督管理局不良事件报告系统（FAERS）数据库分析祖拉诺龙的安全性，为临床安全提供参考。
从FAERS数据库收集2023年第三季度至2024年第二季度期间有关祖拉诺龙的数据。采用不成比例分析来量化与祖拉诺龙相关的药物不良反应信号，并从FAERS数据库的数据中检测风险信号。综合使用报告比值比（ROR）、比例报告比值（PRR）、贝叶斯卷积概率神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）来检测风险信号。
本研究从总共1,626,204份不良事件（AE）报告中识别出154份主要怀疑与祖拉诺龙有关的报告以及426起药物不良事件。在18个系统器官分类（SOC）中总共识别出142个首选术语（PT）。大多数报告来自美国，主要报告者包括各类医疗专业人员和消费者。服用祖拉诺龙后的不良反应主要涉及神经系统疾病和精神疾病。具体不良反应包括嗜睡、头晕、疲劳、镇静、自杀意念、震颤、感觉异常、头痛、焦虑和恶心。与祖拉诺龙相关的不良事件发作时间未延长（平均发作时间为4天，中位发作时间为2天）。与布雷沙诺龙相比，祖拉诺龙的不良反应更集中于神经系统疾病，而后者主要与精神疾病、全身疾病和给药部位情况以及损伤、中毒和操作并发症有关。一些与祖拉诺龙相关的不良反应报告频繁，但在处方信息中未记录，包括失眠、眩晕、视力模糊、偏头痛和肌肉抽搐。
本研究揭示了祖拉诺龙潜在的不良事件，证实了有关祖拉诺龙已知的安全信息，为医疗实践和公共卫生决策提供了全面数据，并为进一步的临床研究奠定了基础。它还为祖拉诺龙的临床安全性提供了更全面和最新的证据。
