Am J Psychiatry
Real-world data confirm esketamine’s safety over 5 years
Study details: This comprehensive analysis evaluated 58 months of postapproval U.S. safety data for esketamine nasal spray from patient monitoring forms submitted to the esketamine Risk Evaluation and Mitigation Strategy (REMS) program and reports submitted to the Janssen U.S. Global Medical Safety (US-GMS). The study included 58,483 patients and 1,486,213 outpatient treatment sessions from March 2019 to January 2024, focusing on adverse events of interest (sedation, dissociation, increased blood pressure), serious adverse events, suicidality, and drug abuse/misuse.
Results: Sedation and dissociation were reported in 34.7% and 41.0% of sessions, respectively, while increased blood pressure occurred in 0.9%. Serious adverse events were rare (<0.1% in REMS; 0.18% in US-GMS). Suicide rates were lower than background population rates, and 210 cases of all-cause abuse/misuse were identified. No new safety signals emerged over nearly 5 years of real-world use.
Clinical impact: The real-world safety profile of esketamine nasal spray remains consistent with prior clinical trial data and current product labeling. The absence of new safety signals supports ongoing use in treatment-resistant depression, with continued vigilance for dissociation, sedation, and blood pressure changes.
Source:
Sanacora G, et al. (2025, September 10). Am J Psychiatry. Real-World Safety of Esketamine Nasal Spray: A Comprehensive Analysis Almost 5 Years After First Approval. https://pubmed.ncbi.nlm.nih.gov/40926574/