ArticleThe international journal of neuropsychopharmacology2024
Real-World Safety of Esketamine Nasal Spray: A Comprehensive Analysis of Esketamine and Respiratory Depression.
Article in The international journal of neuropsychopharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Intranasal administration in modulating depressive-like behavior and reconstructing treatment paradigms through neuroinflammation and neurotrophic pathways.Journal of nanobiotechnology · 2026Review
- Ketamine or Esketamine in Special Populations of Patients With Treatment-Resistant Depression.Medical science monitor : international medical journal of experimental and clinical research · 2026Review
- Intranasal esketamine: real-world clinical practice in treatment-resistant depression and factors associated with treatment response.BMC psychiatry · 2026Article
- Nanomedicine for Depression: From Blood-Brain Barrier Delivery to Neuroimmune-Barrier-Plasticity Network Reprogramming.International journal of nanomedicine · 2026Review
- Esketamine Alleviates Neuropathic Pain and Inflammation via miR-153-3p/AKT3 in CCI Rats.Pain research & management · 2026Article
- Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis.Pharmaceuticals (Basel, Switzerland) · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundEsketamine nasal spray (ESK) is approved, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression in adults and for the treatment of depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. No adverse events (AEs) of respiratory depression were reported in ESK phase 3 clinical trials; however, postmarketing incidents of respiratory depression associated with ESK use have been observed.
methodsThe Janssen Global Medical Safety (GMS) database was reviewed for cases meeting the criteria for respiratory depression with ESK using 47 months of postapproval data, based on the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ) acute central respiratory depression (broad). FDA Adverse Event Reporting System (FAERS), EudraVigilance, and literature searches were performed to identify reports of respiratory depression related to ESK use.
resultsFifty cases, representing 50 patients, in the GMS database met the case definition for respiratory depression; 8 of these had a stronger association with ESK use. The MedDRA preferred term (PT) hypopnea met the threshold for disproportionality with ESK in FAERS. The MedDRA PTs asphyxia, oxygen saturation decreased, respiratory depression, and apnea met the threshold for disproportionality with ESK in EudraVigilance.
conclusionDespite extensive soliciting of AEs for ESK with the US Risk Evaluation and Mitigation Strategy program, respiratory depression is infrequently observed with ESK treatment in the postmarketing setting (estimated incidence: 1 case per 20 000 treatment sessions). Symptoms are manageable and resolve with minor supportive measures. Monitoring for symptoms of respiratory depression, including pulse oximetry, is recommended within the postdose observation period.
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