I’m Dr. Jerry Sanacora, Professor of Psychiatry at the Yale University School of Medicine.

I’m excited to share highlights from our newly published article on the real-world safety of esketamine nasal spray, covering nearly five years since its initial approval for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.

Depression continues to affect over 21 million adults in the United States. Despite the wide range of antidepressants available, many patients do not achieve adequate symptom relief. Esketamine nasal spray can induce rapid antidepressant effects in these patients.

In this study, we analyzed 1.48 million outpatient treatment sessions from more than 58,000 patients, using two complementary safety databases: the REMS database, which captures structured, solicited safety data from treatment sessions, and the Global Medical Safety (GMS) database, which collects a broader range of safety reports from healthcare professionals, patients, literature, and even social media.

We found that sedation and dissociation were reported in 34.7% and 41% of sessions, respectively.

Increased blood pressure occurred in less than 1% of sessions.

Most importantly, serious adverse events were rare – reported in less than 0.1% of sessions in the REMS database and 0.18% in GMS.

We also examined reported rates of suicide. Although 70 deaths by suicide were reported in the GMS, the rate was consistent with the expected background rate for patients with treatment-resistant depression.

Overall, the findings are consistent with the well-established safety profile of esketamine nasal spray, with no new safety signals identified.