Over nearly five years of real-world use in the United States, esketamine's safety profile remains consistent with clinical trial findings and product labeling. Among 58,483 patients completing 1,486,213 outpatient sessions, sedation occurred in 34.7% of sessions, dissociation in 41.0%, and increased blood pressure in 0.9%. Serious adverse events were rare, reported in less than 0.1% of sessions in the REMS program and 0.18% in the US-GMS database. Suicide rates were lower than background rates, and 210 incidences of all-cause abuse or misuse were reported. No new safety signals were identified.
Among employed adults with treatment-resistant depression, esketamine nasal spray plus an oral antidepressant led to larger reductions in work productivity loss and related costs than quetiapine extended release plus an oral antidepressant. By week 8, total work productivity loss decreased by 30.3 percentage points with esketamine versus 17.3 with quetiapine, a difference of 13.0 percentage points. Weekly cost savings were $363 for esketamine and $207 for quetiapine. By week 32, reductions were 45.3 and 32.5 percentage points, respectively, with weekly cost savings of $543 versus $390. The results suggest greater benefits for both patient well-being and employer perspectives.