Resources
Clinical resources and official sources.
Indications, safety information, the approval timeline, and direct links to authoritative SPRAVATO® documentation.
How SPRAVATO® works
SPRAVATO® is the brand name for esketamine, the S-enantiomer of ketamine. It is a non-competitive NMDA-receptor antagonist — a mechanism distinct from standard oral antidepressants, which typically target monoamine (serotonin, norepinephrine, dopamine) systems.
It's delivered as a nasal spray, classified as a Schedule III controlled substance, and manufactured by Janssen, a Johnson & Johnson company.
FDA-approved indications
Per the official prescribing information:
"SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant; Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant."
Limitations of use
- • Effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated.
- • Not approved as an anesthetic.
- • Not approved for pediatric use.
Safety information
SPRAVATO® carries a boxed warning — the FDA's most prominent safety designation. Treatment is conducted in certified settings specifically to manage these risks.
Sedation
Drowsiness and reduced alertness during the monitoring period.
Dissociation
Changes in perception, sensory experience, or sense of self.
Respiratory depression
Slowed or shallow breathing has been reported, particularly with rapid administration of other CNS depressants.
Abuse and misuse
As a Schedule III controlled substance with potential for misuse — managed by the REMS program.
Suicidal thoughts and behaviors
Antidepressants increased the risk in pediatric and young-adult patients in trials. SPRAVATO® is not approved for pediatric use.
Approval timeline
- March 2019
FDA approval for treatment-resistant depression (TRD) — as add-on to an oral antidepressant.
- August 2020
Expanded approval for depressive symptoms in MDD with acute suicidal ideation or behavior.
- January 2025
First and only monotherapy approval for TRD — SPRAVATO® can now be used on its own.