Spravato for Depression: What the FDA Approval Means
A New Class of Antidepressant
In March 2019, the U.S. Food and Drug Administration approved Spravato (esketamine) nasal spray for adults with treatment-resistant depression — marking the first truly new class of antidepressant approved in decades. Unlike traditional antidepressants that primarily target serotonin or norepinephrine, esketamine works on the glutamate system, offering a novel mechanism of action.
How Spravato Is Administered
Spravato is self-administered as a nasal spray under the supervision of a healthcare provider in a certified treatment center. Patients must remain on-site for two hours following each dose due to potential side effects including dissociation and sedation. Treatment begins with twice-weekly sessions, transitioning to weekly and then bi-weekly maintenance sessions over time.
Who Qualifies for Spravato?
Spravato is indicated for adults with major depressive disorder who have not responded to at least two different antidepressant treatments. In 2020, the FDA also approved Spravato for major depressive disorder with acute suicidal ideation or behavior, making it one of the few treatments specifically indicated for this population.
Insurance Coverage
Because Spravato is FDA-approved, it is eligible for insurance coverage under many plans, which distinguishes it from IV ketamine infusions. Prior authorization is typically required. Our team can help you navigate the coverage and prior authorization process.
What Patients Experience
Many patients report noticeable improvement in mood within the first one to two weeks of treatment. Common side effects include dissociation, dizziness, nausea, and sedation during and shortly after administration, which resolve within the two-hour monitoring period.
