When you hear that a medication is FDA-approved, it can sound reassuring but also vague. You may wonder what studies were done, who qualifies, and how closely the treatment is monitored. The FDA-approval of Spravato is focused on adults living with serious depression that has not improved with standard medications. Reach out to learn more about Spravato and your options for depression treatment at NeuroPsych Wellness Center.
The FDA-approval of Spravato applies to adults in specific situations, always in combination with an oral antidepressant. One group includes people with treatment-resistant depression (TRD), meaning they have tried multiple antidepressants at an adequate dose and duration without enough relief. Another group includes adults with major depressive disorder (MDD) who are experiencing acute suicidal thoughts or behaviors and need more intensive support.
Approval does not mean that Spravato is the right choice for every person who fits these categories. Instead, it means there is evidence that, for some people, the benefits can outweigh the risks when it is used under strict safeguards. Our clinicians still need to review your personal history, other health conditions, and daily responsibilities before recommending it.
One of the most important parts of the FDA-approval of esketamine nasal spray is the requirement that it be used only in clinics that are part of a Risk Evaluation and Mitigation Strategy (REMS) program. This extra layer exists because Spravato can affect blood pressure, thinking, and perception in the short term, and it has a potential for misuse.
Before each visit, our care team reviews recent symptoms, other medications, and any changes in your health. After you self-administer the nasal spray under supervision, you stay in the clinic for observation while the medication takes effect. This monitored time is built into the treatment and is not optional.
These steps are part of the REMS requirements tied to the FDA-approval of Spravato, not just individual clinic policies. They are designed to support safety while still allowing people access to a treatment that works differently from standard antidepressants. After each session, your response is recorded so that dosing and schedules can be adjusted thoughtfully over time.
Along with its indications, the FDA-approval of Spravato therapy includes a boxed warning, which is the strongest type of safety notice the FDA uses. Seeing a boxed warning can be unsettling, but it is meant to give clear, upfront information about key risks so you and your clinician can make informed decisions together.
The boxed warning highlights concerns about:
These warnings do not mean the medication should never be used. Instead, they explain why close monitoring, supervised dosing, and careful screening are built into every Spravato plan. Our clinicians will review your medical history, substance use history, and any heart or blood pressure issues before deciding if this treatment is appropriate.
If you are living with depression that has not responded to multiple medications, learning about this approval can be a useful starting point rather than a final answer. You can bring questions to your clinician about what visits involve, how long treatment might last, and how your safety will be supported. Together, you can decide whether the FDA-approval of Spravato points to a treatment that belongs in your plan or whether other options feel more suitable at this time. Call today to discuss your options.