Understanding the FDA-approval of SPRAVATO helps you make your treatment decisions with more confidence. SPRAVATO (esketamine) is a prescription nasal spray available only to adults who meet specific clinical criteria.
At our certified clinic, we administer SPRAVATO under direct supervision and follow all safeguards required by the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). We guide you through each step to ensure your treatment is safe, compliant, and fully supported.
The Food and Drug Administration (FDA) has authorized SPRAVATO for only two specific medical situations, and understanding these indications helps you and your clinician decide whether this treatment aligns with your history and goals. You may qualify if you have treatment-resistant depression (TRD) as an adult, where SPRAVATO can be used on its own or alongside an oral antidepressant. You may also qualify if you have major depressive disorder (MDD) with acute suicidal thoughts or behaviors, a situation in which SPRAVATO must be paired with an oral antidepressant.
These FDA indications determine who may qualify for the use of SPRAVATO and when it must be combined with an oral antidepressant. At Cedar Park TMS, we carefully review your history, confirm your eligibility, and document the correct indication before your treatment begins so you can move forward with clarity and confidence.
You receive your SPRAVATO doses as a nasal spray in our clinical setting, following all FDA-approved guidelines. You administer the spray yourself while one of our clinicians supervises, and then you remain in the clinic for at least two hours so we can monitor your response and ensure your safety. Your treatment plan starts with an induction schedule and then shifts to maintenance at intervals your prescriber sets. After your first month, we reassess how you are responding and adjust your maintenance frequency to match your needs and results.
SPRAVATO carries a boxed warning in its FDA-approved labeling that highlights certain risks. This includes:
Because of these safety requirements, you receive SPRAVATO only through REMS-certified clinics like ours, where we provide the required on-site observation after every dose. We monitor your blood pressure during your visit, and advise you not to drive or operate machinery until the next day after a full night’s sleep.
Short-term effects can include:
SPRAVATO is classified as a Schedule CIII controlled substance.
We review your diagnosis, prior treatments, medical history, and current medications to determine whether SPRAVATO is appropriate for you. According to FDA-approval labeling, SPRAVATO is indicated for adults with TRD, either on its own or alongside an oral antidepressant, and for depressive symptoms in MDD with acute suicidal thoughts or behaviors when paired with an oral antidepressant. In situations involving MDD with acute suicidal thoughts or behaviors, we also prescribe SPRAVATO together with an oral antidepressant. In every case, you receive your doses at our certified clinic with on-site observation and planned follow-up to ensure your safety and support throughout treatment.
When you understand the flow of your SPRAVATO visit, you can plan more easily and feel more comfortable and supported from check-in to discharge.
At check-in, you complete a symptom review and pre-dose assessments, including a blood pressure check. You then receive your supervised intranasal dose in a comfortable setting, and we observe you for at least two hours before discharge.
Following FDA-approved guidelines, we provide clear instructions on rest and activity for the remainder of the day after each SPRAVATO treatment. We also set expectations for your next visit and confirm any transportation needs so you feel prepared every step of the way.
If you want a practical understanding of the FDA-approval of SPRAVATO, you can talk with us about your eligibility, scheduling, and the clinic-based process. We review your history, explain the REMS requirements, and help you decide whether SPRAVATO aligns with your goals and overall care plan. Contact us today at Cedar Park TMS to schedule your consultation.
