REMS-Certified SPRAVATO® Treatment Center in Baltimore

FDA-Regulated Esketamine Therapy with Full Medical Oversight

Vita Nova Ketamine & Wellness Clinic is a REMS-certified provider of SPRAVATO® (esketamine) nasal spray. We follow all FDA safety protocols, including on-site monitoring, dose tracking, and licensed administration. All treatments are provided in a private, medically supervised setting.

✅ Vita Nova Ketamine & Wellness Clinic is officially certified in the SPRAVATO® REMS program.
Certification can be provided upon request for regulatory review or patient verification.

🔗 Learn more about the official SPRAVATO® REMS Program →

🧪 SPRAVATO® REMS Compliance at Vita Nova Ketamine & Wellness Clinic

Safe, FDA-Regulated Care in a REMS-Certified Clinic

At Vita Nova Ketamine & Wellness Clinic in Baltimore, we are proud to be a REMS-certified SPRAVATO® treatment center, authorized by the U.S. Food and Drug Administration (FDA) to safely administer SPRAVATO® (esketamine nasal spray) for patients who meet eligibility criteria.

The REMS (Risk Evaluation and Mitigation Strategy) program ensures that all SPRAVATO® treatments are provided in a strictly controlled and medically supervised environment to protect your safety and well-being.

✅ What Is the SPRAVATO® REMS Program?

SPRAVATO® is a Schedule III controlled substance and a form of esketamine that carries risks of sedation, dissociation, and misuse. That’s why the FDA requires any clinic that administers SPRAVATO® to comply with the SPRAVATO® REMS program.

This program includes:

Certified treatment center registration
Mandatory patient observation for at least 2 hours
Ongoing staff training and clinical oversight
Adverse event reporting
Strict documentation and tracking through the REMS portal

👩‍⚕️ Who Administers SPRAVATO® at Vita Nova?

SPRAVATO® is administered by our licensed medical team, including:

• A board-certified physician

• A certified registered nurse anesthetist (CRNA)

• A family nurse practitioner (FNP)

• A psychiatric-mental health nurse practitioner (PMHNP), licensed in Maryland

All providers are trained and credentialed in accordance with the SPRAVATO® REMS program. Every session is conducted in a private treatment room with full medical monitoring to ensure patient safety.

🛡️ How We Ensure Your Safety

Every SPRAVATO® session at Vita Nova follows a structured, REMS-compliant care process:
- ✔️ Pre-treatment screening and vital signs check
- ✔️ Supervised self-administration of the SPRAVATO® nasal spray
- ✔️ Continuous monitoring for at least 2 hours
- ✔️ Side effect documentation (e.g., dissociation, dizziness, sedation)
- ✔️ Post-session vital checks and clinical sign-off before discharge
⚠️ Patients cannot drive after treatment. You must arrange a ride home from a trusted adult.

📊 How We Track Progress and Treatment Response

Our team uses the REMS portal and secure internal records to:
- Track dosing, treatment sessions, and vital signs
- Log any adverse events or side effects
- Monitor your clinical response over time
- Share updates with referring providers (if applicable)
- Reassess eligibility before continuing treatment
Your progress is reviewed regularly to ensure that SPRAVATO® remains safe and effective for your unique needs.

✅ Conditions Treated at Our REMS-Certified Clinic

We offer SPRAVATO® treatment for both FDA-approved and off-label indications:
FDA-Approved Indications:
- Treatment-Resistant Depression (TRD)
- Major Depressive Disorder with Suicidal Thoughts or Behavior
Off-Label Conditions (evaluated case by case):
- Post-Traumatic Stress Disorder (PTSD)
- Obsessive-Compulsive Disorder (OCD)
- Bipolar Depression
- Postpartum Depression
- Emotional Numbness or Disconnection
- Anxiety with Co-Occurring Depression

❓Frequently Asked Questions – SPRAVATO® REMS

What is a REMS-certified clinic?

It means our clinic is authorized by the FDA to administer SPRAVATO® under strict safety guidelines, including real-time monitoring, recordkeeping, and staff credentialing.

Will I be monitored during treatment?

Yes. You’ll remain under direct supervision in a private treatment room for at least 2 hours following each dose.

Can I drive after a SPRAVATO® session?

No. You must have a responsible adult pick you up after treatment. Rideshare apps like Uber/Lyft are not permitted unless accompanied by a trusted person.

Who gives the treatment?

SPRAVATO® is administered by our trained team: a physician, a CRNA, a family nurse practitioner (FNP), and a psychiatric nurse practitioner (PMHNP), all REMS-certified and experienced in esketamine care.

What if I’m using SPRAVATO® for a condition like PTSD or OCD?

These are off-label uses. You’ll go through a clinical evaluation and consent process to ensure it’s appropriate for your situation. All care is delivered with full medical oversight.

Where can I learn about side effects?

Visit our Side Effects & Risk Disclosures page → for a complete list of potential effects, safety steps, and emergency reporting instructions.

⚖️ Off-Label Use Disclaimer

SPRAVATO® is FDA-approved only for treatment-resistant depression (TRD) and major depressive disorder (MDD) with suicidal thoughts or behavior.
Its use for other mental health conditions—such as PTSD, OCD, bipolar depression, postpartum depression, or emotional numbness—is considered off-label and is offered only after clinical evaluation and informed consent.
All off-label treatments are administered under the guidance of licensed medical professionals in accordance with REMS requirements.