Understanding REMS Certification, Monitoring, and the Patient Experience
If you’re exploring treatment options for depression, you may have come across Spravato®, an FDA-approved nasal spray for adults with treatment-resistant depression (TRD). One of the first things you’ll notice is that Spravato® isn’t something you pick up at the pharmacy and take at home. Instead, it must be administered in a certified clinic under medical supervision.
Why is that?
In this post, we explain what makes Spravato® different from traditional medications, what the REMS program involves, and what you can expect during a treatment session.
To see how this fits into our broader treatment model, visit our Spravato® treatment page.
What Makes Spravato® Different?
Spravato® (esketamine) works on the brain’s glutamate system, rather than serotonin or dopamine like most traditional antidepressants. Because of this unique mechanism, it may relieve symptoms more quickly and in patients who have not responded to other treatments.
Spravato also carries some distinct risks, such as sedation, dissociation, and changes in blood pressure. These effects require close monitoring, which is why it is only available in certified treatment centers like ours in Frisco and Southlake, TX.
What Is the REMS Program and Why Does It Matter?
Spravato® is available only through the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. REMS ensures medications with specific safety concerns are prescribed and administered properly.
To provide Spravato®, treatment centers must be REMS-certified and follow strict safety protocols. These include:
- Administering the medication in a clinical setting only
- Monitoring each patient on-site for at least two hours
- Tracking vitals, alertness, and any side effects
- Reporting treatment data and maintaining compliance
Our team at Compassionate Psychiatric Services is trained and certified to meet all REMS requirements.
Why Supervised Administration Is Essential for Spravato® Treatment
Although at-home treatments are convenient, Spravato® must be administered under clinical supervision for your safety. Side effects like dizziness, disconnection, or a drop in alertness can occur shortly after dosing.
In-office monitoring allows us to:
- Watch for and manage side effects in real time
- Track your response and progress after each session
- Provide reassurance, structure, and support
- Ensure you’re safe before leaving the clinic
What to Expect During a Spravato® Session
Each session typically follows this structure:
- Arrival and check-in: We’ll review your health and prepare your treatment space
- Administration: You self-administer the nasal spray with our guidance
- Observation: You’ll rest for about two hours in a comfortable setting while we monitor your response
- Aftercare: You’ll be released to a caregiver or friend who can drive you home
Most patients begin with twice-weekly sessions for the first four weeks, followed by a maintenance schedule.
How Is Spravato® Different from IV Ketamine?
Spravato® and IV ketamine are both ketamine-based treatments for depression, but they differ in how they are administered and regulated.
- Spravato® is given as a nasal spray in a REMS-certified medical setting, with monitoring for at least two hours.
- IV ketamine is delivered by infusion, often with vital sign monitoring throughout the session. At our clinics, patients receiving IV ketamine are continuously monitored using heart and oxygen monitors.
When Might Spravato® or IV Ketamine Be Recommended?
Both treatments may help individuals with depression that hasn’t improved with standard medications. The best option depends on your health history, insurance coverage, and how you’ve responded to past treatments.
Spravato® may be suggested for those who meet clinical guidelines and prefer a nasal spray option in a highly structured setting. IV ketamine might be considered when flexibility in treatment planning is needed or when rapid symptom relief is a priority.
At Compassionate Psychiatric Services, we’ll work with you to understand your goals and recommend the best approach based on your individual needs.
To compare Spravato® with other advanced treatments like ketamine and TMS, read our post Is Spravato® Right for You? Comparing TMS, Ketamine, and Spravato®.
Looking for a Certified Spravato® Treatment Center Near You?
Compassionate Psychiatric Services offers Spravato® treatment in both Frisco and Southlake, TX. Our team is REMS-certified, highly experienced, and dedicated to supporting patients who haven’t found relief with traditional medications.
We combine advanced treatments like Spravato® with psychiatric care, therapy, and medication management to provide a truly integrated approach to mental health.
Learn More Before Starting
If you’re new to Spravato®, we recommend reading Starting Spravato®? Here’s What to Know About Insurance, Side Effects, and Safety. This guide explains how to prepare, what to expect, and how we help verify your insurance coverage.
You can also learn about How Spravato® Works Differently Than Traditional Antidepressants for a better understanding of how this medication acts on the brain.
Still Have Questions?
If you’re struggling with depression that hasn’t improved with other medications, Spravato® may offer a new path forward. Our team is here to answer your questions, verify your insurance, and walk you through every step of the treatment process.
Call or message us today to schedule a consultation at one of our REMS-certified centers in Frisco or Southlake, TX.
