What Is the Spravato REMS Program? A Patient Guide

Key takeaways

• The Spravato REMS program is a FDA program to make sure the drug is only administered at certified Spravato treatment centers that follow patient safety guidelines.
• REMS guidelines affect patients who take Spravato and certified clinics. Patients are responsible for staying at the clinic for a two hour monitoring period after administration and not driving for the rest of the day.
• The program also has an enrollment process, which requires patients to sign a form acknowledging the REMS guidelines.
• Working with an experienced REMS-certified clinic is often the best way to make the process as straightforward as possible.

Starting a new treatment can be overwhelming. There’s tons of paperwork to fill out, questions on what insurance will cover, matierals  or instructions to review — and this is alongside the anxiety of trying a new medication. If you’re starting Spravato, you may have encountered the term Spravato REMS during the intake process and wondered what it was.

REMS is a safety program with specific requirements on how to administer certain medications, including Spravato. Most of the program’s regulations involve the clinic, not the patient, but there are a few to be aware of before considering Spravato as a potential treatment. Continue reading to learn how this program relates to this medication specifically, as well as how it impacts your enrollment process and treatment days. 

What is the Spravato REMS program?

REMS stands for Risk Evaluation and Mitigation Strategy.  It’s a drug-safety program set up by the FDA to make sure certified healthcare centers take necessary measures for patient safety during administration. Spravato is part of the FDA REMS program.

Drugs that have REMS requirements are administered differently from a typical prescription or over-the-counter medication. For example, I take a daily allergy medicine, which I pick up at the pharmacy and swallow around the same time each day. On the other hand, Spravato treatment requires more consideration for safe administration than my allergy medication, which is why it is part of the REMS program. 

“The REMS system exists for any medication, whether it's a controlled substance or not, that has specific responsibilities built in for the provider, for the pharmacy, and sometimes also for the patient,” says MaryEllen Eller, MD, a board-certified psychiatrist and regional medical director at Radial. “It's purely to hold the entire system accountable for following the regulatory guidelines and making sure that the molecule is delivered in a responsible way.”

Why does Spravato have a REMS?

The FDA label for Spravato states that it is placed in a REMS program because of the medication’s potential for adverse events related to specific Spravato side effects, mainly dissociation and sedation, but also respiratory depression (decreased breathing) and blood pressure spikes.The label also states the program limits the risk of Spravato misuse or abuse. 

Inclusion in the REMS program doesn’t mean adverse events are common; a 2026 paper in BJPsych Open describes the majority of Spravato side effects as “mild and transient.” Still, serious adverse effects are possible with Spravato, and the REMS is in place to reduce the likelihood of such effects,  and make sure that a patient is in a safe environment with access to medical providers should they happen. 

What does the Spravato REMS require?

We’ve covered what the REMS program is and why it applies to Spravato, but what exactly are the Spravato REMS requirements? Per a 2026 article in Clinical and Translational Science, the main requirements are:

• Administration in a certified setting: Spravato can only be administered in a REMS certified clinic, like Radial. A patient cannot take the medication at home or anywhere else.
• Patient enrollment: Before treatment, a patient must fill out a Spravato patient enrollment form. Dr. Eller states that this form is reviewed and signed in office. With their signature, the patient acknowledges that they can’t bring the medication home, they must remain at the clinic for administration and the subsequent monitoring period, and they can’t drive after. They also agree to have patient information documented on the FDA REMS database.
• No driving after: A patient must agree to follow specific guidelines, such as not driving home from the clinic after treatment or for the rest of the day. That means it’s the patient’s responsibility to coordinate travel home after (and probably before, unless you want to pick up your car at a later date).
• Prescriber onsite: A provider who can prescribe Spravato must be at the clinic for the majority of the treatment.
• Spravato patient monitoring: A patient must be monitored for at least two hours in the clinic after they self-administer Spravato. 
• Specific assessment process: To make sure the patient has a safe experience, the care team will monitor them for at least  two hours after Spravato administration. There are also specific guidelines on how to assess key vitals, like blood pressure. Spravato may cause a temporary elevation in blood pressure that could be dangerous for some patients. As such, the care team should check the patient’s blood pressure before they take Spravato and periodically during the two hour monitoring period, says Dr. Eller. The care team will also perform a clinical assessment before letting the patient leave.
• Reporting: The clinic must document relevant information on each Spravato session and upload it to the FDA-run REMS database.

What patient enrollment involves

The clinic must enroll the patient in the REMS program before starting treatment. A majority of the enrollment to-dos fall on the clinic’s shoulders, says Dr. Eller, though a patient will need to sign an enrollment form. The provider then submits the signed form to REMS along with other enrollment paperwork.

Before signing, the care team will review any relevant information, such as:

• Current medical or psychiatric conditions, contraindications, or medications
• A small overview of the REMS program
• The potential risks of Spravato
• What the monitoring process looks like at their specific clinic
• Safety precautions a patient must take, such as not driving after
• Advice on what to expect on treatment day
• Answers to any other questions a patient has

What REMS means on treatment days

On treatment days, REMS mainly impacts what happens after Spravato administration. That starts with the mandatory two-hour monitoring period. When I first pictured the two-hour monitoring period, an image of awkwardly sitting across from the prescribing provider making uncomfortable eye contact came to mind. However, this is not what the process looks like. 

At Radial, Dr. Eller says they have a system in place where the care team can directly monitor a patient after they administer the medication without having to be in the same room the entire time. This system allows them to protect the privacy of the patient’s experience but makes sure a member of the care team is available immediately if the patient needs a drink, to get up, is struggling with a side effect, or needs any other type of assistance. 

After that monitoring period ends, there’s one more REMS requirement to remember: You can’t drive home (or for the rest of the day). If you live somewhere like New York City, you might be able to take the subway home. If the public transportation around you is limited, you can ask a loved one for a ride home, call a taxi, or use a rideshare app. 

What the Spravato REMS covers — and what it doesn’t

The Spravato REMS program is run by the FDA to ensure only certified clinics administer the medication, following specific guidelines mentioned above. There are also a few other steps  clinics must take that don’t involve the patient.

The healthcare clinic, for example, must order the medication from a Spravato REMS certified pharmacy, and the patient cannot pick up the prescription or take Spravato at home. 

The clinic must also document and report information on the monitoring period, any side effects, and the patient’s experience. For some patients, having that information in a federal database can be a concern, says Dr. Eller, but there is no way around mandatory reporting. 

What REMS certification doesn’t tell you is the quality of the clinic. While REMS establishes the minimum safeguards for administration, monitoring, and outpatient enrollment, it can’t tell you if you’ll feel comfortable at the clinic, how the care team responds to side effects, and more. 

To find out if a clinic works for you, you may need to do some detective work. Ask questions, assess your comfort level when visiting the clinic, and research the practice’s approach. Radial’s Spravato treatment is a good example of what a quality clinic might look like. 

How to plan around REMS requirements

While clinics take care of most REMS requirements, there are a few ways the program impacts patients too. Here are some things to consider before starting this treatment:

• Scheduling: Since the clinic monitors you for two hours, this isn’t a treatment to fit into a busy day. Look at your calendar and determine when you have time for the treatment, consider how often a provider recommends you take Spravato.
• Rides: You can’t drive after Spravato, so you may also want to recruit a loved one as an unofficial chauffeur or look into public transport options near your clinic. 
• Emotional support: The treatment can be emotionally intensive, with a 2024 FDA database review published in Frontiers in Pharmacology reporting that 70% of Spravato’s side effects are psychiatric. As such, some people may appreciate having a loved one nearby for emotional support as well as a ride home. Others may make time for a self-care activity or to journal and process their treatment after.
• Cost and insurance: REMS enrollment is a safety program run by the FDA. It is separate from an insurer's prior-authorization and coverage processes, though a REMS-certified clinic should be able to help you determine whether your insurance covers Spravato.
• Switching clinics or moving: When a patient enrolls in REMS, they are associated with a specific clinic. If they move, there’s a process to change the administration site in the REMS database. Dr. Eller says this process is something that happens behind the scenes with no work required on a patient’s part, but it’s important to mention that you’re already enrolled in REMS if switching providers. 

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The bottom line

The REMS program is an effective way to make sure clinics administering Spravato do so in a way that considers patient safety. As a patient, the program typically involves filling out one enrollment form and following guidelines, such as staying at the clinic for the two hour monitoring period and not driving for the rest of the day. To make REMS easy, seek treatment at an experienced, quality REMS-certified clinic, such as Radial. 

Frequently asked questions (FAQs)

Can I receive Spravato at home?

You cannot receive Spravato at home. Per the FDA drug label, someone must receive Spravato in a REMS-certified clinic. Afterwards, they must stay in the clinic for a two hour monitoring period. This monitoring period allows the care team to watch for any side effects and to assess if it’s safe for the patient to leave the clinic.

Why do I have to stay for at least two hours after Spravato?

Spravato has a two-hour monitoring period so the care team can monitor for any side effects or adverse reactions. Spravato may cause side effects like sedation or disassociation, which are strongest right after treatment, which is why the monitoring period exists.

What happens if I switch Spravato clinics?

If you switch Spravato clinics, it’s important to tell the new clinic that you’re already registered in the REMS program. A patient can only be registered at one REMS-certified healthcare setting, so the new clinic would have to contact the REMS program and ask to switch you over to their clinic.