Spravato, or esketamine nasal spray, is different from many medications used to manage depression because it must be administered under specific safety conditions. The U.S. Food and Drug Administration requires Spravato to be available through a Risk Evaluation and Mitigation Strategy, commonly called REMS. This program is designed to manage specific risks associated with the medication and ensure it is used in an appropriate healthcare setting.
REMS stands for Risk Evaluation and Mitigation Strategy. The FDA uses REMS programs for certain medications when additional safety measures are needed to ensure that their benefits outweigh their risks. The Spravato REMS specifically addresses concerns associated with sedation, dissociation, respiratory depression, and the potential for abuse or misuse.
Because of these risks, Spravato cannot simply be dispensed for patients to take home. It must be administered in a healthcare setting that is certified through the Spravato REMS program.
This additional structure helps ensure that patients receive the medication with appropriate supervision and monitoring.
Spravato can temporarily affect alertness, judgment, coordination, and perception. Some patients may experience sedation or dissociation after administration. Blood pressure can also increase temporarily, and respiratory depression is another potential concern.
The medication also has potential for abuse and misuse. Because of these considerations, the FDA requires specific safeguards around how Spravato is dispensed and administered.
The REMS program does not mean that every patient will experience a serious reaction. Instead, it creates a controlled process that allows potential problems to be recognized and addressed promptly.
A healthcare setting must meet specific requirements before it can provide Spravato through the REMS program. The setting must be certified and have appropriate procedures in place for treatment and patient monitoring.
Patients receive Spravato under the direct supervision of a healthcare provider. The medication is not dispensed directly to patients for use outside the certified healthcare setting.
At Scottsdale TMS & Spravato, Spravato treatment takes place under professional supervision. The treatment process includes administration of the nasal spray followed by an observation period while the clinical team monitors the patient’s response.
Monitoring is one of the most important components of the Spravato REMS. Healthcare providers must observe patients for at least two hours following administration for resolution of sedation and dissociation and for changes in vital signs.
Blood pressure is also monitored because Spravato can temporarily raise it. The healthcare team watches for changes in alertness, perception, breathing, and overall condition during recovery.
Patients should remain at the treatment center throughout the required observation period. The provider determines when the patient is clinically stable enough to leave.
Patients have responsibilities as part of safe Spravato treatment. Before receiving the medication, a healthcare provider explains the treatment, monitoring requirements, and important safety risks.
Patients must receive Spravato under direct supervision and remain at the healthcare setting for the required observation period. They also need to arrange transportation home because the medication can temporarily affect alertness, attention, and coordination.
Following these requirements helps keep the treatment process organized and reduces risks associated with impaired judgment or coordination after administration.
A REMS requirement should not automatically be interpreted as meaning a medication is unsafe for appropriate patients. Rather, it indicates that the FDA has determined additional safeguards are necessary because of specific risks.
The purpose of a REMS is to support safe use by establishing requirements for healthcare settings, providers, pharmacies, and, when applicable, patients.
For Spravato, these safeguards are especially relevant because effects such as sedation and dissociation can occur shortly after administration. Having trained professionals present provides an opportunity to monitor patients while these effects occur.
Understanding the REMS requirements can make the treatment process less confusing. Instead of wondering why Spravato cannot be taken at home or why an observation period is necessary, patients can recognize that these steps are part of the medication’s established safety framework.
Dr. Michael Vines and Our Team at Scottsdale TMS & Spravato can explain the REMS requirements, what happens during treatment, and what patients should expect before, during, and after each session.
The treatment team can also discuss your medical history, current medications, and individual circumstances to determine whether Spravato is an appropriate option.
The Spravato REMS is an FDA-required safety program designed to manage important risks associated with esketamine nasal spray, including sedation, dissociation, respiratory depression, and abuse or misuse.
The program requires Spravato to be administered in a certified healthcare setting under direct supervision, with patients monitored for at least two hours after treatment. These safeguards help create a controlled environment where changes in a patient’s condition can be identified and addressed. Scottsdale TMS & Spravato follows a supervised treatment approach that allows eligible patients to receive esketamine while these safety requirements are maintained.
Dr. Vines has practiced psychiatry in Arizona for for over 25 years and has experience working with diverse populations that include children, adolescents, adults, geriatrics, SMI patients, and the chemically dependent.
September 1, 2026
