Spravato is a prescription nasal spray used for certain adults with treatment-resistant depression and, with an oral antidepressant, for depressive symptoms associated with major depressive disorder with acute suicidal ideation or behavior. Because esketamine can cause sedation, dissociation, respiratory depression, and has potential for abuse or misuse, the FDA requires it to be provided through a restricted safety program called the Spravato REMS.
REMS stands for Risk Evaluation and Mitigation Strategy. The FDA uses REMS programs when additional safety measures are needed beyond standard prescribing information. For Spravato, the program is designed to reduce risks associated with sedation, dissociation, respiratory depression, and abuse or misuse.
The REMS means Spravato cannot simply be prescribed for a patient to take home. Treatment must occur under specific conditions in a certified healthcare setting.
After administration, some patients may experience sedation, dissociation, dizziness, changes in attention or judgment, or other temporary effects. Respiratory depression has also been reported after treatment.
Because of these risks, patients must be monitored by a healthcare provider for at least two hours after each dose. Respiratory status, including pulse oximetry, must be monitored during this period, followed by an assessment to determine whether the patient is clinically stable enough to leave.
The two-hour period is a minimum. Additional monitoring may be appropriate depending on the patient’s condition.
Spravato is administered under the direct supervision of a healthcare provider in a certified healthcare setting. The medication is not dispensed for patients to administer independently at home.
Before treatment, providers review relevant health information and discuss potential risks and monitoring requirements. Patients are enrolled in the Spravato REMS before administration, according to the program requirements. The healthcare setting also has procedures in place to support appropriate dispensing, administration, monitoring, and documentation.
Blood pressure is also assessed because Spravato can temporarily increase blood pressure.
Transportation planning is an important part of Spravato treatment. Patients should arrange transportation home after their appointment because the medication can temporarily affect alertness, judgment, and coordination.
The FDA prescribing information states that patients should not drive or operate machinery until the following day after a restful sleep.
Planning transportation before each appointment can make the treatment process easier and help patients focus on their recovery after the monitoring period.
Our Team follows a supervised approach to Spravato treatment, including observation during the required post-treatment period. Patients are encouraged to communicate any unusual symptoms, concerns, or changes they experience during a session.
Dr. Michael Vines and the clinical team can review individual circumstances and help patients understand what to expect from treatment, monitoring, and follow-up care.
The Spravato REMS program provides specific safety requirements because esketamine can cause temporary sedation, dissociation, respiratory effects, and other risks. Certified healthcare settings, supervised administration, patient enrollment, and post-treatment monitoring are key parts of the program.
Scottsdale TMS & Spravato provides supervised Spravato care within a structured treatment environment. Understanding the REMS requirements can help patients know why treatment must take place in a monitored setting and why transportation and observation are important parts of every session.
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 13, 2026
