SPRAVATO® Safety Disclaimer & REMS Information
Important FDA safety information and Risk Evaluation and Mitigation Strategy (REMS) requirements for SPRAVATO® (esketamine).
Important Safety Information: SPRAVATO® (esketamine) CIII Nasal Spray & REMS Program
WARNING: Sedation, Dissociation, Abuse/Misuse, and Suicidal Thoughts and Behaviors
SPRAVATO® (esketamine) nasal spray can cause serious side effects, which is why it is only available through a restricted distribution program called the SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy) Program at certified healthcare settings like Attuned Psychiatry.
1. Sedation and Dissociation
- SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, space, and time (dissociation).
- Because of these risks, a healthcare provider at Attuned Psychiatry will monitor you for at least 2 hours after you self-administer SPRAVATO® nasal spray before determining when you are clinically stable to leave.
2. Respiratory Depression
- Slowed or decreased breathing (respiratory depression) can occur after SPRAVATO® administration. Your oxygen saturation and vital signs are monitored during your 2-hour post-dose observation period.
3. Risk of Abuse and Misuse
- SPRAVATO® is a Schedule III controlled substance (CIII) and carries a risk for abuse and physical or psychological dependence. It is never dispensed for home use.
4. Increased Risk of Suicidal Thoughts and Behaviors in Young Adults
- Antidepressant medicines may increase suicidal thoughts and behaviors in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not approved for use in pediatric patients.
5. Driving & Machinery Restrictions
Do not drive, operate machinery, or do anything where you need to be completely alert after your SPRAVATO® treatment session until the next day following a restful sleep. You must plan for a trusted caregiver, family member, friend, or rideshare service to take you home after each session.
6. Contraindications
Do not take SPRAVATO® if you have aneurysmal vascular disease (including in the brain, chest, abdominal aorta, arms, or legs), an arteriovenous malformation, a history of bleeding in the brain (intracerebral hemorrhage), or a known allergy to esketamine, ketamine, or any ingredient in SPRAVATO®.