Limitations of Use:
SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in children.
In clinical studies of adults with MDD with suicidal thoughts or actions, those who took SPRAVATO® and an oral antidepressant experienced a greater reduction of depressive symptoms at 24 hours compared to those who received a placebo plus an oral antidepressant.*
*Based on an overall score on a standardized rating scale.
Further reductions were seen consistently through four weeks (25 days) of treatment, so it is important to follow the treatment plan that you and your healthcare provider have made. Not all patients will respond to SPRAVATO®.
Serious side effects of SPRAVATO® include feeling sleepy (sedation or loss of consciousness) feeling disconnected from yourself, your thoughts, feelings and things around you (dissociation); breathing problems (respiratory depression and respiratory arrest); abuse and misuse; increased risk of suicidal thoughts and behavior; increased blood pressure; problems with thinking clearly and bladder problems.
The most common side effects that can occur during and after taking SPRAVATO® include:
Less than 7% of patients stopped SPRAVATO® treatment due to side effects in short- and long-term clinical studies.
These are not all the possible side effects of SPRAVATO®. Please see the SPRAVATO® Medication Guide for the complete safety information.
Because of the risks for sedation or loss of consciousness, dissociation, respiratory depression and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
There’s an increased risk of suicidal thoughts and actions with SPRAVATO®
Call your healthcare provider right away if you have new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or actions.
Help is available 24/7. If you’re struggling with suicidal thoughts, call 988 Suicide & Crisis Lifeline
Help is available 24/7. If you’re struggling with suicidal thoughts, call 988 Suicide & Crisis Lifeline
After you and your healthcare provider have decided SPRAVATO® is right for you and you understand the benefits and risks, you can start planning for treatment.
The SPRAVATO® Patient Brochure is a helpful resource to learn about SPRAVATO® and depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions (MDSI).
