MDSI: Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.
SPRAVATO®: proven effective for depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions (MDSI)
Depressive symptoms may include: Depressed mood or feelings of sadness; disrupted sleep; lack of interest or inability to feel pleasure (anhedonia); feelings of guilt or hopelessness; lack of energy; difficulty concentrating; changes in appetite or weight; slowed thoughts or movements (psychomotor retardation); restlessness and/or purposeless movements (psychomotor agitation); suicidal thoughts or actions.
Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.
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.
You may benefit from adding SPRAVATO® to your existing oral antidepressant.
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:
If SPRAVATO® side effects occur, they usually happen right after taking SPRAVATO® and go away the same day
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.
To help ensure your safety, SPRAVATO® has a program called SPRAVATO® REMS (Risk Evaluation and Mitigation Strategy), which requires close monitoring of safety
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.