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:
- Dissociation
- Dizziness
- Nausea
- Sedation
- Spinning sensation
- Numbness
- Feeling anxious
- Lack of energy
- Increased blood pressure
- Vomiting
- Feeling drunk
- Feeling very happy or excited
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.
Tolerability
SPRAVATO® plus oral antidepressant offers a similar safety profile to previous trials with a minimal risk for weight gain and sexual dysfunction compared to placebo plus oral antidepressant
-
Weight gain observed in patients using SPRAVATO® plus oral antidepressant was similar to patients taking placebo plus oral antidepressant
-
Sexual dysfunction was not seen in more than 2% of patients in the SPRAVATO® clinical trials
4-Year Clinical Study Results
Please review the following information on how the study was designed and the limitations of the study before viewing the 4-year interim analysis data
The following data is from an ongoing, Phase 3, open-label, long-term safety extension study in adults with treatment-resistant depression (TRD).
Limitations:
- The patients and physicians were aware of the treatment being given, and there was no comparator group. Statistical analyses were not done for the efficacy data, which means no conclusions can be drawn from the results
- The results from this study may not represent what every patient may experience. This study only included patients who chose to continue from the previous parent study and the patients in the study did not have two or more significant co-existing diseases (psychiatric or medical, or substance dependence). In addition, the study size got smaller later on in the clinical trial
TRD long-term safety extension study
Study Design
A subgroup analysis was conducted on a group of 1,006 patients who met criteria consistent with the characteristics of the patient population of the initial study (on-label population).
- Patients in this subgroup analysis were between 18-64 years of age and received SPRAVATO® 56 mg or 84 mg twice weekly during induction (IND) phase and flexible dosing during optimization/maintenance (OP/M) phase; all patients should have taken an approved oral antidepressant throughout the study
- The primary purpose of this study was to determine how many patients experienced treatment-emergent adverse events over time while on SPRAVATO®
Safety Results
- 93.5% of patients experienced ≥1 treatment-emergent adverse event
- Three patients (0.7%) in the induction phase (n=436) and 139 patients (14.3%) in the optimization/maintenance (OP/M) phase experienced ≥1 serious adverse event
- Three deaths occurred in the trial (COVID-19; accidental polytrauma, and suicide); none were related to SPRAVATO®
- A total of 60 patients (6.0%) experienced one or more treatment-emergent adverse event related to suicide
SPRAVATO® has been studied in patients with treatment-resistant depression (TRD) for up to four years
- At the four-year mark of the SPRAVATO® ongoing trial, the discontinuation rate due to adverse events was 5.1%
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.
There’s an increased risk of suicidal thoughts and behavior 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 behavior
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