SPRAVATO® Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SPRAVATO®? SPRAVATO® can cause serious side effects, including: sedation and dissociation; respiratory depression; abuse and misuse; and suicidal thoughts and behaviors.

Sedation and dissociation

SPRAVATO® can cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation). Because of the risk of sedation and dissociation, you must be monitored by a healthcare provider for at least 2 hours after receiving your dose of SPRAVATO®.

Respiratory depression

Breathing may slow down or stop (respiratory depression), which has been reported with SPRAVATO®, especially when used with other medicines that can cause sedation.

Abuse and misuse

SPRAVATO® is a federally controlled substance (CIII) because it can be abused or lead to dependence. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Suicidal thoughts and behaviors

Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, and call your healthcare provider right away if you notice new or sudden changes.

REMS and monitoring

Because of the risks of sedation, dissociation, abuse and misuse, and suicidal thoughts and behaviors, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). SPRAVATO® must be administered under the direct observation of a healthcare provider in a certified healthcare setting, and you must be monitored by a healthcare provider for at least 2 hours after receiving your dose. You will not be able to take SPRAVATO® home; it must be taken in a certified healthcare setting. Do not drive, operate machinery, or do anything where you need to be completely alert until the next day after a restful sleep.

Full prescribing information

Read the complete Important Safety Information, Medication Guide, and full Prescribing Information, including the Boxed Warning, at https://www.spravato.com.