Inpatient Healthcare Settings

SPRAVATO® REMS Inpatient Healthcare Setting Enrollment

Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®.

SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, due to risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. SPRAVATO® is intended for use only in a certified Healthcare Setting.

Inpatient Healthcare Settings are NOT required to enroll patients or submit Patient Monitoring Forms to the SPRAVATO® REMS.

As an Inpatient Healthcare Setting (with inpatient units, emergency department, etc.), your Inpatient Pharmacy, operating under the same Drug Enforcement Administration (DEA) license and physical location, will be considered certified once the Inpatient Healthcare Setting Enrollment form is completed/submitted. A separate pharmacy enrollment is not required.

Inpatient Healthcare Settings are required to report all suspected adverse events to the SPRAVATO® REMS at 1-855-382-6022.

How does my Inpatient Healthcare Setting become certified in the SPRAVATO® REMS?

Step 1: Designate an Authorized Representative to oversee implementation and compliance with the REMS requirements.

Step 2: Review the following materials:

  • SPRAVATO® Prescribing Information
  • SPRAVATO® REMS Program Overview

Step 3: Complete and submit the SPRAVATO® REMS Inpatient Healthcare Setting Enrollment Form to the REMS.