U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. REMS

Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Xywav and Xyrem (calcium, magnesium, potassium, and sodium oxybates)
NDA #021196 NDA #212690
REMS last update: 03/04/2024



What is the purpose of the REMS?

The goal of the XYWAV and XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM by:

  1. Informing prescribers, pharmacists, and patients of:
    1. The risk of significant CNS and respiratory depression associated with XYWAV and XYREM.
    2. The contraindication of use of XYWAV and XYREM with sedative hypnotics and alcohol.
    3. The potential for abuse, misuse, and overdose associated with XYWAV and XYREM.
    4. The safe use, handling, and storage of XYWAV and XYREM.
  1. Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
    1. Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
    2. Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM.
    3. Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

View additional drug-specific postmarket safety information from the FDA

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
03/04/2024 Revised to make editorial changes.
01/16/2024 Modified to add electronic prescribing functionality to the REMS website to allow prescribers to register for the Drug Enforcement Administration (DEA) Electronic Prescribing for Controlled Substances (EPCS) and submit Xywav or Xyrem Prescription Forms electronically through the REMS website directly to the Certified Pharmacy.
02/09/2022 Modified to make changes to the XYWAV and XYREM Prescription Forms to decrease prescriber confusion when documenting the indication for use and signing the form.
12/09/2021 Modified to make changes to the dosing table structure on the Xywav Prescription Form to prevent confusion when the prescriber fills out the form.
08/12/2021 Modified to:
  1. Make changes to the REMS materials to align with the new indication of Idiopathic Hypersomnia for Xywav
  2. Make changes to the REMS assessment timetable
  3. Change the reporting interval for the Knowledge, Attitude, and Behavior Surveys from annually to every other year
  4. Make changes to the Patient Counseling Checklist to capture additional information regarding concomitant medication and alcohol use
02/11/2021 Modified to make revisions to the most common side effects in pediatric patients listed in the Patient Counseling Checklist, Prescriber Brochure, the Xyrem and Xywav Brochures for Pediatric Patients and their Caregivers, and the REMS Supporting Document to conform with a recently approved prior approval supplement. Modified to revise the REMS document, REMS supporting document, and appended REMS materials to allow for the addition of an authorized generic for Xyrem.
07/21/2020 Modified to make changes to the REMS document, add an additional NDA number to include Xywav (NDA 212690),change the name of the REMS to the ‘Xywav and Xyrem REMS’, update the REMS Document to include Xywav.In addition, this REMS modification updates the format and content of the REMS Document consistent with the October 2017 Draft Guidance. Changes to the REMS materials to add an additional NDA to include Xywav (NDA 212690),addition of the following new REMS materials: Xywav REMS Prescription Form, Xywav REMS Patient Quick Start Guide, and Xywav REMS Brochure for Pediatric Patients and Their Caregivers.
10/26/2018 Modified to update the REMS document and materials to align with labeling changes related to the new pediatric indication.
07/15/2015 Modified to change the name of the REMS from the “Xyrem Success Program” to “Xyrem REMS Program” in the Medication Guide.
02/27/2015 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

Back to Top