Approved Risk Evaluation and Mitigation Strategies (REMS)

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Xyrem (Sodium oxybate)
NDA #021196
REMS last update: 07/15/2015



What is the purpose of the REMS?

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

  1. Informing prescribers, pharmacists, and patients of:
    1. The risk of significant CNS and respiratory depression associated with XYREM.
    2. The contraindication of use of XYREM with sedative hypnotics and alcohol.
    3. The potential for abuse, misuse, and overdose associated with XYREM.
    4. The safe use, handling, and storage of XYREM.
  2. Ensuring that pharmacy controls exist prior to filling prescriptions for 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 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

Healthcare Providers who prescribe Xyrem must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the Prescriber Brochure.
    | Prescriber Brochure |
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
    | Prescriber Enrollment Form |
Before treatment initiation
  • Determine that Xyrem is medically appropriate for the patient.
  • Assess the patient for a history of alcohol or substance abuse; history of sleep-related breathing disorders; history of compromised respiratory function; concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; and history of depression or suicidality.
  • Counsel the patient on the serious risks and safe use, handling, and storage.
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
    | Patient Enrollment Form |
During treatment; before each prescription
  • Complete the Prescription Form and submit to the REMS Program.
    | Prescription Form |
During treatment; within the first 3 months and recommended every 3 months thereafter
  • Assess the patient for concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; serious adverse events; and signs of abuse and misuse, including an increase in dose or frequency of dosing, reports of lost, stolen, or spilled medication, and drug-seeking behavior.
At all times
  • Report all potential serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, death, and any cases of abuse, misuse, or diversion to the REMS Program.

Patients who are prescribed Xyrem

Before the first prescription
  • Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient Enrollment Form |
  • Receive counseling from the prescriber on serious risks, and safe use, handling, and storage.
  • Review the Patient Quick Start Guide.
    | Patient Quick Start Guide |

Pharmacies that dispense Xyrem must

To become certified to dispense
Before dispensing
  • Complete the Patient Counseling Checklist and submit to the REMS Program.
    | Patient Counseling Checklist |
  • Verify the prescriber and patient are enrolled and that the patient has no other active Xyrem prescription using the REMS Program Central Database.
  • Verify prescription information on the prescription form.
  • Review the patient information using the REMS Program Central Database.
Before shipping
  • Verify and confirm the patient’s shipping address with the patient or their patient-authorized adult representative and that they will be available to receive the shipment.
  • Ship the product directly to the patient or their patient-authorized adult designee using an overnight service.
  • Provide the patient with the Medication Guide with each shipment.
  • For the first shipment: provide the patient with the Patient Quick Start Guide.
  • For the first shipment: dispense no more than a one-month supply.
  • For shipments after the first: dispense no more than a three-month supply.
After receipt of the shipment
  • Enter the shipment and receipt dates to the REMS Program Central Database.
At all times
  • Report all potential adverse events reported by all sources, including any CNS depression, respiratory depression, loss of consciousness, coma, and death and any cases of suspected abuse, misuse, or diversion to Jazz Pharmaceuticals.
  • Report all instances of patient or prescriber behavior that gives rise to a reasonable suspicion of abuse, misuse, or diversion to Jazz Pharmaceuticals.
  • For early refills including lost, stolen, destroyed, or spilled drugs: complete and submit the Risk Management Form to the REMS Program.
  • Provide 24-7 toll-free access to a pharmacist in the REMS Program.

View additional drug-specific postmarket safety information from the FDA

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Xyrem REMS, see the DailyMed link(s).
Material Name Material Name Link
Certified Pharmacy Training Program (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Certified_Pharmacy_Training_Program.pdf
Patient Counseling Checklist (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Counseling_Checklist.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Enrollment_Form.pdf
Patient Quick Start Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Patient_Quick_Start_Guide.pdf
Prescriber Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescriber_Brochure.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescriber_Enrollment_Form.pdf
Prescription Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_Prescription_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_REMS_full.pdf
Risk Management Report Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/XYREM_2015-02-27_RISK MANAGEMENT REPORT FORM .pdf
Website (www.xyremrems.com) screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xyrem_07-15-2015_website_(www.XYREMREMS.com).pdf

What updates have been made to the REMS?

Date Summary of change
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.

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