Approved Risk Evaluation and Mitigation Strategies (REMS)

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

View the Xyrem Prescribing Information and Medication Guide at DailyMed.
View Xyrem's Regulatory Information at Drugs@FDA

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.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
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.
During treatment; before each prescription
  • Complete the Prescription Form and submit to the REMS Program.
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.
  • Receive counseling from the prescriber on serious risks, and safe use, handling, and storage.
  • Review the Patient Quick Start Guide.

Pharmacies that dispense Xyrem must

To become certified to dispense
  • Train all relevant staff involved in dispensing using the Pharmacy Training Program.
Before dispensing
  • Complete the Patient Counseling Checklist and submit to the REMS Program.
  • 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.

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:


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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