Risk Evaluation and Mitigation Strategy (REMS)

The goal of the XYREM REMS Program is to mitigate the risk 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

XYREM REMS Program Overview

  • All prescribers must enroll in the XYREM REMS Program and comply with requirements for prescribing XYREM
  • All patients must be enrolled in the XYREM REMS Program to receive XYREM
  • All patients are required to be counseled on the serious risks and safe use of XYREM
  • XYREM will be dispensed only by the central pharmacy that is specially certified

XYREM is approved for:

  • Treatment of cataplexy in patients with narcolepsy
  • Treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy

If you require any additional assistance or information, please call the XYREM REMS Program at 1-866-XYREM88® (1-866-997-3688)