XYWAV and XYREM REMS

The XYWAV and XYREM REMS (Risk Evaluation and Mitigation Strategy) is a safety program that manages the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM. The XYWAV and XYREM REMS is required by the Food and Drug Administration (FDA) to ensure the potential benefits of XYWAV and XYREM outweigh the risks.

What are XYWAV and XYREM?


XYWAV is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. It is also indicated for the treatment of idiopathic hypersomnia (IH) in adults.


XYREM is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.