XYREM® (sodium oxybate) oral solution, 0.5 g/mL may only be dispensed to patients enrolled in the XYREM REMS Program. XYREM is indicated for the treatment of cataplexy in narcolepsy and/or excessive daytime sleepiness (EDS) in narcolepsy.
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and MISUSE AND ABUSE
XYREM is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in XYREM-treated patients. Almost all of the patients who received XYREM during clinical trials in narcolepsy were receiving CNS stimulants.
XYREM is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression, abuse, and misuse, XYREM is available only through a restricted distribution program called the XYREM REMS Program, using the central pharmacy that is specially certified. Prescribers and patients must enroll in the program. For further information go to www.XYREMREMS.com or call 1-866-XYREM88® (1-866-997-3688).
XYREM is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency.
In three controlled clinical trials, the most common adverse reactions (incidence ≥5% and twice the rate of placebo) in XYREM-treated patients were nausea (20%), dizziness (15%), vomiting (11%), somnolence (8%), enuresis (7%), and tremor (5%).
Reference: 1. XYREM® (sodium oxybate) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals; 2015.