FDA approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Cataplexy and its mimics: clinical recognition and management. National Institute of Neurological Disorders and Stroke. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program. Food and Drug Administration ( FDA) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older. Xywav label.Īmerican Academy of Sleep Medicine. Xyrem oral solution, CIII, is the only product approved by the U.S.
These types of reactions to Xywav are rare.įood and Drug Administration. Some people might experience a serious reaction called anaphylaxis that could lead to a tightening of the airways and throat, trouble breathing, reduced blood pressure, seizures, and other serious symptoms.
Xyrem cataplexy skin#
Allergic reaction to Xywav: Symptoms of a drug reaction might include a skin rash or hives, fever, wheezing, and shortness of breath.Sleepwalking is more common in children, but your healthcare provider should know about sleepwalking regardless of a person's age. Sleepwalking: This could lead to an injury. Sodium oxybate (Xyrem) o CNS depressant that reduces (instability of sleep-wake flip flop) excessive daytime sleepiness and cataplexy (instability of REM flip-flop) Happening during waking hours (daytime symptoms) o Taken at night, immediately before bed 10-15 mins before falling asleep from the drug.Call your healthcare provider if you or your child are feeling or are considering self-harm or harming others. Mental health problems: This might include confusion, hallucinations (seeing or hearing things that are not real), abnormal thinking, anxiety, feeling upset for no reason, depression, thoughts of harming yourself or others, increased tiredness, and concentration problems.If you already have sleep apnea, lung problems, or breathing problems, you are more likely to experience breathing problems while using Xywav. Breathing problems: This might include trouble breathing, sleep apnea, or slowed breathing.
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