Lumryz
sodium oxybate
Manufacturer: Flamel Ireland Limited dba Avadel Ireland
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (3)
treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
indicated for the treatment of cataplexy in patients 7 years of age and older with narcolepsy
Population: pediatric ≥7 years and older
indicated for the treatment of excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
Population: pediatric ≥7 years and older
Indications & Usage
1 INDICATIONS AND USAGE LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ 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 ( 1 ).
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