Avadel Pharmaceuticals announced on May 1, 2023 that the FDA granted final approval to LUMRYZ, an extended-released sodium oxybate medication. It is taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.


According to Avadel’s press release, LUMRYZ is the first and only FDA-approved once-at-bedtime oxybate for patients with narcolepsy.

An alternative to twice-nightly oxybate medications, LUMRYZ’s reduced dosing frequency avoids the need for patients to arise at night, which may promote a more natural sleep-wake cycle.

The FDA approval was based on positive results from the Phase 3 REST-ON clinical study.

About narcolepsy

Narcolepsy, a lifelong neurological disorder, disrupts normal sleep-wake cycles, causing patients to feel overwhelmingly tired or experience sudden episodes of muscle weakness known as cataplexy. With a prevalence of about one in 2,000 people, this often-undiagnosed condition can significantly impact daily activities, such as eating, walking and driving, highlighting the importance of recognizing and managing its symptoms.

Read more industry news from the AASM.