Lumryz Treatment Associated with Significant Improvements in Mean Sleep Latency According to REST-ON Study

Use of once-nightly (ON) Lumryz (sodium oxybate; Avadel Pharmaceuticals, Dublin, Ireland) was associated with clinically significant improvements in mean sleep latency compared with placebo according to a presentation at the World Sleep 2023 Congress. The results were from a post hoc analysis of data from the REST-ON clinical trial (NCT02720744).

REST-ON was a double-blind, randomized, placebo-controlled study evaluating whether treatment with ON Lumryz was safe and effective in 190 participants aged 16 years and older with narcolepsy type 1 or 2. Participants were randomized 1:1 to receive either placebo or ON Lumryz at a dose of 4.5 g at week 1, 6 g at week 2-3, 7.5 g at week 4-8, and 9 g at week 9-13. The outcomes were mean sleep latency according to the Maintenance of Wakefulness Test (MWT), Clinical Global Impression of Improvement (CGI) rating, and mean number of weekly cataplexy episodes compared to baseline.

• Treatment with ON Lumryz was associated with a greater number of participants achieving a MWT of 30 minutes vs placebo at weeks 3 (5.7% vs 0%; P<.05), 8 (10.5% vs 1.3%; P<.05), and 13 (13.2% vs 5.1%; P=.14).
• More participants receiving ON Lumryz vs placebo showed improved mean sleep latency over baseline at various time points over the trial and with all doses studied.
• At the second highest dose (7.5 g), >10% of participants remained awake for the full MWT.
• Treatment with ON Lumryz vs placebo also was associated with significant improvement in CGI ratings and mean number of weekly cataplexy episodes (both; P<.001).
• The most common adverse reactions were dizziness, nausea, vomiting, headache, and enuresis.

Lumryz’s prescribing information contains a Boxed Warning for central nervous system (CNS) depression and abuse and misuse.