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Abstract
In the REST-ON clinical trial (NCT02720744), mean sleep latency on the Maintenance of Wakefulness Test (MWT) was significantly improved with extended-release once-nightly sodium oxybate (ON-SXB) vs placebo (P < 0.001) in participants with narcolepsy. This post hoc analysis assessed response to treatment and improvement in excessive daytime sleepiness.Participants with narcolepsy aged =16 years were randomized 1:1 to receive ON-SXB (4.5 g, week 1; 6 g, weeks 2-3; 7.5 g, weeks 3-8; and 9 g, weeks 9-13) or placebo. Mean sleep latency on the MWT was measured across 5 trials of =30 min each. Post hoc assessments included percentage of participants whose sleep latency improved =5, =10, =15, and =20 min and with a mean sleep latency of 30 min.Significantly more participants receiving ON-SXB vs placebo experienced increased mean sleep latency =5 min (all doses P < 0.001), =10 min (all doses P < 0.001), =15 min (6 and 7.5 g, P < 0.001; 9 g, P < 0.01), and =20 min (6 g, P < 0.01; 7.5 g, P < 0.001; 9 g, P < 0.05). More participants receiving ON-SXB had mean sleep latency of 30 min vs placebo (6 g, 5.7 % vs 0 %, respectively [P < 0.05]; 7.5 g, 10.5 % vs 1.3 % [P < 0.05]; 9 g, 13.2 % vs 5.1 % [P = 0.143]).Significantly more participants who received ON-SXB experienced increased mean sleep latency =5 to =20 min; at the 2 highest doses, >10 % remained awake for the entirety of the MWT. ON-SXB offers a once-at-bedtime treatment option for adults with narcolepsy.
View details for DOI 10.1016/j.sleepx.2024.100113
View details for PubMedID 38774037
View details for PubMedCentralID PMC11107209