Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial.

Background: 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.
Methods: 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.
Results: 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]).
Conclusions: 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.
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Michael J. Thorpy reports a relationship with Axsome Therapeutics that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Balance Therapeutics that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Eisai that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Harmony BioSciences that includes: consulting or advisory. Michael J. Thorpy reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with NLS Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Suven Life Sciences Ltd. that includes: consulting or advisory. Michael J. Thorpy reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co that includes: consulting or advisory. Clete A. Kushida reports a relationship with Avadel Pharmaceutical that includes: consulting. Clete A. Kushida reports a relationship with XW Pharma that includes: consulting. Richard Bogan reports a relationship with WaterMark Medical and Health Humming LLC that includes: equity or stocks. Richard Bogan reports a relationship with WaterMark Medical that includes: board membership. Richard Bogan reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory, funding grants, and speaking and lecture fees. Richard Bogan reports a relationship with Harmony BioSciences that includes: consulting or advisory and speaking and lecture fees. Richard Bogan reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co. that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Oventus that includes: consulting or advisory. Richard Bogan reports a relationship with BresoTec that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004326Bayer that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100016198Idorsia that includes: funding grants. Richard Bogan reports a relationship with Suven Life Sciences Ltd. that includes: funding grants. Richard Bogan reports a relationship with Balance Therapeutics that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100010902Vanda that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004334Merck that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100003769Eisai that includes: funding grants and speaking and lecture fees. Richard Bogan reports a relationship with Fresca that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100013410LivaNova that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004337Roche that includes: funding grants. Richard Bogan reports a relationship with Sommetrics that includes: funding grants. John Winkelman reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. John Winkelman reports a relationship with Emalex Biosciences that includes: consulting or advisory. John Winkelman reports a relationship with Noctrix Health that includes: consulting or advisory. John Winkelman reports a relationship with Disc Medicine that includes: consulting or advisory. John Winkelman reports a relationship with 10.13039/501100016198Idorsia Pharmaceuticals that includes: consulting or advisory. John Winkelman reports a relationship with 10.13039/100004334Merck & Co. that includes: funding grants. John Winkelman reports a relationship with 10.13039/100016473American Regent that includes: funding grants. John Winkelman reports a relationship with 10.13039/100000026NIDA that includes: funding grants. John Winkelman reports a relationship with 10.13039/100004087RLS Foundation that includes: funding grants. John Winkelman reports a relationship with Baszucki Brain Research Fund that includes: funding grants. Maurice M. Ohayon reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Maurice M. Ohayon reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co. that includes: consulting or advisory. Maurice M. Ohayon reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory. Colin M. Shapiro reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and speaking and lecture fees. Colin M. Shapiro reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory and speaking and lecture fees. Jennifer Gudeman reports a relationship with Avadel Pharmaceuticals that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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