Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

Summary

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

Timeline

Start

2016-11-17

Primary completion

2020-03-25

Completion

2020-03-25

Publications

• Ortiz LE, Morse AM, Thorpy MJ, Kushida CA, Harsh J, Roth T, Gudeman J, Dauvilliers Y. Once-Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy. J Sleep Res. 2026 Apr;35(2):e70189. doi: 10.1111/jsr.70189. Epub 2025 Aug 25.
• Roth T, Thorpy MJ, Kushida CA, Gudeman J. Efficacy of Once-Nightly Sodium Oxybate in Patients with Narcolepsy: Post Hoc Analyses of Sensitivity, Effect Size, and Numbers Needed to Treat from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):61-70. doi: 10.1007/s40263-025-01160-0. Epub 2025 Mar 20.
• Krahn L, Roy A, Winkelman JW, Morse AM, Gudeman J. Assessing Early Efficacy After Initiation of Once-Nightly Sodium Oxybate (ON-SXB; FT218) in Participants with Narcolepsy Type 1 or 2: A Post Hoc Analysis from the Phase 3 REST-ON Trial. CNS Drugs. 2025 Mar;39(Suppl 1):53-59. doi: 10.1007/s40263-024-01143-7. Epub 2025 Mar 20.
• Dauvilliers Y, Roth T, Bogan R, Thorpy MJ, Morse AM, Roy A, Gudeman J. Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial. Sleep Med. 2024 Dec;124:209-216. doi: 10.1016/j.sleep.2024.09.024. Epub 2024 Sep 17.
• Roth T, Morse AM, Bogan R, Roy A, Gudeman J, Dauvilliers Y. Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial. Clin Ther. 2024 Oct;46(10):791-798. doi: 10.1016/j.clinthera.2024.07.010. Epub 2024 Aug 16.
• Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D. Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial. CNS Drugs. 2022 Apr;36(4):377-387. doi: 10.1007/s40263-022-00904-6. Epub 2022 Apr 5.
• Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Sleep. 2022 Jun 13;45(6):zsab200. doi: 10.1093/sleep/zsab200.

Drugs

Indications