Results 1 to 10 of about 538 (147)

Once-nightly sodium oxybate (FT218) improved symptoms of disrupted nighttime sleep in people with narcolepsy: a plain language summary [PDF]

Journal of Comparative Effectiveness Research, 2023
What is this summary about? This is a plain language summary of a published article in the journal CNS Drugs. Narcolepsy is a rare sleep condition.
Thomas Roth, Michael J Thorpy, Clete A Kushida, Matthew Horsnell, Jennifer Gudeman   +4 more
doaj   +5 more sources

How once-nightly sodium oxybate is processed in the body in healthy volunteers: a plain language summary [PDF]

Journal of Comparative Effectiveness Research
What is this summary about? This is a plain language summary of an article originally published in the journal Sleep Medicine. Narcolepsy is a sleep condition in which people have periods of extreme sleepiness during the day.
Richard Bogan, Michael J Thorpy, Sarah Berkowitz, Jennifer Gudeman   +3 more
doaj   +5 more sources

Cataplexy response with extended-release once-nightly sodium oxybate: Post hoc responder analyses from the phase 3 REST-ON clinical trial [PDF]

Sleep Medicine: X
Background: Once-nightly sodium oxybate (ON-SXB), an extended-release oxybate formulation, yielded significant (P 
Michael J. Thorpy, Clete A. Kushida, Richard Bogan, Akinyemi O. Ajayi, Bruce C. Corser, Jennifer Gudeman   +5 more
doaj   +5 more sources

Response to: Once-nightly sodium oxybate (FT218) in the treatment of narcolepsy: a letter to the editor commenting on the recent publication by C. Kushida et al. [PDF]

Sleep, 2022
FT218 is an investigational, once-nightly, modified-release formulation of sodium oxybate (SO). SO effectively treats excessive daytime sleepiness and cataplexy in patients with narcolepsy. Current approved SO formulations, at effective doses of 6, 7.5, and 9 g, require twice-nightly divided dosing, with the first dose taken at bedtime and the second 2.
Kushida CA, Roth T, Shapiro CM, Roy A, Rosenberg R, Ajayi AO, Seiden D, Gudeman J.   +7 more
europepmc   +12 more sources

Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. [PDF]

Sleep, 2022
Abstract Study Objectives To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial. Methods Narcolepsy patients aged ≥16 years ...
Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, Dauvilliers Y.   +10 more
europepmc   +5 more sources

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 [PDF]

Sleep Medicine: X
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 
Michael J. Thorpy, Clete A. Kushida, Richard Bogan, John Winkelman, Maurice M. Ohayon, Colin M. Shapiro, Jennifer Gudeman   +6 more
doaj   +3 more sources

Once-Nightly Sodium Oxybate Meets American Academy of Sleep Medicine Criteria for Treatment of Narcolepsy. [PDF]

J Sleep Res
ABSTRACTData from the REST‐ON trial were not available before the 2021 American Academy of Sleep Medicine (AASM) clinical practice guideline update, which included a literature review through August 2020. This post hoc analysis from REST‐ON assessed participants who achieved clinically significant improvements on individual AASM clinical significance ...
Ortiz LE, Morse AM, Thorpy MJ, Kushida CA, Harsh J, Roth T, Gudeman J, Dauvilliers Y.   +7 more
europepmc   +3 more sources

Improvements in daytime sleepiness and disrupted nighttime sleep with once-nightly sodium oxybate in people with narcolepsy type 1 and type 2: a plain language summary [PDF]

Journal of Comparative Effectiveness Research
What is this summary about? This is a plain language summary of a published article in the journal Sleep. Narcolepsy is a sleep condition that has 2 different subtypes: narcolepsy type 1 and narcolepsy type 2. These are called NT1 and NT2 for short.
Yves Dauvilliers, Thomas Roth, Richard Bogan, Michael J Thorpy, Anne Marie Morse, Fèri Ascencion, Jennifer Gudeman   +6 more
doaj   +3 more sources

0411 Once-Nightly Sodium Oxybate Dose Titration and Tolerability: Interim Data From RESTORE

Sleep, 2022
Abstract Introduction Extended-release, once-nightly sodium oxybate (ON-SXB; FT218) is under FDA review for the treatment of adults with narcolepsy. RESTORE, an ongoing, open-label extension/switch study (NCT04451668), evaluates long-term ON-SXB safety and tolerability.
Asim Roy, Brian Abaluck, Thomas Stern, Clete Kushida, David Seiden, Jordan Dubow, Jennifer Gudeman   +6 more
semanticscholar   +6 more sources

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. [PDF]

CNS Drugs, 2022
Sodium oxybate has been recognized as a gold standard for the treatment of disrupted nighttime sleep due to narcolepsy. Its short half-life and immediate-release formulation require patients to awaken 2.5–4 h after their bedtime dose to take a second ...
Roth T, Dauvilliers Y, Thorpy MJ, Kushida C, Corser BC, Bogan R, Rosenberg R, Dubow J, Seiden D.   +8 more
europepmc   +2 more sources