Results 1 to 10 of about 377 (154)

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   +6 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   +6 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   +6 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

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   +6 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   +4 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   +11 more sources

Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients with Narcolepsy: A Commentary [PDF]

Neurology and Therapy, 2023
Narcolepsy is associated with disrupted nighttime sleep (DNS). Sodium oxybate (SXB; Xyrem®), administered twice nightly, is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients 7 years or older with narcolepsy.
Russell Rosenberg, Rogelio Braceras, Wayne Macfadden, Shawn Candler, Jed Black, Chad Ruoff   +5 more
doaj   +2 more sources

Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective [PDF]

Nature and Science of Sleep, 2023
Asim Roy,1 Diane Ito,2 Susan Morris,3 Shawn Candler,4 Judi Profant,3 Charles Bae5 1Ohio Sleep Medicine Institute, Dublin, OH, USA; 2Stratevi LLC, Santa Monica, CA, USA; 3Jazz Pharmaceuticals, Palo Alto, CA, USA; 4Jazz Pharmaceuticals, Philadelphia, PA ...
Roy A, Ito D, Morris S, Candler S, Profant J, Bae C   +5 more
doaj   +2 more sources

Evidence of Accidental Dosing Errors with Immediate-Release Sodium Oxybate: Data from the US Food and Drug Administration Adverse Event Reporting System [PDF]

Drugs - Real World Outcomes, 2023
Introduction Sodium oxybate has been approved by the US Food and Drug Administration (FDA) to treat narcolepsy for 20 years; however, the only available products have been immediate-release (IR) formulations given twice nightly—once at bedtime and a ...
Jennifer Gudeman, Danielle Burroughs
doaj   +2 more sources