Results 1 to 10 of about 250 (109)

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

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

Journal of Sleep Research
ABSTRACT Data 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
Luis E. Ortiz, Anne Marie Morse, Michael J. Thorpy, Clete A. Kushida, John Harsh, Thomas Roth, Jennifer Gudeman, Yves Dauvilliers   +7 more
wiley   +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   +4 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

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

RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates [PDF]

Sleep Medicine: X
Objective/Background: Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE ...
Asim Roy, Thomas Stern, John Harsh, J. Douglas Hudson, Akinyemi O. Ajayi, Bruce C. Corser, Emmanuel Mignot, Adrian Santamaria, Anne Marie Morse, Brian Abaluck, Sally Ibrahim, Paula K. Schweitzer, Katie Lancaster, Jordan Dubow, Jennifer Gudeman   +14 more
doaj   +4 more sources

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

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
europepmc   +7 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

Practical Guidance for Initiation and Management of Patients on Once-Nightly Sodium Oxybate for Narcolepsy Treatment: Modified Delphi Panel Consensus Recommendations [PDF]

Neurology and Therapy
Introduction Despite its strong recommendation for treatment of excessive daytime sleepiness (EDS), cataplexy, and disease severity associated with narcolepsy by the American Academy of Sleep Medicine, sodium oxybate (SXB) remains underutilized.
Monique Mulvany, Ellen Wermter, Maggie Lavender, Heidy Merius, Cecile Martin, Amber Burns, Jamie Simmons   +6 more
doaj   +2 more sources