Results 21 to 30 of about 1,677,629 (133)

Application of AASM clinical significance thresholds to once-nightly sodium oxybate for improvement in narcolepsy symptoms

Sleep Medicine
Introduction: Extended-release sodium oxybate taken once at bedtime (LUMRYZ™, sodium oxybate for extended-release oral suspension [FT218; once-nightly sodium oxybate (ON-SXB)]), was evaluated for the treatment of narcolepsy in adults in the phase 3 REST ...
Kushida, Clete A, Dauvilliers, Yves, Dubow, Jordan, Thorpy, Michael J, Morse, Anne M, Roth, Thomas, Gudeman, Jennifer   +6 more
core   +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
  +4 more sources

Composite response with once-nightly sodium oxybate: symptom improvement in participants with narcolepsy type 1 in REST-ON

Sleep Medicine
Introduction: A novel once-nightly formulation of sodium oxybate (ON-SXB; FT218; LUMRYZ™) was investigated in patients with narcolepsy type 1 (NT1) and 2 (NT2) in the phase 3 REST-ON trial.
Kushida, Clete A, Dauvilliers, Yves, Dubow, Jordan, Harsh, John, Thorpy, Michael J, Ortiz, Luis E, Morse, Anne M, Roth, Thomas, Gudeman, Jennifer   +8 more
core   +3 more sources

Consistent efficacy of once-nightly sodium oxybate regardless of patient demographic and baseline disease characteristics

Sleep Medicine
Introduction: Once-nightly formulation of sodium oxybate (ON-SXB; LUMRYZ™) was investigated in patients with narcolepsy in the phase 3 REST-ON trial; treatment with 6, 7.5, and 9 g resulted in significant improvements (all P\u3c0.001) for the coprimary ...
Kushida, Clete A, Dauvilliers, Yves, Dubow, Jordan, Harsh, John, Thorpy, Michael J, Morse, Anne M, Ortiz, Luis E, Roth, Thomas, Gudeman, Jennifer   +8 more
core   +3 more sources

Present and Future of Central Disorders of Hypersomnolence. [PDF]

J Sleep Res
ABSTRACT Central disorders of hypersomnolence (CDH) are rare neurological conditions lumped by excessive daytime sleepiness (EDS) as primary complaint mostly arising at young age, including narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and Kleine‐Levin syndrome (KLS). Advances in clinical and translational research have
Biscarini F, Barateau L, Pizza F, Plazzi G, Dauvilliers Y.   +4 more
europepmc   +2 more sources

Dissolution of Once-Nightly Sodium Oxybate in Soft Foods and Alternative Liquid Reconstitution Vehicles

Clinical Therapeutics
Narcolepsy is a chronic neurologic disorder characterized by excessive daytime sleepiness (EDS) and can occur with or without cataplexy. Once-nightly sodium oxybate (ON-SXB) is approved for the treatment of cataplexy or EDS in patients 7 years of age or older with narcolepsy.
Maggie, Lavender, Anne Marie, Morse, Bahador Mark, Tafazoli, Feri, Ascencion, Ellen, Wermter, Laura B, Herpel, Jennifer, Gudeman, William John, Schaefer, Jason, Vaughn   +8 more
openaire   +2 more sources

Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia

Nature and Science of Sleep, 2022
Michael J Thorpy,1 Isabelle Arnulf,2 Nancy Foldvary-Schaefer,3 Anne Marie Morse,4 Karel Šonka,5 Patricia Chandler,6 Luke Hickey,7 Abby Chen,6 Jed Black,6,8 Amanda Sterkel,6 Dan Chen,9 Richard K Bogan,10 Yves Dauvilliers11,12 1Albert Einstein ...
Thorpy MJ, Arnulf I, Foldvary-Schaefer N, Morse AM, Šonka K, Chandler P, Hickey L, Chen A, Black J, Sterkel A, Chen D, Bogan RK, Dauvilliers Y   +12 more
doaj  

Effects of oxybate dose and regimen on disrupted nighttime sleep and sleep architecture

International audienceMany components of sleep are disrupted in patients with narcolepsy, including sleep quality, sleep architecture, and sleep stability (ie, frequent awakenings/arousals and frequent shifts from deeper to lighter stages of sleep ...
Dauvilliers, Yves, Plazzi, Giuseppe, Roth, Thomas, Black, Jed, Bogan, Richard, K   +4 more
core   +3 more sources

Narcolepsy and rapid eye movement sleep

Journal of Sleep Research, Volume 34, Issue 2, April 2025.
Summary Since the first description of narcolepsy at the end of the 19th Century, great progress has been made. The disease is nowadays distinguished as narcolepsy type 1 and type 2. In the 1960s, the discovery of rapid eye movement sleep at sleep onset led to improved understanding of core sleep‐related disease symptoms of the disease (excessive ...
Francesco Biscarini, Lucie Barateau, Fabio Pizza, Giuseppe Plazzi, Yves Dauvilliers   +4 more
wiley   +1 more source

Diagnostic Value of Psychomotor Vigilance Task for Severe Sleep Inertia in Idiopathic Hypersomnia Versus Other Sleep Disorders Without Sleep Inertia

Journal of Sleep Research, EarlyView.
Diagnostic Value of PVT for Severe Sleep Inertia in Idiopathic Hypersomnia. ABSTRACT Sleep inertia impairs performance upon awakening and may be assessed using the psychomotor vigilance task (PVT). This study aimed to determine optimal PVT lapse cut‐offs at awakening to objectively measure sleep inertia by comparing patients with idiopathic hypersomnia
Elisa Evangelista, Alexandre Derré, Lucie Barateau, Anna Laura Rassu, Sofiene Chenini, Isabelle Jaussent, Yves Dauvilliers   +6 more
wiley   +1 more source