1. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial
- Author
-
Paula K. Schweitzer, Russell Rosenberg, Gary K. Zammit, Mark Gotfried, Dan Chen, Lawrence P. Carter, Hao Wang, Yuan Lu, Jed Black, Atul Malhotra, Kingman P. Strohl, Adam Blackman, Charles George, Colin Shapiro, Heike Benes, Ingo Fietze, Geert Mayer, Peter Young, Gert Jan Lammers, Mansoor Ahmed, Akinyemi Ajayi, James Andry, Roy Artal, Bijan Bastani, Richard Bogan, Bruce Corser, Christopher Drake, Helene Emsellem, Milton Erman, Neil Feldman, Nancy Foldvary, John Hudson, Lois Krahn, Daniel Lorch, James Maynard, Emmanuel Mignot, Michael Neeb, Joseph Ojile, Alvin Thomas Perkins, Asim Roy, Pradeep Sahota, R. Bart Sangal, Andrew Schreiber, Paula Schweitzer, Ralph Steele, Thomas Stern, Sarah Stolz, Kingman Strohl, Todd Swick, Todd J. Swick, Stephen G. Thein, Robert Thomas, Michael Thorpy, Terri Weaver, Kerri Wilks, David Winslow, Paul Wylie, Gary Zammit, and Phyllis Zee
- Subjects
Pulmonary and Respiratory Medicine ,Adult ,Male ,medicine.medical_specialty ,Phenylalanine ,Population ,Disorders of Excessive Somnolence ,Critical Care and Intensive Care Medicine ,Placebo ,law.invention ,Randomized controlled trial ,Dopamine Uptake Inhibitors ,Double-Blind Method ,law ,Internal medicine ,medicine ,Humans ,Adverse effect ,education ,Aged ,education.field_of_study ,Sleep Apnea, Obstructive ,Norepinephrine Plasma Membrane Transport Proteins ,business.industry ,Epworth Sleepiness Scale ,Editorials ,Sleep apnea ,Middle Aged ,medicine.disease ,Clinical trial ,Obstructive sleep apnea ,Female ,Carbamates ,business - Abstract
Rationale: Primary treatment of obstructive sleep apnea can be accompanied by a persistence of excessive sleepiness despite adherence. Furthermore, effectiveness of sleep apnea treatment is limited by poor adherence. Currently available pharmacologic options for the treatment of sleepiness in this population are limited. Objectives: To evaluate the efficacy and safety of solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects, for the treatment of excessive sleepiness in participants with obstructive sleep apnea with current or prior sleep apnea treatment. Methods: This was a double-blind, randomized, placebo-controlled, parallel-group, 12-week trial comparing solriamfetol, 37.5, 75, 150, and 300 mg, with placebo. Measurements and Main Results: Of 476 randomized participants, 459 were included in the prespecified efficacy analyses. Coprimary endpoints (Maintenance of Wakefulness Test sleep latency and Epworth Sleepiness Scale score) were met at all solriamfetol doses (P
- Published
- 2018