학술논문
Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial
Document Type
article
Author
Schweitzer, Paula K; Rosenberg, Russell; Zammit, Gary K; Gotfried, Mark; Chen, Dan; Carter, Lawrence P; Wang, Hao; Lu, Yuan; Black, Jed; Malhotra, Atul; Strohl, Kingman P; Blackman, Adam; George, Charles; Shapiro, Colin; Benes, Heike; Fietze, Ingo; Mayer, Geert; Young, Peter; Lammers, Gert Jan; Ahmed, Mansoor; Ajayi, Akinyemi; Andry, James; Artal, Roy; Bastani, Bijan; Bogan, Richard; Corser, Bruce; Drake, Christopher; Emsellem, Helene; Erman, Milton; Feldman, Neil; Foldvary, Nancy; Hudson, John; Krahn, Lois; Lorch, Daniel; Maynard, James; Mignot, Emmanuel; Neeb, Michael; Ojile, Joseph; Perkins, Alvin Thomas; Roy, Asim; Sahota, Pradeep; Sangal, R Bart; Schreiber, Andrew; Schweitzer, Paula; Steele, Ralph; Stern, Thomas; Stolz, Sarah; Strohl, Kingman; Swick, Todd; Swick, Todd J; Thein, Stephen G; Thomas, Robert; Thorpy, Michael; Weaver, Terri; Wilks, Kerri; Winslow, David; Wylie, Paul; Zammit, Gary; Zee, Phyllis
Source
American Journal of Respiratory and Critical Care Medicine. 199(11)
Subject
Language
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