Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial

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 a...

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Bibliographic Details
Published in:American journal of respiratory and critical care medicine 2019-06, Vol.199 (11), p.1421-1431
Main Authors: 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
Format: Article
Language:English
Subjects:
Adult
Adults
Aged
Carbamates - therapeutic use
Cardiovascular disease
Clinical trials
Disorders of Excessive Somnolence - drug therapy
Disorders of Excessive Somnolence - etiology
Dopamine
Dopamine Uptake Inhibitors - therapeutic use
Double-Blind Method
Drug dosages
Evidence-based medicine
FDA approval
Female
Heart
Humans
Hypoxia
Male
Medicine
Middle Aged
Norepinephrine Plasma Membrane Transport Proteins - drug effects
Original
Phenylalanine - analogs & derivatives
Phenylalanine - therapeutic use
Quality of life
Shift work
Sleep apnea
Sleep Apnea, Obstructive - complications
Sleep disorders
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Summary: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. 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. This was a double-blind, randomized, placebo-controlled, parallel-group, 12-week trial comparing solriamfetol, 37.5, 75, 150, and 300 mg, with placebo. 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 (  
ISSN:1073-449X
1535-4970
1535-4970
DOI:10.1164/rccm.201806-1100OC