One-Night Pill Cuts Sleep Apnea Breathing Interruptions by 44%

A once-nightly oral pill called AD109 (aroxybutynin plus atomoxetine) reduced the apnea–hypopnea index by about 44% in a six-month phase 3 trial across 646 adults who could not tolerate CPAP, with improvements in nighttime oxygen metrics and overall disease severity (over 40% moved to a less severe category and 18% achieved complete control). Side effects were generally mild (dry mouth, nausea, insomnia, difficulty urinating), with about 21% discontinuing. An NDA has been submitted and FDA Fast Track designation suggests a potential 1Q 2027 action date if accepted for review.