Millions of people with obstructive sleep apnea can’t or won’t use a CPAP machine — the standard treatment. A new pill could give them another option.
In the Phase 3 SynAIRgy trial, AD109 — an oral drug combining aroxybutynin and atomoxetine, designed to strengthen the throat muscles that keep the airway open — reduced breathing interruptions by 44%, versus 18% for placebo. The study enrolled 646 adults with mild-to-severe sleep apnea (who had refused or couldn’t tolerate CPAP) across 69 US and Canadian sites over six months. More than 40% of patients improved to a less severe category, and 18% achieved complete disease control. Results were published in the American Journal of Respiratory and Critical Care Medicine.
An alternative, not a replacement
“An oral pill targeting neuromuscular drivers of airway collapse could help address this gap and broaden effective options,” said the University of Pittsburgh’s Dr. Patrick Strollo. Experts frame it as an alternative — especially for CPAP-intolerant patients — rather than a wholesale replacement. Side effects (dry mouth, nausea, insomnia, urinary difficulty) led about 21% to discontinue.
Where it stands
AD109 has FDA Fast Track designation, and a New Drug Application has been submitted, with a potential FDA decision expected in early 2027. If approved, it would be a notable first: a drug that treats the mechanics of sleep apnea. This article summarizes trial results and is not medical advice.