Health

Oral medication AD109 reduces sleep apnea breathing events in phase 3 trial

The once-nightly pill could offer a new alternative for patients who cannot tolerate CPAP machines.

Updated Sep 1, 2026 · 13:21 UTC1 reports

The short version

A phase 3 clinical trial found that a once-nightly pill called AD109 reduced breathing interruptions by about 44% in adults with obstructive sleep apnea.
The treatment targets neuromuscular dysfunction to keep airways open, though approximately 21% of study participants stopped taking it due to side effects.
Developer Apnimed has submitted a New Drug Application to the FDA, with a potential target action date in the first quarter of 2027.

The SynAIRgy trial evaluated AD109, a combination of aroxybutynin and atomoxetine, in 646 adults across 69 sites in the U.S. and Canada who could not tolerate or refused CPAP therapy.[ScienceDaily]
Patients taking AD109 experienced a 44% reduction in breathing interruptions per hour on average, compared to an 18% reduction in the placebo group.[ScienceDaily]
More than 40% of patients improved enough to move into a less severe obstructive sleep apnea category, and 18% achieved complete disease control.[ScienceDaily]
The most common side effects reported were dry mouth, nausea, insomnia, and difficulty urinating, leading 21% of patients to discontinue treatment.[ScienceDaily]
Apnimed has submitted its New Drug Application to the FDA, expecting a target action date in the first quarter of 2027 if the application is accepted.[ScienceDaily]

The first quarter 2027 target action date is pending the FDA's official acceptance of the New Drug Application for review.[ScienceDaily]