Once-A-Day Pill Effective In Treating Sleep Apnea Without CPAP, Clinical Trial Says

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By Dennis Thompson HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

WEDNESDAY, May 20, 2026 — Some people with sleep apnea might be able to shed their CPAP masks in favor of a once-nightly pill, a new study says.

The experimental pill, called AD109, helps treat sleep apnea by making a person’s airways resistant to collapse, researchers say.

In clinical trials, people taking the pill saw their breathing interruptions decrease by about 44% compared to almost 18% for those taking a placebo, researchers reported May 18 in the American Journal of Respiratory and Critical Care Medicine.

Importantly, nearly 18% achieved complete control over their sleep apnea, researchers said.

“These results provide encouraging evidence that targeting neuromuscular dysfunction can translate into meaningful clinical outcomes, aligning with our evolving understanding of the disease biology,” said lead researcher Dr. Patrick John Strollo, a sleep medicine physician at the University of Pittsburgh Medical Center.

Obstructive sleep apnea occurs when a person’s throat muscles relax and block the airway, leading to brief pauses on and off during sleep, according to Mayo Clinic.

Continuous positive airway pressure (CPAP) machines are the gold standard treatment for sleep apnea, but many patients find them intolerable, Strollo said. People must sleep with a mask strapped to their face, next to a machine that can be noisy.

This new pill could provide an alternative to CPAP, researchers said.

“In many other chronic diseases, such as cardiovascular disease, asthma or type 2 diabetes, it would be unthinkable for the majority of diagnosed patients to remain untreated or undertreated. Yet that remains the reality in OSA,” Strollo said in a news release.

“An oral pill that targets the underlying neuromuscular drivers of airway collapse during sleep could help address this gap and broaden the range of effective options for patients who remain untreated today,” he said.

The pill combines two medications, aroxybuytinin and atomoxetine, which together work to resist the tendency of airway muscles to relax during sleep, researchers said.

The new clinical trial involved 318 people with sleep apnea who were randomly chosen to take AD109, along with another 319 people provided a placebo.

Results showed that AD109 reduced sleep apnea severity among more than 40% of patients, and led to complete disease control in nearly 18%.

Patients also had fewer nightly drops in their blood oxygen levels, researchers found.

The drug’s most common side effects were dry mouth, nausea, insomnia and difficulty urinating. About 21% of patients stopped therapy due to side effects.

AD109 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for expedited review. Its developer, Apnimed, has submitted a new drug application to the FDA.

Apnimed funded this clinical trial.

Sources

  • American Thoracic Society, news release, May 18, 2026
  • American Journal of Respiratory and Critical Care Medicine, May 18, 2026

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2026-05-20 21:53

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