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First Oral Sleep Apnea Drug Shows Promise in Phase 3 Trial

Written by Ted Samson
Posted on September 10, 2025

A new once-daily oral medication has shown promising results in a late-stage clinical trial for obstructive sleep apnea (OSA). In a phase 3 study, people taking the drug AD109 experienced a 55 percent reduction in the number of breathing interruptions during sleep compared with those taking a placebo (inactive treatment). Researchers also reported better oxygen levels and fewer cases of severe disease in the people taking the new medication.

What Is Obstructive Sleep Apnea?

OSA is a chronic condition where the upper airway repeatedly collapses during sleep, causing breathing to stop and restart. This can lower oxygen levels and disrupt rest. OSA affects an estimated 80 million people in the U.S. and up to 1 billion worldwide. People living with certain health conditions, including obesity, are at a higher risk of developing OSA.

Currently, the most common treatment is continuous positive airway pressure (CPAP), a machine worn during sleep that keeps the airway open. Researchers have found CPAP machines can provide short- and long-term benefits for people with OSA. However, some people find these machines uncomfortable, cumbersome, or difficult to use.

What the Study Found

For the phase 3 trial, 646 adults took either AD109 or a placebo pill at bedtime for six months. The study included people with mild, moderate, and severe OSA, as well as people with and without obesity.

Among key findings:

  • Researchers observed a 55.6 percent drop in apnea-hypopnea index, a measure of sleep interruptions.
  • About half of the participants (51 percent) moved to a lower OSA disease severity category.
  • More than 1 in 5 (22 percent) achieved full disease control, defined as less than five sleep apnea events per hour.

The treatment was generally well tolerated, with no serious side effects linked to the drug.

Why This Matters for People With Obesity

People with obesity are more likely to develop OSA, which can increase the risk of conditions including heart disease and type 2 diabetes. Current treatments like CPAP can be effective but difficult to stick with. If approved, AD109 could become the first pill that treats the root cause of OSA by strengthening airway muscles during sleep.

The drug manufacturer Apnimed plans to seek approval from the U.S. Food and Drug Administration (FDA) in early 2026, meaning the medication may still be several months away from being available.

In the meantime, if you or a loved one is living with OSA or concerned about sleep quality, talk with your doctor about current treatment options and ways to improve rest.

Learn about how sleep disruptions can affect your health, as well as ways to boost your energy.

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