A new pill may be a game changer for the tens of millions of people in the U.S. who struggle with sleep apnea. Obstructive sleep apnea (OSA) causes repeated interruptions of breathing during sleep when throat muscles relax and block the airway. Sufferers experience daytime sleepiness and difficulty concentrating and if left untreated sleep apnea can lead to more severe conditions, such as hypertension, strokes and heart attacks.

Traditionally managed with lifestyle changes and cumbersome CPAP (continuous positive airway pressure) machines that less than 50% of people adhere to, many OSA patients have struggled to find a solution that is both comfortable and effective.

Now, a new first-of-its kind pill is offering new hope to OSA sufferers. Developed by the pharmaceutical company Apnimed passed Phase 3 clinical trials, according to a press release, the medication, called AD109, is a combination of two medications aroxybutynin and atomoxetine. The two drugs instruct the brain to keep airways open by keeping the muscles of the throat activated.

A significant portion of the 660 adults in the trial who suffered from OSA but couldn’t tolerate CPAP machines, had fewer hourly breathing interruptions while taking AD109 compared with a placebo, says The New York Times.

“With two large Phase 3 studies now demonstrating a consistent and significant efficacy profile for AD109, we are closer to delivering the first oral pharmacotherapy for over 80 million U.S. adults with OSA. Given the scale of unmet need in OSA, where the majority of patients remain untreated, we believe AD109, as a simple once-daily oral drug, has the potential to expand and reshape the treatment landscape,” said Dr. Larry Miller, CEO of Apnimed.

Miller said that just 3% of the study subjects suffered side effects significant enough to stop taking the drug. He added that the company plans to seek approval from the Food and Drug Administration in 2026. Experts say that while CPAP machines are currently the gold standard in treating OSA, the new pill could be an effective alternative for those who can’t tolerate the apparatus. According to the Times, it’s not clear yet how much the drug will cost or if it will be covered by insurance.