Promising Results in Sleep Apnea Pill Could Eliminate Patient Need for Uncomfortable CPAP Machine
Leaving obstructive sleep apnea untreated raises the risk of cardiovascular disease and Type 2 diabetes. A new pill could provide relief for the millions of Americans who suffer from this dangerous sleep disorder, which disrupts the ability to breathe while sleeping and affects some 30 million people in the U.S., according to the American Academy of Sleep Medicine.
Currently, a machine known as a Continuous Positive Airway Pressure (CPAP) can help regulate breathing, but these machines can be unpleasant, have been recalled over health concerns, and can cost up to $1,000. Now, AD109, a nightly pill, could offer a game-changing alternative form of treatment, as shown by new results of a large clinical trial.
AD109 is the first medication to treat the most common form of sleep apnea, known as obstructive sleep apnea. This form occurs when the muscles in the throat relax, causing tissue to press on the windpipe and block air, according to Ohio’s Cleveland Clinic. The pill works by stimulating the muscles that keep the airway open, decreasing breathing disruptions.
In the randomized trial, more than 40 percent of patients saw their disease severity improve, and 18 percent saw their sleep return to normal. “It’s pretty clear that this medication combination is reducing obstructive sleep apnea events. And it’s reducing the severity of oxygen drops during sleep. That is exciting,” said Sigrid Veasey, a sleep physician at the University of Pennsylvania who was not involved with the study. “The effects are robust and have a good scientific basis.”
AD109 is a combination of two existing medications that keep the upper airway open, including the ADHD drug atomoxetine and aroxybutynin, a chemically altered form of a drug used to treat an overactive bladder. The trial ran for six months at 69 sites in the U.S. and Canada, involving 646 adults with obstructive sleep apnea who could not use CPAP machines.
Patients taking the drug saw the number of interruptions to their breathing decrease by 44 percent during the trial period, compared with 18 percent in the placebo group. The number of times their blood oxygen levels fell also improved, as well as their oxygen deficiency. As with nearly all medications, there were some side effects. The most common were dry mouth, nausea, insomnia, and difficulty urinating, and 21 percent of patients discontinued taking the pill.
CPAP machines also have side effects, including nasal congestion, dry eyes, skin irritation or sores from the mask, short-term chest pain, and claustrophobia. These issues cause nearly half of users to discontinue use within three years, according to past research. However, there are other treatments available, such as oral appliances and surgery.
Obstructive sleep apnea is undertreated, partly due to poor response to treatment. Some 80 percent of adults remain undiagnosed, the academy says. Ignoring treatment could lead to life-threatening conditions such as heart attack, stroke, Type 2 diabetes, chronic pain, obesity, and acid reflux. Men and people over 65 are more commonly affected.
The new pill could fill this treatment gap, according to the study’s author, Dr. Patrick John Strollo, a sleep medicine physician at the University of Pittsburgh Medical Center. While Eli Lilly’s weight loss shot Zepbound was approved for sleep apnea by the U.S. Food and Drug Administration in 2024, its use is limited to people with obesity. AD109 benefits people with and without obesity.
“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 [obstructive sleep apnea],” Strollo said. “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.” AD109 has received a fast track designation from the FDA.
