THERE’S BEEN A lot of talk of “revolutionary” drugs lately, thanks to GLP-1s like Ozempic that changed how obesity is treated. Now scientists are trying to replicate a similar groundbreaking feat in the world of sleep. Introducing AD109: a once-daily sleep apnea pill intended to eventually replace clunky CPAP machines.
The experimental drug has generated a lot of buzz. Scientists have been calling it the “holy grail” treatment for sleep apnea, a sleep apnea “star,” among other things. It’s not completely unsubstantiated. The parent company, Apnimed, recently released Phase 3 clinical trial results showing some promising results across people from mild to severe sleep apnea. While not available yet in stores, the FDA has fast-tracked the application with a decision expected in early 2027.
Scientists involved with drug development are hopeful this nightly pill will eliminate most symptoms of sleep apnea, including loud snoring. But when you ask sleep doctors, their reactions are…not as stoked. Some told MH they won’t be prescribing the drug even if it got approved. Here’s why.
First, What Exactly is AD109?
AD109 IS A combination of two medications: aroxybutynin and atomoxetine (Strattera).
Aroxybutynin is a drug that can alter tongue muscle tone during sleep (it’s a chemical cousin of a drug—oxybutynin—that already exists), explains Kelly Johnson-Arbor, MD, a toxicologist at MedStar Health. “Atomoxetine is a medication that enhances chemical transmission of norepinephrine in the brain,” she says, an action that boosts muscle tone in the airway while sleeping. In combination, these drugs “appear to promote airway opening and tongue function during sleep, which may lead to improvement in the signs and symptoms of sleep apnea for some people.”
A May 2026 review published in the American Journal of Respiratory Cell and Molecular Biology goes into more detail. The researchers (affiliated with the pharmaceutical company Apnimed) noted that the drug works because it targets sleep-related neuromuscular dysfunction. Essentially, it stops the brain from relaxing the upper airway muscles too much when you fall asleep.
“These data support neuromuscular dysfunction as a key driver of disease and demonstrate that targeting this pathway can lead to meaningful improvements in objective physiologic measures, including airway obstruction and oxygenation,” says Patrick J. Strollo, Jr., MD, vice chair of medicine for Veterans Affairs at the University of Pittsburgh School of Medicine and one of the clinical trial researchers.
The pill is designed to be taken once a night with the goal of reducing those breathing interruptions and improving oxygen intake.
Does AD109 Work?
RIGHT NOW, THE data looks promising.
Earlier this month in the American Journal of Respiratory and Critical Care Medicine, researchers released the latest phase 3 clinical trial results. They enrolled people with obstructive sleep apnea who could not or would not use a CPAP. Each person was randomly assigned the medication or a placebo to take nightly.
After 26 weeks, scientists found significant improvements in people’s apnea-hypopnea index—a measurement of the average number of breathing disruptions that happen per hour of sleep. People taking AD109 had a 44 percent reduction in symptoms compared to people taking a placebo.
The pill also helped with reducing the condition severity. Nearly 42 percent of individuals taking AD109 moved to a milder category. Almost 18 percent stopped experiencing obstructive sleep apnea symptoms altogether compared to 9.3 percent of people in the placebo group.
For the most part, the medication was well-tolerated. About 21 percent of people stopped taking the drug because of side effects such as dry mouth, nausea, insomnia, and straining to urinate.
What Makes Doctors Skeptical of AD109?
THE PROBLEM IS the hyperboles being used to describe the drug. MH neurologist and sleep advisor W. Christopher Winter, MD, says he’s “very frustrated” at the coverage surrounding this medication.
“It creates confusion for my patients, unrealistic expectations, and flat-out seems to lie at times,” Dr. Winter explains. “That translates into more time I have to spend with individuals undoing what is being done to drum up interest in and potential users of this new drug—which is still a long way off.”
For some doctors, the growing vexation surrounding AD109 really took off after the release of its phase 2 clinical trial results in 2023, dubbed the MARIPOSA study.
“The average patient in the MARIPOSA study had an average of 19.55 breathing problems per hour. By most standards, this is mild-to-moderate sleep apnea,” says Dr. Winter. “Patients in my clinic are often far higher than this in terms of severity.”
According to Dr. Winter, the highest number he’s seen is 155 breathing problems per hour. “It is worth noting that this is a very mild population of sleep apnea patients and not reflective of the general sleep apnea population in a sleep clinic.”
In that trial, AD109 dropped breathing problems from about 20 per hour to about 11 per hour. “Stated another way, they went from having mild-to-moderate sleep apnea to having mild sleep apnea,” Winter says. “While they got 50 percent better, they still have sleep apnea.”
He compares that to taking a pill that makes vision 50 percent better. “Miracle? Not really,” Winter says. “It makes my 20/200 vision 20/100…and despite the miracle pill, I [would] still need glasses.” That doesn’t mean there isn’t potential value in this experimental medication—it’s just not exactly as it’s being portrayed.
Will AD109 Replace CPAP Machines?
DOES THE POTENTIAL approval of AD109 mean there will soon be a junkyard filled with CPAP machines? Not necessarily.
“If AD109 is approved, I would consider it for patients with mild obstructive sleep apnea or for those who have failed CPAP therapy,” says Praveen Rudraraju, MD, pulmonologist and sleep medicine specialist at Northwell Health. “CPAP would continue to be recommended as the first-line treatment, given its established effectiveness and minimal side-effect profile.”
CPAP machines are often considered the go-to treatment for sleep apnea because they do a good job at keeping airways open. The drawback is comfortability—which can interrupt sleep in another way.
“Many people have difficulty using CPAP because the machines are noisy, the masks can be irritating to wear, and side effects—gas and stomach discomfort due to swallowing air—can occur,” says Dr. Johnson-Arbor. “Only 40 to 60 percent of patients who are prescribed CPAP can actually tolerate it over long-term use. Because of this, researchers have investigated medications that target sleep apnea as an alternative treatment to CPAP machines.”
Who Benefits Most From a CPAP Alternative?
AD109 WILL LIKELY be a better choice for people with mild sleep apnea, says Dr. Winter. It would also be a good alternative for people who can’t use CPAP, undergo surgery, or use an oral appliance.
“It is not going to be a particularly useful medication for the vast majority of sleep apnea patients,” he says. “At the end of the day, we ideally want all of our sleep apnea patients to not just be ‘better,’ we want their breathing disturbances to be as normalized as possible.”
One more thing to consider: The injectable medication Zepbound is FDA approved for treating moderate-to-severe obstructive sleep apnea in adults with obesity. (Obesity and sleep apnea often occur together.) Clinical trial results, which looked at patients with moderate to severe sleep apnea, were more pronounced. “By the end of the trial, about 50 percent no longer met the criteria for sleep apnea and therefore no longer needed treatment. They were ‘cured,’” Winter says.
Ultimately, if you have sleep apnea, Winter says it’s best to talk to a healthcare provider about all the options on the table. That includes bringing up the conversation of AD109 if it potentially hits the market next year and what it realistically can and cannot do.
Korin Miller is a freelance writer specializing in general wellness, sexual health and relationships, and lifestyle trends, with work appearing in Men’s Health, Women’s Health, Self, Glamour, and more. She has a master’s degree from American University, lives by the beach, and hopes to own a teacup pig and taco truck one day.
Jocelyn Solis-Moreira, MS is the associate health & fitness for Men’s Health and has previously written for CNN, Scientific American, Popular Science, and National Geographic before joining the brand. When she’s not working, she’s doing circus arts or working towards the perfect pull-up.
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