There are those who sleep with a mask on their face connected to a noisy fan. Those who wake up every morning more tired than when they went to bed. Those who are afraid to fall asleep because they know they will stop breathing dozens of times during the night. Sleep apnea is a sneaky disease that destroys the quality of sleep and life of hundreds of millions of people. But something big is about to change.
A pill developed by an American company has just passed phase 3 clinical trials with flying colours, proving to be as effective as traditional CPAPs but infinitely more comfortable.
Sleep Apnea: The End of a Decades-Long Nightmare?
For those who suffer from sleep apnea, every night is a battle. The body stops breathing, the brain wakes up in panic, oxygen is scarce. A vicious cycle that can repeat itself hundreds of times during sleep, leaving you feeling totally exhausted upon awakening.
Until now, the only effective solution was the CPAP therapy, that mask connected to a ventilator that blows pressurized air into your airways. It works, sure, but it's like sleeping in intensive care. About 40% of people abandon it after a few weeks because he can't stand it. Too loud, too uncomfortable, too claustrophobic.
Now the results of the SynAIRgy study, released on May 19, 2025, change everything. AD109, a pill that combines two existing drugs, has been shown to reduce sleep apnea episodes by 56% in 646 patients followed for six months.
How this pill works
The secret of AD109 lies in its ability to “wake up” the throat muscles during sleep. The drug combines atomoxetine (already used for ADHD) and aroxybutynin (a modified version of a medicine for overactive bladder).
Atomoxetine increases levels of norepinephrine, a neurotransmitter that keeps the muscles of the upper airway active. Aroxybutynin blocks receptors that inhibit the hypoglossal nerve, which controls the movement of the tongue. The result? The muscles remain toned during sleep, preventing the collapse of the airways.
The study involved 646 adults with mild to severe sleep apnea at 73 sites in the United States and Canada. Participants took one pill daily at bedtime for 26 weeks.
How do you explain Larry millerCEO Apnimed, the company that developed the drug: “This is a historic moment for millions of people who have struggled for too long with limited treatment options.”
The results that give hope
The numbers from the SynAIRgy study are impressive. 22% of patients treated with AD109 achieved complete disease control, defined as fewer than five apnea episodes per hour. In the placebo group, this percentage was much lower.
But it's not just statistics. The drug also significantly improved oxygenation during sleep, reducing the depth and duration of periods of low oxygenation, which are most dangerous for the heart and brain.
Sigrid Veasey, a sleep physician at the University of Pennsylvania, is not shy about his excitement: “It’s clear that this combination of drugs reduces obstructive apnea events and improves oxygen levels during sleep. It’s exciting.”
Sleep Apnea Pill: When Will It Arrive in Pharmacies?
Apnimed has already announced that it will submit an application for approval to the US FDA by early 2026. As reported by the journal Science, the full results of the study will be presented in the fall at a scientific conference.
A second Phase 3 study, called LunAIRo and lasting 12 months, is expected to conclude this summer. If the results are confirmed, AD109 could become the first oral drug approved specifically for sleep apnea.
The questions that remain open
Despite the enthusiasm, some doctors remain cautious. Najib Ayas, of the University of British Columbia and principal investigator at one of the study's centers, points out that
“It’s not yet clear whether the drug actually affects patients’ symptoms, such as daytime sleepiness. We want patients to feel better, not just have a reduction in respiratory events.”
Other experts question what the long-term effects might be. Atomoxetine is a stimulant and can slightly increase heart rate and blood pressure. As we discussed in our article on sleep monitoring devices, research in this field is experiencing a moment of great excitement.
A new era for sleep medicine
Clear Yaggi, director of the Sleep Medicine Program at Yale University, sees AD109 as the beginning of a new era: “Instead of a ‘CPAP for all’ approach, we are really entering the era of precision sleep medicine. This drug is a big step in that direction.”
The idea that some patients may be completely free of CPAP, while others may combine different therapeutic approaches, opens up new scenarios. Alternatives to CPAP already exist, but none had ever demonstrated such widespread and immediate effectiveness.
Monica Mallampalli, president of the Alliance of Sleep Apnea Partners, “sleep apnea should be considered a top public health priority. It is a serious, common, chronic disease that affects people of all ages, ethnicities, and body weights. There is a tremendous need for new treatment options.”
One billion people in the world could soon have a simple, effective and comfortable alternative to finally sleep soundly. The pill that for decades was only a dream, is now almost a reality.
