The famous pill against sleep apnea “without serious side effects” takes a new step

Sleep apnea remains one of the most ill -treated chronic diseases to date, despite its devastating effects on cardiovascular health, memory or mood. If CPAP machines are effective, they are often badly experienced. An American laboratory, Apnimed, Develops a pill, AD109, supposed to wake up the muscles of the respiratory tract during the night without any mask being necessary. The results have just fallen: two consecutive phase 3 trials are conclusive.

Sleep apnea: oral treatment shows its long -term effectiveness

The figures are there, and they are solid. After a first trial named Synairgy, Apnimed has just published the results of Lunairo, a second test of phase 3 carried out on 660 patients with moderate to severe obstructive apnea. This new oral treatment, AD109, combines two existing molecules – atomoxetine (used against ADHD) and aroxobutynin (anticholinergic) – to stimulate the muscle tone of the throat during sleep.

In the Lunairo study, patients who took AD109 for 26 weeks saw their index of apnea-hypopnea (AHI) fall on average by 46.8 %, against only 6.8 % on placebo. Better still: one in five patients reached an AHI less than 5, that is to say an almost complete control of his sleep apnea. This figure climbs to 22.3 % in the Synairgy trial, which even displayed an average reduction of 55.6 % of the number of apneas.

“The results are extremely encouraging, especially in terms of security”explains Dr. Caroline Yau, medical director of Apnimed. “We have observed very few unwanted events related to treatment, and no serious effect.” Over time (up to 51 weeks for certain participants), the beneficial effects are maintained, especially on night oxygenation.

Sleep apnea affects almost a billion people worldwide, and remains very largely underdiagnosed. Even among the patients identified, the majority abandoned the CPAP, often for reasons of comfort. AD109 aims precisely these orphaned patients with viable treatment. APNIMED plans to submit an authorization request (NDA) to the FDA in early 2026.

“We now have two independent, robust studies, which confirm the effectiveness of the drug”underlines Dr. Yau. If the American agency validates, it would be the first oral treatment never approved for this disease. A small tablet, and maybe a big step for millions of breathless sleepers.