Sleep apnea sufferers may soon have a new path to a good night’s sleep.
A Massachusetts biotech startup is preparing to file for FDA approval of a once-nightly pill that could become the first medication approved to treat obstructive sleep apnea (OSA).
Approximately 30 million U.S. adults suffer from the serious sleep disorder, in which breathing stops and starts throughout the evening, according to experts.
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They are two types of the disorder: obstructive sleep apnea (OSA) and central sleep apnea. With OSA, the most common type, breathing stops due to a physical blockage of the airway, according to the National Institutes of Health (NIH).
Central sleep apnea occurs when the brain cannot send the normal signals to breathe, sometimes due to health disorders.
“The intermittent stopping of breathing leads to brief awakenings in people who suffer from OSA,” sleep expert Paul Muchowski, Ph.D., founder and CEO of Defined Sleep in San Francisco, told Fox News Digital. “These awakenings disrupt the normal architecture of sleep, ultimately leading to a decrease in deep, restorative sleep.”
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People with the condition often wake up feeling unrefreshed and fatigued, leading to effects like irritability, lack of concentration, decreased cognition and memory, and headaches, according to the expert.
“It also increases risk for heart trouble, strokes and neurodegenerative diseases like Alzheimer’s and Parkinson’s,” he added.
Sleep apnea is diagnosed by a sleep study, where sensors are placed on the body to monitor the activity of the heart, lungs and brain to assess the quality of sleep, according to Cleveland Clinic.
“Surprisingly, many folks who have sleep apnea are unaware they have it,” Muchowski noted.
The standard first-line treatment for OSA is a continuous positive airway pressure (CPAP) machine, which uses a mask to deliver pressurized air that keeps the airway open during sleep.
Many people find CPAP machines too cumbersome to use consistently, and as a result may not seek treatment even after being diagnosed with sleep apnea, according to Muchowski.
In 2024, the FDA approved the popular weight-loss drug Zepbound for the treatment of moderate-to-severe OSA, but only for adults who are obese even with a low-calorie diet and increased physical activity.
This drug does not target the underlying cause of OSA, but simply lowers weight in people, which can sometimes lead to a decrease in the sleep disorder, Muchowski noted.
If conservative treatments fail, more invasive options — such as surgery to remove enlarged tonsils — may be considered, experts say.
Apnimed, a pharmaceutical company based in Cambridge, Massachusetts, that focuses on treating sleep apnea, has developed a medication known as AD109, designed as an alternative for patients who cannot tolerate CPAP machines.
There is currently no FDA-approved oral medication specifically indicated for obstructive sleep apnea, the company noted.
“A pill for sleep apnea has always been the long sought-after holy grail for sleep researchers around the world,” said Muchowski, who was not involved in the drug research.
In those living with mild, moderate and severe OSA, AD109 helps to keep the airway more open during sleep by targeting the underlying dysfunction between the brain and throat muscles, a representative for Apnimed told Fox News Digital.
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The once-daily pill combines two drugs: aroxybutynin, which controls muscle signals, and atomoxetine, which increases levels of norepinephrine. (Norepinephrine is a hormone and neurotransmitter that helps regulate alertness, attention, heart rate, blood pressure and the “fight-or-flight” response, according to Cleveland Clinic.)
“Together, they are designed to work synergistically to help stabilize the upper airway during sleep, improving breathing and oxygenation overnight,” the company added.
In phase 3 clinical trials, participants who received the drug had a significant reduction in the average number of hourly breathing interruptions compared with those who had a placebo.
In one phase 3 study, participants achieved a 55.6% mean reduction in nightly sleep apnea events and also significantly improved oxygenation after 26 weeks. A second phase 3 study showed similar outcomes.
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The most frequently reported side effects were dry mouth and insomnia, but no serious adverse events related to AD109 were reported, according to the company.
“Additional safety details will be included in future peer-reviewed publications,” they added.
The research supporting AD109 as a potential treatment for OSA looks “very solid,” according to Muchowski.
“If this potential treatment is approved by the FDA to treat OSA, it could potentially help tens of millions of people worldwide to sleep better and avoid all of the negative consequences of OSA,” he added.
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Apnimed plans to submit a new drug application to the FDA in the first half of 2026. While timelines can vary, a standard review typically takes around 10 months, which means the pill could be on the market in early 2027.
“Our focus right now is on completing that process rigorously and responsibly,” the company said.
