Sleep Apnea Sufferers May Soon Have First FDA-Approved Medication

Sleep apnea sufferers may soon have a new path to a good night’s sleep. A Massachusetts biotech startup, Apnimed, is preparing to file for FDA approval of a once-nightly pill that could become the first medication specifically approved to treat obstructive sleep apnea (OSA).

Approximately 30 million U.S. adults suffer from this serious sleep disorder, in which breathing stops and starts throughout the night, leading to fragmented sleep patterns and a host of health complications.

“Surprisingly, many folks who have sleep apnea are unaware they have it,” said Paul Muchowski, Ph.D., founder and CEO of Defined Sleep in San Francisco. This lack of awareness remains a significant challenge in addressing the condition nationwide.

There are two main types of sleep apnea. Obstructive sleep apnea (OSA), the most common form, occurs when breathing stops due to a physical blockage of the airway. Central sleep apnea, less common, happens when the brain fails to send proper breathing signals, often due to underlying health disorders.

The health implications extend far beyond poor sleep quality. “The intermittent stopping of breathing leads to brief awakenings in people who suffer from OSA,” Muchowski explained. “These awakenings disrupt the normal architecture of sleep, ultimately leading to a decrease in deep, restorative sleep.”

People with the condition typically wake up feeling unrefreshed and fatigued, experiencing irritability, concentration difficulties, decreased cognition, memory problems, and headaches. More seriously, untreated sleep apnea increases the risk of heart disease, strokes, and neurodegenerative conditions like Alzheimer’s and Parkinson’s disease.

Sleep apnea is diagnosed through sleep studies, where sensors monitor the activity of the heart, lungs, and brain to assess sleep quality. However, the standard treatment has significant compliance issues.

Currently, the primary 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. Unfortunately, many patients find CPAP machines too cumbersome and uncomfortable, leading to poor adherence rates even after diagnosis.

In 2024, the FDA approved the weight-loss drug Zepbound for treating moderate-to-severe OSA, but only for obese adults who maintain a low-calorie diet and increased physical activity. This medication doesn’t target the underlying cause of OSA but helps by reducing weight, which can sometimes alleviate symptoms.

When conservative treatments fail, doctors may recommend more invasive options, such as surgery to remove enlarged tonsils.

Apnimed’s experimental drug, AD109, represents a potential breakthrough in sleep apnea treatment. “A pill for sleep apnea has always been the long sought-after holy grail for sleep researchers around the world,” Muchowski noted.

The once-daily medication combines two existing drugs: aroxybutynin, which controls muscle signals, and atomoxetine, which increases levels of norepinephrine – a hormone and neurotransmitter that helps regulate alertness, attention, heart rate, blood pressure, and the “fight-or-flight” response.

“Together, they are designed to work synergistically to help stabilize the upper airway during sleep, improving breathing and oxygenation overnight,” a representative from Apnimed told reporters.

Clinical results have been promising. In phase 3 trials, participants who received AD109 experienced a significant reduction in breathing interruptions compared to those given a placebo. One study demonstrated a 55.6% mean reduction in nightly sleep apnea events and improved oxygenation after 26 weeks, with a second phase 3 study showing similar outcomes.

The most frequently reported side effects were dry mouth and insomnia, but no serious adverse events related to AD109 were reported. “Additional safety details will be included in future peer-reviewed publications,” the company added.

The research supporting AD109 as a potential treatment for OSA looks “very solid,” according to Muchowski, who was not involved in the drug’s development. “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.”

Apnimed plans to submit a new drug application to the FDA in the first half of 2026. While approval timelines vary, a standard review typically takes around 10 months, meaning the pill could reach the market by early 2027.

If approved, AD109 would represent the first oral medication specifically designed to treat the underlying mechanisms of obstructive sleep apnea, potentially transforming treatment options for millions of patients worldwide who struggle with current therapies.