A promising new drug could put an end to cumbersome CPAP machines and allow millions of Americans to breathe easy and sleep soundly.

Researchers at the biopharm company Apnimed have been developing a sleep apnea drug called AD109. After various clinical trials, they are preparing to file for FDA approval.

“A pill for sleep apnea has always been the holy grail,” Dr. Andrew Wellman, a Harvard sleep researcher, told Forbes, noting that over the past several years, at least 40 drug candidates have been tested for obstructive sleep apnea (OSA) without success.

Perhaps the grail has been found. If approved, AD109 could hit the market early next year.

It could prove to be a saving grace for the roughly 80 million Americans who suffer from sleep apnea. The most common form of the sleep disorder is OSA.

In OSA patients, the upper airway partially or completely closes during sleep, blocking airflow to the lungs and causing breathing to repeatedly start and stop.

In addition to risks like early death, high blood pressure, stroke, heart disease, Type 2 diabetes and possibly cognitive decline and dementia, OSA contributes to a serious decline in sleep quality.

The novel AD109 aims to combat the condition with a combination of oxybutynin, which treats overactive bladder, and atomoxetine, used to treat ADHD.

Both drugs are designed to help keep people asleep, and in tandem, can keep a person’s airway from collapsing during the night.

According to researchers, AD109 activates the brain stem enough to prevent full muscle relaxation in the throat while allowing the brain to sleep.

The testing and refinement of AD109 have gone on for close to a decade. Last year, Phase 3 clinical studies demonstrated that the drug improved patients’ breathing overnight, reducing the severity of sleep apnea symptoms by 47% by 26 weeks of use.

Reported side effects include insomnia and dry mouth.

The current and most common protocol for OSA treatment is a CPAP, which stands for “continuous positive airway pressure,” a machine that forces air into the body via a face mask.

Because CPAPs are cumbersome and expensive, many patients with sleep apnea don’t use them. Experts maintain that a quarter of OSA patients are “non-compliant” with the machines.

Notwithstanding the reluctance many patients show to CPAPs, no treatment compares to the efficacy of these machines, which supply users with continuous air throughout the night. 

In 2024, the FDA approved Eli Lilly’s Zepbound to treat moderate-to-severe OSA in adults with obesity.

While Zepbound can help patients shed pounds, and losing weight can, in turn, help obese individuals with OSA improve their breathing, the medication does not directly treat sleep apnea.

For OSA sufferers looking to avoid prescription drugs and CPAP machines, lifestyle changes like weight loss, less alcohol intake and smoking cessation have proven beneficial.

For others, the cure may be a matter of what’s on their fork; researchers from Flinders University in Australia found that those who adopted a vegetarian or vegan diet were nearly 20% less likely to develop OSA than their carnivorous counterparts.