The CPAP machine may become a thing of the past. Millions of Americans use them to breathe easily as they sleep. But they are cumbersome and noisy. A new pill could put an end to their use.
“A pill for sleep apnea has always been the holy grail,” said Dr. Andrew Wellman, a Harvard sleep researcher. He added that 40 drugs have been tested in the last few years without success.
Now, a drug called AD109 has been through clinical trials and is seeking FDA approval. AD109 activates the brain stem so that muscles can’t fully relax — preventing airways from closing — but not enough so that the brain can’t sleep. In studies, it reduced symptoms by 47 percent.
CPAP machines are highly effective. They are also expensive and cumbersome. Many people who would benefit from them don’t use them. Experts believe that about a quarter of people who need them don’t use CPAP machines.
“An oral pill that targets the underlying neuromuscular drivers of airway collapse during sleep could help address this gap and broaden the range of effective options for patients who remain untreated today,” said Dr. Patrick John Strollo, a sleep medicine physician at the Univ. of Pittsburgh Medical Center.
Dr. Strollo ran a phase 3 clinical trial for AD109. It used 646 people with mild to severe sleep apnea in the U.S. and Canada who either couldn’t or wouldn’t use a CPAP machine. Half the people in the trial were taking a placebo, but no one knew which pill they had taken. They took the pill for 26 weeks.
By the end of the trial, 18 percent of people taking AD109 no longer had any symptoms. Another 42 percent has moved into a lower severity category. Side effects of the drug included dry mouth, nausea and insomnia.
The drug has received “FDA Fast Track designation” for treating sleep apnea. The Fast Track process is reserved for speeding the evaluation of drugs that treat serious conditions that don’t have other treatments. Because people don’t use or cannot afford CPAP machines, the need for medication is serious.
Hopefully, the FDA process goes well, and people are getting a better night’s sleep soon!

