Eli Lilly, a pharmaceutical company, announced on Friday that the Food and Drug Administration had extended the use of the weight-loss medication Zepbound to treat obstructive sleep apnea in obese individuals.
About 39 million individuals in the US suffer from the illness, and this decision makes it the first medication therapy for it.
The FDA has previously authorized Zepbound, which has the same active component as Lilly’s diabetic medication Mounjaro, to treat individuals who are obese or overweight.
More insurance companies that have been hesitant to cover the pricey weight reduction medications may decide to pay for the prescription as a result of the broader permission.
Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that promotes sleep health, stated in a statement that OSA [obstructive sleep apnea] is significantly more than “just snoring.”
Blockage of the upper airway during sleep results in obstructive sleep apnea, which stops airflow all night long. A person is frequently startled awake while gasping for air, which leads to fragmented, restless sleep. One of the main causes of sleep apnea is obesity, which can constrict the airway. It can cause diabetes, cardiac arrhythmias, heart failure, stroke, and brain damage if left untreated.
According to a research of over 4,000 participants that was presented at the annual conference of the American Academy of Neurology in April, those who suffer from sleep apnea may also be more susceptible to cognitive or memory issues.
Evidence that GLP-1 medications enhance general health in addition to weight reduction is supported by the approval. Novo Nordisk’s Wegovy was authorized by the FDA in March to lower the risk of heart disease. To find out if GLP-1s can help postpone renal disease, stop addiction, or prevent Alzheimer’s, further research is being done.
Whether Zepbound helps persons with sleep apnea via helping them lose weight or because its active component, tirzepatide, is doing anything else in the body is unknown. Two trials including obese men and women with moderate to severe sleep apnea served as the basis for the approval.
People who used Zepbound in Lilly’s sleep apnea study lost on average of 20% of their body weight.
People with sleep apnea typically see a reduction in symptoms when they lose weight, according to Dr. Susan Spratt, an endocrinologist and senior medical director for the Population Health Management Office at Duke Health in North Carolina.
“But as we’ve seen, it’s difficult to lose weight without taking medication,” Spratt stated.
Additional therapies for sleep apnea
Many sleep apnea sufferers remain undetected and untreated. Positive airway pressure (PAP) devices, which gently push air into the airway to prevent it from collapsing, are now used to treat obstructive sleep apnea. The most often recommended kind of PAP is continuous positive airway pressure, or CPAP.
According to Dr. Timothy Morgenthaler, a pulmonologist and sleep medicine specialist at the Mayo Clinic, CPAP devices are often affordable, operate rapidly, and have few side effects.
However, users have been irritated in recent years when Phillips Respironics, a major maker of CPAPs, recalled millions of its devices in 2021 after discovering that its noise-canceling foam might degrade and be ingested.
According to Morgenthaler, some people have trouble using CPAP machines and turn to less effective alternatives like surgery, which can be expensive, or oral devices.
According to him, this has made space for increased interest in medication alternatives like GLP-1s.
People may get rid of an uncomfortable machine with a weekly injection like Zepbound, or they could use it in conjunction with other treatments for better results.
“While tirzepatide may have other mechanisms that could be beneficial, weight loss alone can significantly reduce OSA severity for many patients,” Morgenthaler stated. Its high cost, adverse effects, and requirement for long-term treatment plans—which are still being researched—are obstacles, too.
How effective is Zepbound in treating sleep apnea?
Researchers at Lilly investigated if Zepbound was more effective than a placebo in lowering the average number of times an individual stopped breathing completely or partially during sleep, on an hourly basis. In the second investigation, PAP machines were utilized, but not in the first.
Those who were not using PAP devices saw an average decrease of 25 events per hour after 52 weeks, whereas those who were receiving a placebo experienced an average decrease of five occurrences per hour.
Zepbound resulted in an average decrease of 29 occurrences per hour in those who did use PAP equipment, whereas the placebo group saw an average reduction of six events per hour.
According to Lilly, 42% of people using Zepbound and 50% of those taking Zepbound in conjunction with PAP treatment had remission or decreased symptoms after a year.
Spratt called the approval a “incredible step forward,” but a head-to-head study would be necessary to ascertain whether Zepbound is better than PAP. She stated that gaining weight raises the risk of sleep apnea.
Other therapies are still required, according to Morgenthaler, who also noted that opening the airway by itself does not alleviate insomnia, which affects 30 to 40 percent of individuals with sleep apnea.
“We must understand that managing OSA involves more than just maintaining an open airway while we sleep,” he stated.
