The Food and Drug Administration on Friday approved the weight-loss drug Zepbound to treat obstructive sleep apnea. It is the first prescription medication approved to treat the common sleep disorder.
The drug's maker, Eli Lilly, announced that the agency authorized Zepbound for people with obesity and moderate to severe obstructive sleep apnea. Millions of Americans have the condition, and many of them also have obesity.
When people have obstructive sleep apnea, they struggle to breathe properly during sleep and can wake up gasping for air. If untreated, obstructive sleep apnea raises the risk for a range of health issues, including cardiovascular problems, diabetes, stroke and dementia.
In June, two studies found that people who took the drug saw a greater improvement in sleep apnea symptoms, including fewer interruptions in sleep, than those who took a placebo. Eli Lilly funded both studies.
Dr. Vivian Asare, associate medical director of the Yale Centers for Sleep Medicine, said the approval "offers up another option" for patients who have only limited treatments. Patients with the condition often use CPAP machines, which keep the airway open during sleep but can be cumbersome and unpleasant to wear through the night.
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Doctors also typically recommend that patients with both obesity and sleep apnea lose weight to ease their symptoms -- and the substance in Zepbound, a compound called tirzepatide, is extremely effective at helping people shed pounds. Tirzepatide is also the compound in the diabetes drug Mounjaro.
Even before the FDA approval, some doctors have been prescribing weight-loss drugs to people with sleep apnea.
The FDA's decision may place added pressure on insurance companies to cover obesity medications as some plans tighten restrictions on coverage.
"It would only drive up demand," said Dr. Melanie Jay, director of the NYU Langone Comprehensive Program on Obesity. So many patients have sought out tirzepatide that, until recently, there was a shortage of the medication.
The question now is whether Medicare will cover Zepbound for people with obstructive sleep apnea. Age raises the risk of developing the condition, Asare said. The disorder is more common in people older than 65 compared with the general population.
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Medicare currently does not cover medications that are solely prescribed for weight loss -- although the Biden administration has proposed changing that restriction. But the program may be able to cover an obesity medication that treats a secondary condition, such as obstructive sleep apnea.
Scientists are studying weight-loss drugs for a broad array of conditions, including kidney and liver disease and substance use disorder. In March, the FDA approved Wegovy, a weight-loss drug from Novo Nordisk, to reduce the risk of cardiovascular issues in people with obesity.