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The Food and Drug Administration (FDA) on Friday approved Eli Lilly's weight-loss drug Zepbound as a treatment for moderate-to-severe sleep apnea and obesity.
It is the first medication approved to treat people with obstructive sleep apnea, said Sailly Seymor, director of FDA's division of pulmonology, allergy, and critical care. The FDA also confirmed that the weight-loss drug should be combined with a reduced-calorie diet and increased physical activity, for best results.
Sleep apnea is a sleep disorder causing breathing lapses during sleep. The body stops breathing many times while an individual is asleep, and this sleep disorder is considered serious and can't be left untreated.
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The symptoms include excessive daytime sleepiness, loud snoring, restless sleep, morning headaches, and trouble concentrating.
The FDA said that Zepbound's approval for moderate to severe obstructive sleep apnea in adults with obesity is based on two placebo studies that included 469 adults without type 2 diabetes. One group in the study received standard positive airway pressure (PAP) treatment, while the other group included individuals who did not use PAP machines.
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Participants in both groups were given a weekly dose of either 10 or 15 milligrams of Zepbound or a placebo over the course of one year.
Compared to the placebo group, those who took the drug experienced a significant reduction in episodes of stopped or shallow breathing.
Additionally, participants on Zepbound lost more weight than those in the placebo group after one year. According to the FDA, the improvement in their symptoms was likely linked to their weight loss.
Zepbound is a glucagon-like peptide-1 (GLP-1) drug designed to reduce appetite and food intake. Its active ingredient, tirzepatide, is marketed as Zepbound for weight loss and as Mounjaro for diabetes management.
Common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach discomfort, and pain. Other reported side effects include fatigue, allergic reactions, burping, hair loss, and gastroesophageal reflux disease (GERD).
Alongside Novo Nordisk's GLP-1 medications, Ozempic and Wegovy, these drugs have gained immense popularity for their effectiveness in managing weight loss and diabetes. Wegovy has also been approved to lower the risk of heart attack and stroke.
However, concerns have been raised by consumer advocates and policymakers about the high costs of GLP-1 medications. In response, many insurance providers, states, and employers have implemented limitations or restrictions on coverage for obesity treatments within this class of drugs.
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