Dec. 23, 2024 -- The FDA has approved the first prescription drug, Zepbound, for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Studies have shown that when combined with a low-calorie diet and increased exercise, Zepbound improves OSA symptoms by reducing body weight, particularly in those with weight-related health issues.
OSA is a breathing disorder where the upper airway becomes partially or fully blocked during sleep, causing shallow breathing or brief pauses in breathing (apnea), often followed by gasping, snorting, or waking suddenly. OSA can reduce oxygen flow, disrupt heart rhythms, and harm overall health. Common signs such as snoring, tiredness, daytime sleepiness, and disrupted sleep often go unnoticed. OSA is more common in people with obesity, as excess neck weight can press down on the airway.
Zepbound, the brand name for the generic drug tirzepatide, is an injectable medication that aims to treat OSA by causing weight loss. It works by activating special proteins — glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors — in the intestine, which help suppress appetite and reduce eating. This dual-receptor activation may offer more effective weight management than the drugs targeting only the GLP-1 receptor.
The approval was granted to Eli Lilly and Company, the drug’s maker, based on two clinical trials involving 469 adults without type 2 diabetes. One study included patients using positive airway pressure (PAP), the standard treatment for moderate to severe OSA, while the other included people not using PAP. In both studies, participants were randomly given either Zepbound or a placebo weekly for 52 weeks. Results showed that Zepbound significantly reduced breathing interruptions (apnea and hypopnea) during sleep compared to the placebo. More patients treated with Zepbound saw their symptoms improve or resolve, along with notable weight loss, which likely contributed to improvement in their OSA symptoms.
The FDA statement details the side effects of Zepbound, which include nausea, vomiting, belching, acid reflux, stomach pain, diarrhea, constipation, injection site reactions, tiredness, allergic reactions (mostly fever and rash), and hair loss.
Patients should inform their doctor before starting Zepbound if they have a family history of thyroid cancer, serious allergies, or any issues with their pancreas, gallbladder, kidneys, or eyes, especially if they have diabetes, according to the FDA and Lilly. They should also mention any history of depression or suicidal thoughts. If they are on insulin or other diabetes medications, their doctor may need to adjust their doses. Patients should also inform their doctor about any upcoming surgeries or procedures. Women using birth control pills are advised to discuss their dosage with their doctor, as Zepbound may make them less effective. Their doctor may suggest using another form of birth control for four weeks after starting Zepbound and after each increase in the dose.
