Zepbound (tirzepatide) is notably more affordable when purchased in vials rather than auto-injection pens. Already widely utilized as an effective treatment for obesity, this medication has gained significant attention for its potential to address related health conditions.
Key Highlights:
- The U.S. Food and Drug Administration (FDA) recently approved Zepbound as the first prescription drug specifically for adults managing both moderate-to-severe obstructive sleep apnea (OSA) and obesity.
- Clinical trials revealed that individuals taking Zepbound experienced an average weight loss of 45 pounds, along with a 50% reduction in breathing interruptions during sleep.
- Despite its benefits, Zepbound is not intended to replace continuous positive airway pressure (CPAP) therapy, which remains the standard treatment for OSA.
By combining its proven efficacy in weight management with its new indication for OSA, Zepbound offers a valuable option for patients struggling with these intertwined health challenges.
FDA Approval of Zepbound: A Landmark Development for Obstructive Sleep Apnea and Obesity
The U.S. Food and Drug Administration (FDA) has approved Zepbound (tirzepatide) as the first prescription medication specifically targeting moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. This marks a groundbreaking step forward in the treatment of individuals managing both significant sleep-related breathing disorders and excess weight.
“This is the first drug treatment for obstructive sleep apnea, and so that’s exciting,” said Atul Malhotra, MD, a professor of medicine and sleep medicine specialist at UC San Diego Health. “It provides a good opportunity to help the care of many people with obstructive sleep apnea and obesity.” Dr. Malhotra was the lead author of clinical trials pivotal to Zepbound’s approval.
The American Academy of Sleep Medicine (AASM) echoed this sentiment in a public statement, calling the approval “a positive development for patients and clinicians, who now have another treatment option for this sleep disorder.”
How Zepbound Works
Zepbound belongs to a class of medications known as GLP-1 receptor agonists, originally designed to treat type 2 diabetes. The drug mimics metabolic hormones that regulate blood sugar levels, increase insulin sensitivity, and slow digestion. These effects collectively reduce appetite, helping individuals feel fuller after eating and consume less overall.
Clinical data shows Zepbound’s effectiveness in addressing obesity extends beyond weight loss. Studies reveal improvements in cholesterol levels, blood sugar control, and blood pressure among patients using the drug.
While the precise mechanism by which Zepbound alleviates OSA remains under investigation, weight loss plays a likely role. “Obesity is a major factor that increases the risk of OSA,” explained Nathan Walker, MD, assistant professor of sleep medicine at the University of North Carolina.
Dr. Walker detailed several mechanisms linking obesity to OSA. “For one, obesity causes direct compression of the upper airway with weight around the neck,” he noted. Additionally, abdominal obesity can reduce lung capacity, which diminishes the structural support of the upper airway, making it prone to collapse during sleep.
However, not all cases of OSA are directly tied to obesity. Factors such as jaw structure and airway anatomy may also contribute, Walker added, underscoring the complexity of the condition.
Zepbound’s Effectiveness in Treating Obstructive Sleep Apnea
Zepbound’s approval for treating OSA stems from promising results in the SURMOUNT-OSA clinical trials, which enrolled 469 adults diagnosed with moderate-to-severe OSA and obesity. Participants were assigned to receive either Zepbound or a placebo over 52 weeks. Two trials were conducted: one involving patients not using CPAP therapy, and the other including individuals who combined CPAP with Zepbound.
Key findings from the trials demonstrated significant reductions in apnea (complete cessation of breathing) and hypopnea (shallow breathing) events per hour, as measured by the apnea-hypopnea index (AHI).
Key outcomes included:
- Among participants combining CPAP with Zepbound, 50% achieved either complete remission or a reduction to mild OSA, compared to just 14% in the placebo group.
- For those using Zepbound without CPAP, 42% achieved similar results, while only 16% of the placebo group did.
- On average, patients taking Zepbound lost 45 pounds (18% of their body weight), compared to 4 pounds (2%) for the placebo group.
These findings highlight Zepbound’s potential to address the dual challenges of obesity and OSA. However, the trials did not include individuals without obesity, leaving questions about its efficacy for non-obese OSA patients unanswered.
“This question has not been tested in clinical trials. It would not be recommended to use GLP-1s outside the indications approved by the FDA,” cautioned Ali El Solh, MD, MPH, a professor of medicine at the State University of New York in Buffalo. Dr. El Solh led a recent review on GLP-1 medications and their impact on obesity-related OSA.
Implications for CPAP Therapy
While Zepbound offers an alternative treatment avenue, experts emphasize it is not a replacement for continuous positive airway pressure (CPAP) therapy, the gold standard for OSA management.
“In the studies on tirzepatide and OSA, patients had a roughly 50% reduction in the severity of their OSA on average,” said Walker. “This would significantly reduce the severity but not necessarily eliminate it. Patients should not throw out their CPAP machines just yet.”
Malhotra agreed, reiterating the importance of CPAP as first-line therapy. “It’s always been the case that we want to treat both sleep apnea and obesity,” he said, emphasizing that diet and exercise remain essential components of treatment.
Zepbound and similar GLP-1 receptor agonists, however, offer a more effective tool for achieving sustained weight loss, complementing existing approaches. “I think it’s important that people understand this approval doesn’t mean it’s the end of CPAP,” Malhotra added.
Safety and Potential Risks
Like many medications, Zepbound comes with potential side effects. In clinical trials, the most common issues included gastrointestinal symptoms such as nausea, vomiting, diarrhea, and constipation. These were typically mild to moderate in severity.
Additional side effects observed in trials for obesity and diabetes included fatigue, allergic reactions, burping, hair loss, and gastroesophageal reflux disease (GERD).
One concerning finding from preclinical studies was the development of thyroid C-cell tumors in rats treated with Zepbound. Although it remains unclear whether the drug poses a similar risk to humans, patients with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 are advised against using the medication.
“These drugs are considered relatively new agents, and thus the long-term safety of these medications is yet to be established,” said El Solh.
Accessibility and Cost Challenges
Despite its clinical benefits, Zepbound’s high cost may limit access for many individuals. GLP-1 receptor agonists are widely recognized as “game changers” in managing obesity and related conditions, but affordability remains a significant barrier.
Insurance coverage for Zepbound as a treatment for OSA is still uncertain. The drug’s price varies depending on the formulation: a 28-day supply of self-injecting pens costs $1,059.87, while monthly doses in vial form are priced at $399 and $549 for 2.5 and 5 milligrams, respectively, through the LillyDirect program.
For those without comprehensive insurance coverage, these costs may render the medication inaccessible, despite its potential to transform the lives of patients with obesity and OSA.
A Step Forward
Zepbound’s approval as the first FDA-approved medication for moderate-to-severe OSA in obese adults represents a major advancement in the field of sleep medicine. By addressing both sleep apnea and weight loss simultaneously, the drug provides a new option for patients who have long relied on CPAP therapy alone.
While questions remain regarding its long-term safety and applicability to non-obese individuals, Zepbound underscores the potential of innovative treatments to improve quality of life for those facing complex health challenges. With further research and increased accessibility, this medication could play a vital role in the future of sleep and obesity management.