The F.D.A. has approved Zepbound as the first and only prescription medication for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.
Eli Lilly stated that Zepbound, containing tirzepatide, must be used alongside a reduced-calorie diet and increased physical activity to improve OSA symptoms and support weight management.
Zepbound is available in doses of 10 mg and 15 mg, starting at 2.5 mg and increasing by 2.5 mg every four weeks until reaching the maximum tolerated dose (MTD).
Patients who tolerated 15 mg continued at that dose, while those unable to tolerate it remained on 10 mg, as determined in the trials.
The SURMOUNT-OSA phase 3 clinical trials showed Zepbound significantly reduced apnea-hypopnea index (AHI) scores compared to placebo.
Patients not on PAP therapy experienced an average of 25 fewer breathing interruptions per hour with Zepbound compared to five with placebo, while those on PAP therapy saw 29 fewer interruptions per hour compared to six with placebo.
After one year, 42% of patients on Zepbound alone and 50% combining Zepbound with PAP therapy had remission or mild, non-symptomatic OSA, compared to 16% and 14% with placebo, respectively.
Zepbound also resulted in significant weight loss, with patients losing an average of 45 lbs (18% of body weight) on Zepbound and 50 lbs (20%) with Zepbound and PAP therapy.
Patients on placebo lost only 4 lbs (2%) without PAP therapy and 6 lbs (2%) with PAP therapy.
OSA is a serious condition where upper airway collapses during sleep, leading to breathing interruptions, fatigue, and higher risks for cardiovascular disease and diabetes.
Traditional treatments like CPAP machines and PAP therapy can be difficult to use, making Zepbound a valuable alternative for addressing OSA symptoms and its underlying cause, obesity.
Zepbound’s active ingredient, tirzepatide, is a dual-activating GIP and GLP-1 medication that reduces appetite and food intake.
Potential risks of Zepbound include thyroid tumors, pancreatitis, kidney problems, and gallbladder issues, with symptoms like neck lumps, hoarseness, or breathing problems requiring immediate medical attention.
Patients with a history of medullary thyroid carcinoma (MTC), Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or severe allergic reactions to tirzepatide should not use Zepbound.
Common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, tiredness, injection site reactions, belching, and hair loss.
Patients must monitor for low blood sugar when combining Zepbound with insulin or sulfonylureas, and they should report any changes in vision or mood-related symptoms like depression.
Zepbound is not recommended for children or to be used alongside other GLP-1 receptor agonists, and pregnant or breastfeeding women should consult their healthcare providers.
This approval builds on Zepbound’s prior F.D.A. indication for weight loss in adults with obesity or overweight-related conditions, granted in November 2023.
Zepbound offers a groundbreaking approach to managing OSA symptoms and weight loss, addressing both conditions simultaneously.
Patients and healthcare providers are encouraged to have discussions about Zepbound’s suitability based on individual medical histories and health needs.
For further details on Zepbound’s indications, safety profile, and usage, visit zepbound.lilly.com or contact Eli Lilly.
Take-Home Points:
First-of-its-Kind Treatment: Zepbound is the first and only prescription medication approved for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity.
Dual Benefits: Zepbound addresses both OSA symptoms and significant weight loss, reducing breathing interruptions and helping patients shed 18-20% of body weight.
Proven Effectiveness: Clinical trials demonstrated that Zepbound reduced 25 to 29 breathing interruptions per hour, and up to 50% of patients no longer showed symptoms of OSA after one year.
Accessible Dosing: Available in 10 mg and 15 mg doses, with a starting dose of 2.5 mg, adjusted every four weeks to the maximum tolerated dose.
Alternative to CPAP Machines: Zepbound offers a non-invasive option for patients struggling with the inconvenience of traditional OSA treatments like CPAP machines.
Safety Considerations: Zepbound carries risks such as thyroid tumors, pancreatitis, and kidney issues, and is not recommended for individuals with certain medical histories (e.g., MTC, MEN 2).
Comprehensive Treatment Approach: Zepbound must be used with a reduced-calorie diet and increased physical activity for optimal results.
Patient Suitability: Zepbound is not intended for children or pregnant women and should not be combined with other GLP-1 receptor agonists.
Groundbreaking Impact: This approval marks a significant step forward in managing the interconnected challenges of sleep apnea and obesity, offering hope for millions of patients.
