The U.S. Food and Drug Administration (FDA) has approved tirzepatide (Zepbound®) for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Tirzepatide may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity.
The approval was based on SURMOUNT-OSA phase 3 clinical trials, which were a multi-center, randomized, double-blind, parallel, placebo-master protocol comparing the efficacy and safety of tirzepatide (10 mg or 15 mg) to placebo in adults living with moderate-to-severe obstructive sleep apnea (OSA). Study 1 consisted of adults living with moderate-to-severe OSA and obesity who were unable or unwilling to use positive airway pressure (PAP) therapy, while Study 2 included adults living with moderate-to-severe OSA and obesity and planned to stay on PAP therapy during the duration of the trial. The trials randomized 469 participants across the U.S., Australia, Brazil, China, Czechia, Germany, Japan, Mexico and Taiwan in a 1:1 ratio to receive tirzepatide maximum tolerated dose of 10 mg or 15 mg or placebo. The primary objective of both studies was to demonstrate that tirzepatide is superior in change in apnea-hypopnea index (AHI) from baseline at 52 weeks as compared to placebo.
Tirzepatide was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with tirzepatide and five with placebo. In adults on PAP therapy, tirzepatide led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on tirzepatide and 50% of adults on tirzepatide with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.
In addition to improved OSA symptoms, adults on tirzepatide lost an average of 45 lbs (18%) of their body weight, while adults on tirzepatide with PAP therapy lost an average of 50 lbs (20%) of their body weight, compared to 4 lbs (2%) and 6 lbs (2%) on placebo, respectively. Tirzepatide is the first and only prescription medicine FDA-approved for moderate-to-severe obstructive sleep apnea in adults with obesity.