Eli Lilly and Co. received approval from the FDA for Zepbound (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound 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.

OSA is a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to pauses in breathing (apnea) or shallow breathing (hypopnea) and a potential decrease in oxygen saturation and/or waking from sleep. 

This approval was based on results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Zepbound (10 mg or 15 mg) for the treatment of moderate-to-severe OSA in adults with obesity, with and without positive airway pressure (PAP) therapy over the course of a year. Zepbound 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 Zepbound and five with placebo. In adults on PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.