EU committee backs adding sleep apnea trial data to Mounjaro label

The European Medicines Agency's human medicines committee recommended updating the Mounjaro label to include results from two trials of the drug in people with obstructive sleep apnea, according to the medicine's EU procedural record ^[1]. The opinion was issued on Dec. 12, 2024, and covers the parts of the label that describe what the drug is approved for, its side effects and its clinical pharmacology ^[1].

Under the filing, known as variation II/0027, sections 4.1, 4.8 and 5.1 of the Summary of Product Characteristics were updated, and the package leaflet was revised to match ^[1]. The record describes the supporting studies — listed as IBF-MC-GPI1 and IBF-MC-GPI2 — as multicenter, randomized, parallel-arm, double-blind, placebo-controlled trials of tirzepatide compared with placebo in adults with moderate-to-severe obstructive sleep apnea and obesity ^[1]. Tirzepatide is the active ingredient in Mounjaro ^[1].

The filing was logged under a category covering "addition of a new therapeutic indication or modification of an approved one" ^[1]. The procedural record does not state whether the outcome was a new, stand-alone EU indication for sleep apnea or an update to existing label text.

The results are not in this document

The record lists the scope of the change, the opinion date and the documents affected, but it does not reproduce the trial outcomes ^[1]. There are no figures for breathing pauses per hour, no weight-change numbers and no measures of daytime sleepiness in what was published here ^[1]. Those results have not been disclosed in this filing, so how large the benefit was, and in which patients, is not yet known from it.

Under the EU process, the committee opinion is followed by a European Commission decision, which is the step that makes a label change final. For this variation, that decision was issued on Feb. 14, 2025, about two months after the opinion ^[1].

Mounjaro is already authorized in the EU for type 2 diabetes and, since a December 2023 decision, for chronic weight management in adults with a body mass index of at least 30, or at least 27 with at least one weight-related condition ^[1]. A separate 2024 extension added six pre-filled pen strengths, from 2.5 mg to 15 mg per dose ^[1].

Separately, the same record shows that a periodic safety update for tirzepatide was issued on Dec. 12, 2024, the same day as the sleep apnea opinion, with a Commission decision on Feb. 14, 2025 ^[1]. The record points to scientific conclusions for that safety review without summarizing them, so what it concluded is not stated here ^[1].

Why it matters for patients

Label changes in Europe do not automatically change prescribing information in the United States, which is a separate document reviewed by a separate agency. No US label change tied to these two sleep apnea trials is described in this EU record ^[1].

For patients in Europe, the practical effect is that the sleep apnea data now sit inside the Mounjaro product information rather than only in published research. Because the results are not included in this filing, patients cannot yet compare effect sizes, duration of treatment or which severity of sleep apnea was studied from the record alone ^[1].

The record also does not address how or whether insurers, including US insurers, would cover tirzepatide for sleep apnea. Nothing in it changes dosing, and it does not add new strengths — the 2.5 mg to 15 mg pens were already authorized ^[1].

Obstructive sleep apnea and obesity often occur together, which is why the trials enrolled adults with both conditions ^[1]. That does not mean the data apply to people with sleep apnea who are not living with obesity; the record describes the study population as adults with moderate-to-severe obstructive sleep apnea and obesity ^[1].

What happens next

The sleep apnea label change is already final in the EU, with the Commission decision dated Feb. 14, 2025 ^[1]. The same procedural record shows later label work on Mounjaro: a variation, II/0038, based on the SUMMIT trial in people with heart failure with preserved ejection fraction and obesity, drew a committee opinion on Jan. 29, 2026, with no Commission decision listed ^[1]. A minor labelling change notification, N/0041, was issued on Feb. 26, 2025, with a decision on Jan. 22, 2026 ^[1]. No further steps specifically on sleep apnea labelling have been reported ^[1].