Dear Colleague:

I want to alert you to an important development in the field of opioid use disorder treatment.

In December 2024, the FDA published a Federal Register notice to encourage manufacturers of buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs) to change their labels to empower clinicians to use their own judgment in determining the appropriate dose for patients, including doses higher than 24 mg/day. The manufacturers of Suboxone and Zubsolv then submitted updated labeling language, which the FDA approved in May 2025.

Until recently, the FDA-approved labeling for BTODs had stated “Doses higher than 24 mg daily have not been demonstrated to provide a clinical advantage,” and it referred to dosage of 16 mg as a “target dosage.” This was misinterpreted by some clinicians and insurers as establishing 16 or 24 mg/day as the maximum allowable dose of buprenorphine. The new language eliminates reference to a target dosage and clarifies that doses higher than 24 mg/day may be appropriate for some patients.

In recent years, prescribers, patients, and professional societies have expressed the concern that misperception that there was a maximum daily buprenorphine dose has limited access to this medication for patients who may benefit from higher doses, for instance because of a history taking high-potency synthetic opioids like fentanyl. The worry that higher doses may be inefficacious or unsafe has inhibited many providers from prescribing clinically sufficient doses and has led some insurance providers to limit coverage for BTODs and/or impose prior-authorization requirements that may delay a patient from getting their medication.

As you know, buprenorphine and other medications for opioid use disorder (MOUD) are critical tools for treating opioid use disorder and for addressing the overdose crisis that continues to claim more than 80,000 lives annually in the U.S. This change in buprenorphine labeling will encourage prescribers to use their own best judgment in determining the best dosages for their patients and encourage insurers to cover those dosages, thus enabling more patients to receive dosages of this medication that are appropriate to their individual therapeutic need.

For further information on the buprenorphine labeling changes and the FDA’s rationale, please see: https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-changes-labeling-transmucosal-buprenorphine-products-indicated-treat-opioid-use.

To review the newest labeling for the Suboxone and Zubsolv buprenorphine products, see: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.

Thank you.

-NIDA Public Inquiries Team