New Buprenorphine for OUD Labels Clarify Higher Doses Appropriate for Some Patients

As of May 2025, Suboxone and Zubsolv, transmucosal buprenorphine products for the treatment of opioid use disorder (OUD), have modified their labels to clarify that there is no maximum daily dosage.  

The label update follows the Food and Drug Administration’s (FDA) December 2024 recommendation that transmucosal buprenorphine product labels be updated to address misperceptions of a daily maximum dose of 16 or 24 milligrams (mg). Instead, practitioners should take a patient-centered approach and adjust dosages based on the patient’s therapeutic needs and responses. For some patients, doses higher than 24 mg may be appropriate.  

Labels for Suboxone and Zubsolv have been changed to the following: 

Suboxone: After treatment induction to the recommended dose of 16 mg/4 mg buprenorphine/naloxone per day, dosing should be further adjusted based on the individual patient and clinical response. The maintenance dose of SUBOXONE sublingual film is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day. Dosages higher than 24 mg/6 mg daily have not been investigated in randomized clinical trials but may be appropriate for some patients. 

Read the updated label here. 

Zubsolv: After treatment induction to the recommended dose of 11.4 mg/2.9 mg buprenorphine/naloxone per day, dosing should be further adjusted based on the individual patient and clinical response. The maintenance dose of ZUBSOLV is generally in the range of 2.9 mg/0.71 mg buprenorphine/naloxone to 17.2 mg/4.2 mg buprenorphine/naloxone per day. Dosages higher than 17.2 mg/4.2 mg buprenorphine/naloxone daily have not been investigated in randomized clinical trials but may be appropriate for some patients. 

Read the updated label here.  

This label clarification aligns with "ASAM’s Clinical Considerations: Buprenorphine Treatment of Opioid Use Disorder for Individuals Using High-potency Synthetic Opioids." 

The document outlines considerations for changes to the clinical practice of treatment of OUD with buprenorphine for individuals using high-potency synthetic opioids, such as fentanyl. It notes that some patients, including those with high opioid tolerance, may require buprenorphine doses higher than 24 mg. Importantly, individualized strategies for buprenorphine initiation may be needed.