What is the recommended dosing for Suboxone (buprenorphine and naloxone) in adults?

From the Guidelines

Suboxone, a combination of buprenorphine and naloxone, is typically dosed in adults for opioid use disorder treatment, with the maintenance phase usually stabilizing at 16 mg daily (range 4-24 mg), taken as a single daily dose or split into twice daily dosing. The initial induction phase begins with 2-4 mg sublingually on day one, with potential additional doses up to a total of 8 mg on the first day, as patients should be in mild to moderate withdrawal before starting to avoid precipitated withdrawal 1. During days 2-7, the dose is adjusted upward as needed, typically to 12-16 mg daily, based on withdrawal symptoms and cravings.

Key Considerations

• The maximum FDA-approved dose is 24 mg daily, though most patients achieve optimal results with 16 mg or less.
• Suboxone should be placed under the tongue until completely dissolved (typically 5-10 minutes), and patients should avoid eating, drinking, or smoking for 30 minutes before and during administration to ensure proper absorption.
• Dose adjustments may be needed for patients with hepatic impairment, and treatment duration is individualized, often lasting months to years or indefinitely for some patients.
• The buprenorphine component provides opioid effects with a ceiling that limits respiratory depression risk, while naloxone deters misuse by causing withdrawal if injected 1.

Clinical Evidence

Studies have shown that buprenorphine has a high binding affinity for the μ-opioid receptor, which diminishes the ability of other more potent full agonist opioids to dislodge it from the receptor, making it a beneficial property in the treatment of opioid use disorder 1. Additionally, buprenorphine has been found to provide comparable pain relief with fewer adverse events compared to full opioid agonists such as transdermal fentanyl and morphine for chronic pain 1.

From the FDA Drug Label

2.3 Induction Prior to induction, consideration should be given to the type of opioid dependence (i.e., long- or short-acting opioid products), the time since last opioid use, and the degree or level of opioid dependence Patients Dependent on Heroin or Other Short-acting Opioid Products At treatment initiation, the first dose of Buprenorphine Sublingual Tablets should be administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period In a one-month study, patients received 8 mg of Buprenorphine Sublingual Tablets on Day 1 and 16 mg Buprenorphine Sublingual Tablets on Day 2. From Day 3 onward, patients received either Buprenorphine Sublingual Film or Buprenorphine Sublingual Tablets at the same buprenorphine dose as Day 2 based on their assigned treatment

1. 4 Maintenance • Buprenorphine and Naloxone Sublingual Tablets are preferred for maintenance treatment • Where Buprenorphine Sublingual Tablets is used in maintenance in patients who cannot tolerate the presence of naloxone, the dosage of Buprenorphine Sublingual Tablets should be progressively adjusted in increments / decrements of 2 mg or 4 mg buprenorphine to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms • After treatment induction and stabilization, the maintenance dose of Buprenorphine Sublingual Tablets is generally in the range of 4 mg to 24 mg buprenorphine per day depending on the individual patient. The recommended target dosage of Buprenorphine Sublingual Tablets is 16 mg as a single daily dose. Dosages higher than 24 mg have not been demonstrated to provide any clinical advantage

The adult dosing for Suboxone is as follows:

• Induction: The first dose should be administered when objective signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred.
• Maintenance: The maintenance dose is generally in the range of 4 mg to 24 mg buprenorphine per day, with a recommended target dosage of 16 mg as a single daily dose. 2

From the Research

Suboxone Adult Dosing

• The provided studies do not directly address Suboxone adult dosing, but rather focus on patient preferences, treatment outcomes, and barriers to accessing medications for opioid use disorder.
• A study from 2014 3 compared treatment retention among patients randomized to buprenorphine/naloxone (Suboxone) versus methadone, finding that higher medication doses were associated with lower opiate use and better treatment retention.
• The study found that the treatment completion rate was higher for methadone (74%) compared to buprenorphine/naloxone (46%), but that higher doses of buprenorphine/naloxone (30-32 mg/day) were associated with improved treatment completion rates.
• Another study from 2017 4 provides recommendations for buprenorphine and methadone therapy in opioid use disorder, emphasizing the importance of individualized treatment choices based on clinical efficacy, safety, patient preference, and other factors.
• However, none of the provided studies specifically address Suboxone adult dosing guidelines or recommendations.
• A study from 2022 5 highlights the importance of patient autonomy and flexibility in opioid use disorder treatment, which may inform dosing decisions, but does not provide specific guidance on Suboxone adult dosing.
• Studies from 2010 6 and 2025 7 discuss drug interactions and barriers to accessing medications for opioid use disorder, but do not provide information on Suboxone adult dosing.