What is the recommended dosage and administration of Buprenorphine (Suboxone) naloxone sublingual for opioid addiction treatment?

From the Guidelines

Buprenorphine/naloxone (Suboxone) treatment for opioid addiction should be initiated with a sublingual dose of 2-4mg on day one, with possible increases to 4-8mg on the same day if needed, and a maintenance dose of 16mg daily, taken as a single daily dose or split into twice daily administration. The treatment typically begins with an induction phase, where patients should be in mild to moderate withdrawal before starting to avoid precipitated withdrawal 1. The sublingual film or tablet should be placed under the tongue until completely dissolved, without swallowing, talking, or drinking during dissolution for proper absorption.

Key Considerations

• The naloxone component is poorly absorbed via the sublingual route and is present only to prevent misuse of the medication by crushing and injecting the combined product 1.
• Brief treatment periods with rapid medication tapers are associated with high rates of relapse, and longer-term or maintenance treatment is generally indicated for patients with opioid dependence 1.
• Dose adjustments should be made in 2-4mg increments based on the patient's response, with the goal of suppressing withdrawal symptoms and cravings while minimizing side effects.
• Treatment duration is individualized, with many patients benefiting from long-term maintenance therapy, and discontinuation should involve gradual tapering under medical supervision to minimize withdrawal symptoms.

Administration and Monitoring

• Patients should be monitored closely during the induction phase and throughout treatment for signs of withdrawal, overdose, or other adverse effects.
• The maintenance dose can be adjusted based on patient response, and the goal is to find the lowest effective dose that suppresses withdrawal symptoms and cravings while minimizing side effects.
• Buprenorphine works as a partial opioid agonist, binding strongly to opioid receptors while producing limited euphoria, and the naloxone component deters misuse by causing withdrawal if injected 1.

From the FDA Drug Label

The recommended target dosage of Buprenorphine Sublingual Tablets is 16 mg as a single daily dose. 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. Buprenorphine Sublingual Tablets must be administered whole. Do not cut, chew, or swallow Buprenorphine Sublingual Tablets. Buprenorphine Sublingual Tablets should be placed under the tongue until it is dissolved

The recommended dosage of Buprenorphine (Suboxone) naloxone sublingual for opioid addiction treatment is:

• Induction: The first dose should be administered when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid.
• Maintenance: The recommended target dosage is 16 mg as a single daily dose, with a range of 4 mg to 24 mg buprenorphine per day.
• Administration: The tablets should be placed under the tongue until they are dissolved, and patients should not eat or drink anything until the tablet is completely dissolved. 2 2

From the Research

Buprenorphine Naloxone Sublingual for Opioid Addiction Treatment

• The recommended dosage and administration of Buprenorphine (Suboxone) naloxone sublingual for opioid addiction treatment is typically in the form of a sublingual tablet or film, with a common dosage being 4mg/1mg of buprenorphine/naloxone 3.
• The sublingual formulation is preferred to avoid the hepatic first-pass effect, and the combination with naloxone reduces the risk of diversion and abuse 4.
• Clinical trials have demonstrated that sublingual buprenorphine is effective in both maintenance therapy and detoxification of individuals addicted to opioids, with a long half-life making administration on a less than daily basis possible 5.
• The introduction of a sublingual formulation combining naloxone with buprenorphine further reduces the risk of diversion to illicit intravenous use, and has been made available in several countries for treating opioid addiction in the private office setting 5.

Dosage and Administration

• A study published in 2003 found that a daily dose of 16mg buprenorphine in combination with 4mg naloxone was effective in reducing opiate use and craving among opiate-addicted persons 6.
• Another study published in 2020 reported a case of naloxone-precipitated opioid withdrawal that was effectively treated with 4mg/1mg of sublingual buprenorphine/naloxone film 3.
• Higher doses of buprenorphine are associated with better retention rates, and the medication has a ceiling effect at the opioid receptor with regard to respiratory depression, making it a safer alternative to methadone 4.

Safety and Efficacy

• The safety and efficacy of buprenorphine and naloxone in combination have been well established, with studies showing that the combined treatment is safe and well tolerated, and reduces the use of opiates and the craving for opiates among opiate-addicted persons 6.
• The medication has been found to be effective in both maintenance therapy and detoxification, and has a long half-life making administration on a less than daily basis possible 5, 4.
• The combination with naloxone reduces the risk of diversion and abuse, and the sublingual formulation is preferred to avoid the hepatic first-pass effect 4.