From the Guidelines
The starting dose of Suboxone (buprenorphine/naloxone) for a patient with opioid use disorder is 2-4 mg, repeated at 2-hour intervals, if well tolerated, until resolution of withdrawal symptoms, with a typical total dose of 4-8 mg on the first day. This approach is based on the most recent and highest quality study available, which emphasizes the importance of initiating buprenorphine after mild withdrawal is present to avoid precipitated withdrawal 1.
Key Considerations
- Patients should discontinue all opioids the night before initiation, depending on the duration of action, to minimize the risk of acute opioid withdrawal 1.
- The dose can be titrated upward over the first few days, with regular monitoring of withdrawal symptoms, cravings, and side effects.
- It is essential to reevaluate the patient on day 2 and increase the dose if needed, with the total dose given on day 2 becoming the daily dose.
Administration and Monitoring
- Suboxone should be administered as a sublingual film or tablet, placed under the tongue until fully dissolved, typically 5-10 minutes.
- Patients should be instructed not to eat, drink, or smoke during this time to ensure proper absorption.
- Regular monitoring during induction is crucial, with dose adjustments made based on the patient's response to treatment.
Long-term Treatment
- Treatment with Suboxone is typically long-term, often lasting months to years, as longer durations of therapy are associated with better outcomes in opioid use disorder.
- Clinicians should be aware of the potential for protracted withdrawal symptoms, such as dysphoria, irritability, and insomnia, which may occur months after opioid elimination, and be prepared to address these symptoms with adjuvant agents and supportive care 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.
The starting dose of Suboxone (buprenorphine/naloxone) for a patient with opioid use disorder is 2 mg to 4 mg on the initial day of treatment, given in increments if preferred, and administered when objective and clear signs of moderate opioid withdrawal appear. 2
From the Research
Starting Dose of Suboxone (Buprenorphine/Naloxone)
- The starting dose of Suboxone (buprenorphine/naloxone) for a patient with opioid use disorder is not explicitly stated in the provided studies as a single, universally accepted dose.
- However, according to 3, most patients can be treated initially with and maintained on a daily buprenorphine/naloxone dose of 4:1-24:6 mg.
- A study published in 4 reported a successful rapid transition to buprenorphine/naloxone using a dose of 16 mg/4 mg, which suggests that this dose may be effective in certain situations.
- Another study, 5, used a buprenorphine dose of 2-24 mg (mean 16) in patients switched from buprenorphine alone to buprenorphine/naloxone, with satisfactory management of withdrawal symptoms reported by the majority of patients.
Dosing Considerations
- The dosing schedule for buprenorphine/naloxone may vary depending on the individual patient's needs and response to treatment 3.
- It is recommended to start with a low dose and gradually increase as needed, rather than starting with a high dose and risking adverse effects 6.
- The presence of naloxone in the buprenorphine/naloxone combination does not appear to influence the pharmacokinetics of buprenorphine 6.