From the Guidelines
Suboxone should be prescribed as part of a comprehensive treatment program for opioid use disorder, with a typical dosage ranging from 2-24 mg daily of buprenorphine component, and treatment duration varying from months to years or indefinitely, depending on individual patient needs and recovery progress.
Key Considerations for Suboxone Prescription
- Suboxone contains buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist) and is available as sublingual films or tablets that dissolve under the tongue 1.
- Treatment begins with an induction phase, requiring patients to be in mild to moderate withdrawal before starting (typically 12-24 hours after last opioid use) to avoid precipitated withdrawal, with an initial dose of 2-4 mg, and additional doses given as needed until withdrawal symptoms are controlled 1.
- Once stabilized, patients enter a maintenance phase with a single daily dose, typically 16 mg per day for most patients, though some may need up to 24 mg.
- Suboxone must be prescribed by healthcare providers with special DEA certification (X-waiver), though recent legislation has expanded prescribing capabilities.
Important Factors Influencing Suboxone Treatment
- The medication works by partially activating opioid receptors (reducing cravings and withdrawal) while the naloxone component prevents misuse by injection.
- Treatment duration varies from months to years or indefinitely, depending on individual patient needs and recovery progress.
- Suboxone is typically prescribed as part of a comprehensive treatment program that includes counseling and behavioral therapy.
- The dosage and treatment duration should be individualized based on patient response and medical history, with regular monitoring and adjustments as needed 1.
From the FDA Drug Label
2.1 Drug Addiction Treatment Act Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S. C 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. 2.2 Important Dosage and Administration Instructions Buprenorphine Sublingual Tablets are administered sublingually as a single daily dose. 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 2.4 Maintenance • Buprenorphine and Naloxone Sublingual Tablets are preferred for maintenance treatment
Suboxone Prescription and Use:
- Healthcare Provider Requirements: Healthcare providers must meet certain qualifying requirements and have a unique identification number to prescribe Suboxone for opioid dependence treatment 2.
- Administration: Suboxone is administered sublingually as a single daily dose.
- Induction: The first dose should be given when objective signs of moderate opioid withdrawal appear, considering the type of opioid dependence and time since last use.
- Maintenance: Buprenorphine and Naloxone Sublingual Tablets are preferred for maintenance treatment, with dosage adjustments made in increments/decrements of 2 mg or 4 mg buprenorphine 2.
- Key Considerations:
- Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.
- Patients dependent on methadone or other long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction.
From the Research
Suboxone Prescription and Usage
- Suboxone is a medication that contains buprenorphine, a partial opioid agonist, and naloxone, a non-selective opioid antagonist 3.
- Buprenorphine is one of the three medications approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder, along with methadone and naltrexone 4, 5, 6, 7.
- The naloxone in Suboxone has no additional effect when the drug is taken as instructed, but it is intended to prevent diversion in those who would attempt to inject the medication 3.
- Suboxone is used to suppress opioid withdrawal symptoms and attenuate the effects of other opioids, and it has been shown to be effective for the treatment of opioid use disorder 4, 5.
Treatment Goals and Strategies
- The pharmacotherapy of opioid use disorder has three overarching goals: to manage withdrawal, to reduce cravings, and to block the effects of nonmedical opioid use 6.
- Drug choice is only one component of the management plan for opioid use disorder; outcomes are improved with multicomponent and interprofessional strategies 6.
- Screening for opioid use disorder is indicated for certain populations, including pregnant women, and treatment with methadone or buprenorphine may be appropriate for these individuals 6.
Efficacy and Safety Considerations
- Evidence from numerous studies has shown buprenorphine to be effective for the treatment of opioid use disorder, although a majority of patients with opioid use disorder do not receive buprenorphine or any other medical treatment 5.
- Newer long-acting injectable formulations of buprenorphine may decrease the risk of diversion and improve adherence 5.
- Treatment with methadone and buprenorphine has the additional risk of diversion and misuse of medication, and naloxone may be used to reverse opioid overdose 4, 3.