Suboxone is a sublingual (SL) film dosage form containing a partial opioid agonist (buprenorphine) and an opioid antagonist (naloxone) for treating opioid dependence.1 It is a Schedule III Controlled Substance that was originally approved by the U.S. Food and Drug Administration (FDA) in August 2010. It should be used as part of a complete treatment plan that includes psychosocial support and counseling.
Prescribing Suboxone is limited under the Drug Addiction Treatment Act (DATA), which states that prescription use of Suboxone to manage opioid dependence is limited to health care providers who meet certain qualifying requirements, 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.2,3
Suboxone is administered sublingually or buccally as a single daily dose, which should not be cut, chewed, or swallowed. One film should be placed under the tongue close to the base on the left or right side and allowed to completely dissolve. For buccal administration, the film should be placed on the inside of the left or right cheek and allowed to completely dissolve.
To avoid precipitating withdrawal, induction with Suboxone should be undertaken when clear and objective withdrawal signs are evident.1,4 Whether the patient’s opioid dependence is with long-acting or short-acting drugs should be considered.
Initially, Suboxone should be given in divided doses. In patients dependent on short-acting opioids, start with up to 8 mg/2 mg (buprenorphine/naloxone) on Day 1 in divided doses. On Day 2, give a single dose of up to 16 mg/4 mg. For methadone or long-acting opioid dependence products, induction onto SL buprenorphine monotherapy is initially recommended for Days 1 and 2.
For maintenance treatment, the target Suboxone dosage is usually a single dose of 16 mg/4 mg. From Day 3 onward, doses should be progressively adjusted in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg to a level that suppresses withdrawal.
Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up. Patients should be monitored at least weekly for the first month. Once the patient has achieved a stable dosage and their assessment (eg, urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. There is no maximum recommended duration of maintenance treatment. Patients may need to remain on treatment indefinitely.
Buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTOD) for the risk evaluation and mitigation strategy (REMS) program is an FDA-required program designed to ensure informed risk-benefit decisions prior to beginning treatment and during treatment with BTOD drugs.5 This product’s REMS is to decrease the risk of abuse, addiction, misuse, overdose, and drug interactions leading to respiratory depression. Other adverse reactions include transaminitis, hypotension, hypersensitivity reactions, and central nervous system (CNS) depression.