Indication for Suboxone (Buprenorphine/Naloxone)

Primary Indication

The Centers for Disease Control and Prevention (CDC) recommends Suboxone as medication-assisted treatment combined with behavioral therapies to reduce illicit opioid use, prevent relapse, and improve patient outcomes in patients aged 16 years and older 1, 2
Suboxone is FDA-approved specifically for opioid use disorder, defined by DSM-5 criteria as a problematic pattern of opioid use causing clinically significant impairment or distress with at least two diagnostic criteria present within a year 1, 2

The American Academy of Pediatrics approves Suboxone for patients 16 years and older 3
Federal regulations generally prohibit methadone programs from admitting patients younger than 18 years, making buprenorphine particularly important for adolescent populations 3

The CDC recommends the buprenorphine/naloxone combination (Suboxone) over buprenorphine alone (Subutex) for most patients because the naloxone component reduces misuse potential 4

The CDC recommends Suboxone as medication-assisted treatment in combination with behavioral therapies, not as monotherapy, to reduce opioid misuse, increase retention in treatment, improve compliance after detoxification, and prevent relapse more effectively than behavioral therapy alone 1, 2
The therapeutic dose range for Suboxone is 8-16 mg daily, with a target dose of 16 mg daily for most patients 4

Buprenorphine maintenance therapy demonstrates clinical equivalence to methadone in retaining patients in treatment and reducing illicit opioid use, with moderate quality evidence supporting their superiority over non-medication approaches 1, 2
The CDC guidelines recommend buprenorphine or methadone as first-line medication-assisted treatment 1, 2

The American Academy of Pediatrics advocates for increasing access to medication-assisted treatment for adolescent and young adult patients with severe opioid use disorders, recommending that pediatricians either offer buprenorphine treatment directly or arrange referrals 3
For pregnant women with opioid use disorder, medication-assisted therapy with buprenorphine without naloxone or methadone is associated with improved maternal outcomes and should be offered 1, 2

Ongoing treatment requires regular urine drug testing, reassessment using DSM-5 criteria at follow-up visits, hepatitis C and HIV screening, and coordination with behavioral health providers 1, 2, 4

For pregnant patients on Suboxone, higher or more frequent dosing (2-4 times daily) may be required due to altered pharmacokinetics, according to the American College of Obstetricians and Gynecologists 5
The American College of Obstetricians and Gynecologists recommends continuing buprenorphine during pregnancy, but switching from buprenorphine/naloxone (Suboxone) to buprenorphine monotherapy (Subutex) if initiating treatment, as it results in less severe neonatal opioid withdrawal syndrome, shorter treatment duration, and shorter hospital stays compared to methadone 5

For chronic pain management in patients on Suboxone for OUD, consider switching to transdermal buprenorphine alone (without naloxone) as it bypasses first-pass hepatic metabolism and may provide superior analgesia, as suggested by the Infectious Diseases Society of America 6
When acute pain occurs, increase the buprenorphine dose first, as higher doses provide additional analgesia without the respiratory depression ceiling effect seen with full agonists, according to the Infectious Diseases Society of America 6

Screen all patients for depression using the two-question screen, and use the PHQ-9 for formal depression diagnosis, referring for psychiatric evaluation if score ≥10, as recommended by the Infectious Diseases Society of America 6
Screen for neurocognitive disorders before and during long-term opioid therapy, according to the Infectious Diseases Society of America 6