Yes, buprenorphine is FDA approved for pain management. Multiple formulations have been specifically approved for treating chronic pain, separate from the buprenorphine products approved for opioid use disorder. It is classified as a Schedule III controlled substance, meaning it has an accepted medical use and a lower potential for misuse than Schedule II opioids like oxycodone or fentanyl.
FDA-Approved Pain Formulations
Three buprenorphine products have received FDA approval specifically for pain:
- Buprenex (injectable): The first buprenorphine product available in the United States, a low-dose injectable (0.3 mg/mL) approved for pain treatment, typically used in clinical settings for acute pain.
- Butrans (transdermal patch): Approved in June 2010 for the management of moderate to severe chronic pain in patients who need continuous, around-the-clock opioid treatment. The patch delivers medication through the skin over several days.
- Belbuca (buccal film): A thin film applied to the inside of the cheek every 12 hours, approved for pain severe enough to require daily, long-term opioid treatment when other options are inadequate. It comes in seven strengths ranging from 75 to 900 micrograms.
These are distinct from products like Suboxone and Subutex, which are approved for opioid use disorder. Prescribing buprenorphine for chronic pain does not require a special waiver, unlike prescribing it for addiction treatment.
How It Works Differently Than Other Opioids
Buprenorphine is a partial agonist at the brain’s main opioid receptor. In practical terms, this means it activates the receptor enough to relieve pain but doesn’t produce the full effect that drugs like morphine or fentanyl do. This partial activation is the key to both its pain-relieving ability and its safety advantages.
Because it’s a partial agonist, buprenorphine has a built-in ceiling on certain dangerous effects. In a study comparing buprenorphine to fentanyl in healthy volunteers, fentanyl caused breathing suppression that worsened steadily with higher doses, eventually causing complete pauses in breathing. Buprenorphine, by contrast, slowed breathing to about 50% of normal and then leveled off, no matter how much higher the dose went. This ceiling effect on respiratory depression is one of the most important safety distinctions between buprenorphine and traditional opioids.
Buprenorphine products approved for pain don’t even have an associated morphine milligram equivalent (MME) conversion factor. Health agencies note that as a partial agonist, buprenorphine is “not expected to be associated with overdose risk in the same dose-dependent manner as doses for full agonist opioids.”
What the CDC Guidelines Say
The 2022 CDC Clinical Practice Guideline for Prescribing Opioids recognizes buprenorphine as a viable option for chronic pain, not just addiction. The guidelines note that patients on high-dose opioids who struggle to taper may benefit from transitioning to buprenorphine, citing its lower respiratory depression and overdose risk. In one specialty clinic study, nearly 19% of patients who couldn’t successfully taper their high-dose opioids were able to transition to sublingual buprenorphine instead.
The CDC goes further, stating that even without a diagnosis of opioid use disorder, switching to buprenorphine for pain “can be considered because of reduced risk for overdose with buprenorphine compared with risk associated with full agonist opioids.” This marks a notable shift toward viewing buprenorphine not just as an addiction medication but as a safer chronic pain option.
How Well It Controls Pain
A systematic review of ten trials involving 1,190 patients found sublingual buprenorphine to be effective as an analgesic. A broader review of 24 studies found that in 23 of them, buprenorphine provided pain relief comparable to morphine, fentanyl, and oxycodone. An international expert panel included buprenorphine among the six most commonly used strong opioids for chronic severe pain, particularly in older adults.
There’s also evidence that buprenorphine can help patients reduce their overall opioid use. In one study, 24% of patients decreased their total opioid consumption within six months of starting the transdermal patch, suggesting it may help people step down from higher doses of other opioids.
Common Side Effects
The side effects of buprenorphine are typical of opioid medications: constipation, dry mouth, nausea, vomiting, headache, dizziness, and drowsiness. These occur in at least 10% of patients.
For the transdermal patch specifically, skin irritation at the application site is the most frequently reported issue. In a large observational study, about 41% of patch users experienced some form of skin irritation, most commonly itching (61% of cases) or burning (19%). The good news is that these reactions were overwhelmingly mild to moderate, short-lasting, and confined to the area under the patch. Only about 9% of patients stopped treatment because of skin problems. Redness was the most common visible reaction, sometimes accompanied by small raised bumps.
Constipation was the second most common complaint after skin irritation (28% of patients), followed by nausea (17%).
Who Should Not Take It
Buprenorphine is contraindicated in anyone with a known allergy to the drug, as serious allergic reactions including anaphylaxis have been reported. Patients taking MAO inhibitors, a class of older antidepressants, should not use buprenorphine and need to wait at least 14 days after stopping an MAOI before starting it.
In the rare event that buprenorphine does cause significant breathing problems, the effects can be reversed with naloxone, though higher and more sustained doses of naloxone may be needed compared to reversing other opioids. In one study of healthy volunteers, a continuous infusion over 30 minutes was needed to achieve 80% reversal of buprenorphine’s respiratory effects.