FDA Okays Benzodiazepines and Medication-Assisted Opioid Addiction Treatment

The FDA has issued a Drug Safety Communication on the use of benzodiazepines and opioid addiction medications. Benzodiazepines and other drugs that can depress the central nervous system do not have to be withheld from patients taking drugs such as buprenorphine or methadone for treatment of opioid addiction. However, careful medication management is needed to reduce the risks of serious side effects.

“The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks,” the FDA stated in its safety communication. “Careful medication management by health-care professionals can reduce these risks.”

The new information will be added to labeling for buprenorphine and methadone, along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together. Side effects of combining opioids and benzodiazepines include dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.

Many people who are addicted to or dependent on opioids also take benzodiazepines or other CNS depressants either licitly to treat anxiety and other conditions or illicitly. The FDA recommends that a patient’s treatment plan should include several actions or precautions if buprenorphine or methadone are used in combination with CNS depressants. These include:

• Educate MAT patients about the serious risks of combined use that can occur with CNS depressants.

• Develop strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT.

• Taper the benzodiazepine or CNS depressant to discontinuation if possible.

• Verify the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions.

• Recognize that patients may require MAT medications indefinitely and their use should continue for as long as patients are benefiting and their use contributes to the intended treatment goals.

• Coordinate care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment.

• Monitor for illicit drug use, including urine or blood screening.

This safety announcement is based on additional review of the use of these drugs together that caused the agency to update a previous communication. In late August 2016, the FDA had issued a strong warning against combining opioid medicines, including cough medicines, with benzodiazepines.