Buprenorphine and methadone (drugs used for medication-assisted treatment [MAT]) should not be withheld from patients taking CNS depressants, including benzodiazepines, according to a new safety communication from the Food and Drug Administration (FDA). 

While the combined administration of these agents increases the risk of serious adverse effects (ie, severe respiratory depression, death), “the dangers associated with failing to treat an opioid use disorder can outweigh the risks of co-prescribing MAT and benzodiazepines,” said FDA Commissioner Scott Gottlieb, MD in a press release. A review of several published studies showed that the evidence did not support dose limitations or arbitrary caps of buprenorphine or methadone as a strategy to address benzodiazepine or other CNS depressant use in MAT-treated patients. 

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When working on a treatment plan for patients using MAT in combination with benzodiazepines or other CNS depressants, the FDA recommends the following: 

  • Educate patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly
  • 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 consider other treatment options for these conditions
  • Recognize patients may require MAT medications indefinitely and use should continue for as long as patients are benefiting and it 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

In addition, manufacturers will be required to add these new precautions and recommendations to the drug labeling for buprenorphine and methadone products. 

For more information visit FDA.gov