Two drugs used to treat opioid abuse -- methadone and buprenorphine -- shouldn't be withheld from patients taking benzodiazepines and other CNS depressants, as the harms of not treating an opioid use disorder outweigh those posed by co-prescribing the drugs, the .
The agency is requiring this information to be added to the labels of these drugs, along with detailed recommendations for minimizing the risks of co-prescription with CNS depressants. The latter are often used to treat co-occurring mental health conditions like anxiety and insomnia.
FDA warned last year about prescribing opioids and benzodiazepines at the same time, which can lead to respiratory depression, coma, and death. But it exempted opioids used as medication-assisted treatment (MAT) from that warning, pending further review.
Label recommendations aimed at diminishing the risks of co-prescribing the medications will include having healthcare providers develop a treatment plan that monitors concomitant use, and carefully tapering benzodiazepines while considering other treatments for co-occurring mental health conditions.
FDA also strengthened the labeling for buprenorphine to emphasize that patients may require treatment indefinitely and should stay on it for as long as they benefit.
"We must do everything possible to address the staggering human toll caused by opioid use disorders, and ensuring patients receive proper treatment for both addiction and coexisting mental health conditions is a critical step in that effort," FDA Commissioner Scott Gottlieb, MD, .