Buprenorphine and methadone should not be withheld from patients struggling with opioid addiction if they’re also using benzodiazepines or other drugs that depress the central nervous system, the FDA says—even though the combined use of these drugs increases the risk of serious adverse effects.
“The dangers associated with failing to treat an opioid use disorder can outweigh the risks of co-prescribing MAT [medication-assisted treatment] and benzodiazepines,” says FDA Commissioner Scott Gottlieb, MD. “Instead, careful management of the patient and coordination of care is recommended.”
Gottlieb noted that addressing the opioid epidemic “is my highest public health priority” and that MAT—the use of medication combined with counseling and behavioral therapies—“is one of the major pillars of the federal response.”
“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,” Gottlieb added.
The agency is requiring updated labels for buprenorphine and methadone with detailed recommendations for minimizing the use of MAT drugs and benzodiazepines together.
Buprenorphine and methadone help people reduce or stop their abuse of opioids, including prescription pain medications and heroin. Methadone and buprenorphine have been shown to be effective in reducing the negative health effects and deaths associated with opioid addiction and dependency. Buprenorphine and methadone act on the same parts of the brain as the opioid that the patient is addicted to. The patient taking the medication as directed generally does not feel high, and withdrawal does not occur. Buprenorphine and methadone also help reduce cravings.
Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care professional’s direction or illicitly. The drugs are often prescribed to treat anxiety, insomnia, or other conditions. Although there are serious risks with combining these medicines, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs together, the FDA says. Instead, the combined use may continue outside the treatment setting, which could result in more severe outcomes.
When buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants, health care professionals should develop a treatment plan and take other steps:
- Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants when used as prescribed or used illicitly.
- Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT.
- Tapering the benzodiazepine or CNS depressant to discontinuation if possible.
- Verifying 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.
- Recognizing 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.
- Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment.
- Monitoring for illicit drug use, including urine or blood screening.
Sources: FDA; September 20, 2017; Gottlieb statement; September 20, 2017.