Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Drug Safety Podcasts

FDA Drug Safety Podcasts Home
          Drugs
          Drug Safety and Availability
          FDA Drug Safety Podcasts
          FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risksFDA Drug Safety Podcasts FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On September 20, 2017, based on additional review, the FDA advised that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system. 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. Careful medication management by health care professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (or MAT) drugs and benzodiazepines together. Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care professional’s direction or illicitly. 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 unlikely to stop them from using these drugs together.

Buprenorphine and methadone help people reduce or stop their abuse of opioids, including prescription pain medicines 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. These medications are often used in combination with counseling and behavioral therapies, and patients can be treated with them indefinitely. Buprenorphine and methadone work by acting 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.

**Health care professionals** should take several actions and precautions and develop a treatment plan when a MAT drug, such as buprenorphine or methadone, is used in combination with benzodiazepines or other CNS depressants.

In August 2016, we issued a Drug Safety Communication warning about the combined use of opioid-containing medicines with benzodiazepines or other CNS depressants. Review of a published study and other drug use data showed that buprenorphine and benzodiazepines have frequently been prescribed for the same patient, by the same prescriber dispensed by the same pharmacy. An epidemiological study from Sweden found that receiving MAT with benzodiazepines or other CNS depressants appears to increase the risk of death. Based on this, information about the interaction with benzodiazepines and other CNS depressants and the risks of slowed or difficult breathing and death will be added to the *Boxed Warning* for methadone products. Expanded guidance will be added to the *Warnings and Precautions* section on management of patients in methadone treatment who also take CNS depressants. For buprenorphine products, the *Warnings and Precautions* section will be expanded and revised to provide more detailed guidance on managing patients in buprenorphine treatment who are also taking CNS depressants.

Side effects involving buprenorphine, methadone, or other medicines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Thank you for listening.

Related Information

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
	FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

                                                                                  Content current as of:
      01/19/2022FDA Drug Safety Podcasts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop