Why did the FDA assign a black box warning to Ambien?

The FDA is the Food and Drug Administration. They are a federal agency responsible for the safety and monitoring of prescription medications.

Recently a new pattern of illnesses was identified called “complex sleep behaviors”. The complex sleep behaviors were linked to medications such as Ambien, Lunesta, and Sonata. People taking these medications and accidents while driving had bizarre psychiatric behavior, and some committed suicide.

At least 66 case reports were submitted to the FDA voluntarily over 26 years. Based on the information they found, it was estimated there could be hundreds or even thousands more cases with similar side effect profiles.

A black box warning was issued so that doctors, pharmacists, and patients are aware that there is a real risk of using these medications. These medications are typically used on a short-term basis as needed. They were not intended by many factors to be used chronically.

Your doctor can still prescribe medications, however, it is likely they will offer you alternative medications or try to get you off of these medications in the future especially if more cases are identified.

You can read more from the FDA’s website below and be sure to talk with your doctor about any concerns you may have.

 

References:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia

https://www.livescience.com/65372-ambien-new-fda-warning.html

 

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If you think you may have a medical emergency, call 911 immediately. Dr. Emran and Simple Health Radio do not recommend or endorse any specific tests, physicians, products, procedures, opinions, consults, or any other information that may be mentioned on this website or radio podcast.

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