(RxWiki News) The US Food and Drug Administration (FDA) has added a boxed warning for certain sleep medications.
The boxed warning is the strongest type of warning the FDA gives. This particular warning addresses the possibility for serious injuries because of certain sleep behaviors.
These behaviors are referred to as complex sleep behavior and may include sleepwalking and sleep driving, among other activities. The FDA has listed this occurrence as rare. However, these behaviors have resulted in deaths, the agency noted.
This warning is geared more toward sleep medications known as the “Z-drugs.” These include eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist). The FDA noted that dangerous sleep behaviors seemed to be more common with these Z-drugs.
These medications are approved to treat insomnia, which is difficulty falling asleep or staying asleep.
The FDA noted that serious injuries and death from complex sleep behaviors have happened in the following situations:
- In those with or without a history of these types of behaviors
- Even at the lowest recommended doses
- Even after just one dose
Furthermore, these behaviors can happen if a Z-drug is taken with or without alcohol or other medications that work in the central nervous system, such as strong painkillers and anti-anxiety medications.
The FDA is also requiring the companies that make these medications to add a contraindication — in addition to the boxed warning — stating that those who have had an episode of complex sleep behavior with these types of medications should not take these drugs.
If you or a loved one has experienced an episode of complex sleep behavior (doing activities while you are not fully awake or not remembering certain activities), tell your health care provider. The FDA recommended that you stop taking these types of sleep medications if this occurs.
The agency also encouraged people to report any adverse events or side effects associated with their medications. You can do this by reporting online to www.fda.gov/MedWatch/report or calling 1-800-332-1088 to request a form to complete.
If you have any questions, talk to your doctor or pharmacist.
Written by Anyssa Garza, PharmD, BCMAS