The U.S. Food and Drug Administration (FDA) is requiring a new boxed warning on some prescription insomnia medicines after reports of serious injuries and deaths resulting from complicated sleep behaviors.
The new warnings will be required for the following products:
- Lunesta (eszopiclone)
- Sonata (zaleplon)
- Ambien (zolpidem)
- Ambien CR (zolpidem)
- Edluar (zolpidem)
- Intermezzo (zolpidem)
- Zolpimist (zolpidem)
The boxed warning is the most prominent warning, which alerts patients that there’s a risk of serious injury or death.
According to the FDA, many patients who use these medications have suffered severe injuries and even death resulting from ‘complex sleep behaviors’ that include:
- Sleep Driving
- Engaging in activities while not fully awake
These incidents can happen after the first dose of these medicines, or it could happen after a longer period of treatment. In many cases, patients had no history of these sleep behaviors before taking this medication.
Doctors noted that these sleep behaviors occurred even at the lowest recommended doses, prompting the FDA to issue the latest warning.
What Prompted This Warning?
According to the FDA, a new safety review of 66 cases found that patients were engaged in activities while they weren’t fully awake. In all cases, the patients were taking the insomnia medicines, eszopiclone, zaleplon, or zolpidem. These are most commonly prescribed under the brand names, Lunesta, Sonata, and Ambien. Some of the non-fatal injuries included:
- Accidental overdoses
- Exposure to extreme cold temperatures
- Self-injuries, such as gunshot wounds
- Suicide attempts
In addition to these non-fatal incidents, the FDA was made aware of 20 deaths associated with the insomnia medicines. These fatalities were most commonly the result of:
- Carbon Monoxide poisoning
- Fatal falls
- Motor vehicle crashes
The FDA estimated that almost 30 million prescriptions of the three drugs were filled in the United States in 2018.
What To Do
The FDA is instructing patients to stop using these medications immediately if they’ve experienced any of the complex sleep behaviors listed above.
Patients were not properly warned about the risks associated with these medications. As a result, many people suffered unexpected side-effects and sudden injuries that have changed their lives.
If you or a loved one has suffered an injury or death while taking these medications, it’s vital to protect your rights as a patient. The experienced team of personal injury attorneys at Cellino & Barnes will fully investigate your situation, and help guide you through the process of potentially filing a claim.
We’ve helped victims of dangerous drugs get significant compensation from the pharmaceutical companies that failed to warn them about the risks associated with their medicines. Call us for a FREE consultation, and find out how a claim could help you and your family get justly compensated.
Cellino & Barnes (800) 888-8888