Ambien, Other Sleep Drugs Will Carry ‘Black Box’ Warning

On Tuesday, the FDA announced that it would be requiring prescription sleep aid drugs including Ambien to bear a new black box warning of risks associated with the medication.

These risks range from sleep walking to sleep driving, to drowning, and other possible tragic events.

The drugs that will be affected by this move are those made of eszopiclon and zolpidem. These medications are sold under a range of brand names, like Ambien, Lunestsa, Edluar, Intermezzo, and Zolpomist.

The FDA’s black box warning is the strongest warning available. In addition to the back box warning, the FDA will require the manufacturers of Ambien and other sleep aids to offer guides to help patients better understand the risks of using the medications.

The injuries addressed by the new FDA black box warning are those that patients suffer after engaging in activities that they do not remember, according to reports.

The FDA says that 66 individuals reported injuries while using the drugs that included sleep driving, self-inflicted gunshot wounds, burns, and suicide attempts.

Reportedly, there were 46 reports of people suffering injuries that weren’t deadly, and 20 instances resulted in deaths from causes like carbon monoxide poisoning, drowning, fatal falling, and car crashes.

These drugs have been on the market for years, and while the FDA has expressed concern over this type of problem before, the problem may be more severe than previously thought.

Bloomberg reports “the cases are an example of how previously unknown serious side effects can emerge for medicines that have been on the market for years and used by millions of people.”

These injuries reportedly occurred in patients who both did and did not have a history of sleep-related behaviors. They apparently occurred in patients who had taken the lowest recommended doses of the drugs, or even took only a single dose.

Additionally, the FDA notes that the use of alcohol or other depressants did not cause the dangerous behaviors — use of the sleep aids alone reportedly could result in these behaviors.

This most recent move by the FDA to warn patients of the possible risks of injury while taking Ambien and other sleep aid medications isn’t the first move in this direction.

In 2007, the FDA asked makers of sedative-hypnotic drugs to advertise more serious warnings for the risks associated with their medications. These risks included behaviors like sleep driving.

At the time, these drug makers were also required develop drug use guidelines for patients, and to reach out to medical providers to notify them of the new warnings.

The instances of injury and death during use of sleep aids are rare, but the FDA stresses that they are serious. Experts note that instances of these types of behaviors, and injuries resulting from them may not have been reported, so the issue may be bigger than what is suggested by the 66 reported cases.

FDA acting Commissioner Ned Sharpless said that “we recognize that million of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk.”

Read More Lawsuit & Settlement News:

Best Buy Class Action Says AppleCare+ Charged Without Consent

How Do I Know If My Knee Replacement Is Loose?

Nestle Class Action Says ‘No GMO’ Labels Are Misleading

What Are the Neocate Dangers?