After numerous high-profile stories of patients injuring themselves and others while taking Ambien, Lunesta and other sleep aid drugs, the risks are well-known. However, doctors continue to prescribe the drugs, and drug manufacturers continue to market and distribute them.
The U.S. Food and Drug Administration (FDA) announced a new boxed warning on some prescription insomnia drugs to better ensure patients are aware of the known drug risks. Ambien injury and related deaths are rare, though have occurred enough for the FDA to step in and issue an added warning.
Prescriptions for sleeping pills in the U.S. total more than 20 million. The FDA has warned of odd sleeping behavior since 2007, mostly from patients taking Ambien, the first of the insomnia drugs.
Patients on Ambien, Lunesta and Sonata have reported sleepwalking, sleep driving and engaging in other perilous activities like operating machinery. The black box warnings are now required for the following sleep drugs:
- Eszopiclone (Lunesta)
- Zaleplon (Sonata)
- Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist)
Joe Lyon is a highly-rated Cincinnati Drug Injury Attorney and Ohio product liability lawyer reviewing Ambien injury lawsuits and sleep drug accidents for plaintiffs nationwide.
Insomnia Drug Risks & Ambien Injury Lawsuits
Millions of Americans suffer from sleep issues and insomnia. Many wish to alleviate their problems with sleep aid drugs like Ambien, Sonata and Lunesta. But patients have not been properly warned by either doctors or drug companies about the risks these medications carry.
Even with new FDA boxed warnings, the risks still exist. A warning, after all, is not going to curtail what happens after the drug is ingested. But for liability reasons, drug companies feel the warning is a step in the right direction.
The Lyon Firm is committed to protecting consumers and holding drug companies responsible for the pharmaceuticals they market to the public. Sleep aid drugs are helpful, there is no doubt. But are they worth the risks of injury and accidents? This is a troubling question attorneys have had to ask in Ambien injury lawsuits and following sleep drug accidents.
Sleep Aid Side Effects & FDA Warnings
Sleep drug accidents can occur after the first dose or after a long period of treatment. Patients without any history of sleepwalking have been reported to have been active while sleeping, even while taking small doses of the Ambien, Sonata or Lunesta. It is critical to know of these risks before taking the insomnia drugs. Common side effects of Ambien and other Z-drugs include:
- Rapid heartbeat
- Impaired vision
- Slow breathing rates
- Allergic reactions
- Memory loss
- Disorientation
- Depression
- Anxiety
- Aggression
- Addiction
In addition to the new boxed warning, the FDA is requiring an added warning to avoid prescribing these medicines in patients who have experienced complex sleep behavior episodes. The association between insomnia drugs and complex sleep behaviors that can lead to injury and deaths is included in the label warning. Ambien injury lawsuits and consumer safety advocates argue the risks of such drugs are understated.
In the FDA Adverse Event Reporting System, there are 46 reports of non-fatal serious injuries, including accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-inflicted gunshot wounds and apparent suicide attempts. There have been 20 deaths reported from carbon monoxide poisoning, drowning, fatal falls, hypothermia, and motor vehicle accidents.
