FDA Issues Boxed Warning for Popular Insomnia Drugs
Insomnia is a common complaint in hospitalized patients and elderly residents of nursing homes. The sleep condition is characterized by an imbalance of a person being able to fall asleep, stay asleep, or a general decline in sleep quality. Insomnia is a common condition that The Better Sleep Council’s studies say nearly 50 percent of patients report having. In the same survey, elderly patients, such as those that live in nursing homes, experience unique sleep disturbances, including:
- 21 percent reported new-onset insomnia
- 38 percent reported moderate or severe insomnia
- 38 percent reported sleep disturbances during hospitalization
While some health conditions and contributing factors to insomnia include severe morbidity, pain, obstructive sleep apnea, restless legs syndrome, and poor sleep hygiene, physicians are often too quick to pursue a pharmacologic route to help treat insomnia rather than looking to address an underlying problem. But drugs should only be considered if a patient has failed or refused nonpharmacologic therapy, according to studies evaluated by clinical resource, U.S. Pharmacist.
Also, some insomnia medications can disrupt a sleeping person’s brain quality and create side effects, including risky behaviors such as sleepwalking and engaging in dangerous activities while not fully awake.
List of Common Prescription Sleep Medicines with Serious Injury Risk Factors
In the spring of 2019, The Food and Drug Administration (FDA) released a statement that 66 sleep behaviors were documented to be triggered by specific prescription insomnia medication that caused serious injuries, including deaths, over the past 26 years. These behaviors appear to be more common than other prescription medicines used for sleep after a person takes:
- eszopiclone (Lunesta)
- zaleplon (Sonata)
- zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)
Related-medication injuries observed by the FDA’s 66 cases included:
- accidental overdoses
- exposure to extreme cold temperatures
- loss of limbs
- carbon monoxide poisoning
- motor vehicle collisions
- gunshot wounds
- suicide attempts
While these insomnia medications, also called sedative-hypnotics, have been approved and on the market for many years, the new FDA Boxed Warning statement says, “Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose.”
The statement continued, “As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.”
The FDA says health care professionals should:
- No longer prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines.
- Advise all patients the behaviors caused by these medicines have led to serious injuries or death.
- Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.
It is entirely reasonable for patients to trust the statements of their prescribing doctors and pharmacists, but it remains clear that medication errors do occur and injuries, sometimes deaths, can be the unfortunate result. In these cases, a doctor or health care professional must be proven negligent in prescribing medication or the wrong dosage. This can be a complicated process that requires assistance from a knowledgeable attorney.
Levin & Perconti Can Help If You Were Injured from a Medication
If you have experienced a medication-related injury or medical malpractice in Chicago or throughout Illinois, take action immediately. You may be entitled to compensation, and we are here to help. All consultations are free, and we work on a contingent fee basis, so there are no related costs for our services unless we successfully resolve your case.
Call us at 877-374-1417 or 312-332-2872 to speak with a lawyer. You may also contact us online to set up a case evaluation consultation with an experienced medical malpractice or if necessary, a wrongful death attorney.