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FDA Gives Ambien and Other Prescription Sleep Drugs a Black Box Warning

On Behalf of | Jun 28, 2019 | Uncategorized

In April 2019, the FDA placed a Black Box Warning, the highest possible warning the FDA can mandate, on the updated labels of prescription sleep drugs, including Ambien and Lunesta. These new warnings will alert patients of risks including sleep driving, drowning and suicide attempts. Here, the Baltimore pharmaceutical liability attorneys at The Law Offices of Peter Angelos detail the events that led to the FDA Black Box Warnings as well as your rights as a victim.

Insomnia Drugs are Prescribed to Millions of Individuals

Insomnia is a common condition that is characterized by the inability to fall or stay asleep frequently. It is estimated that one in four Americans suffer from insomnia to some degree and that many turn to prescription sleep drugs such as Ambien, Lunesta, Sonata, Edluar and more. Millions of Americans take sleeping pills every year to treat or manage their insomnia or other sleep-related conditions.

Twenty Fatalities are Linked to Prescription Sleeping Drugs

According to the FDA’s adverse reporting system, 62 individuals reported incidences of sleep driving, burns, suicide attempts and self-inflicted gunshot wounds while taking sleep drugs between 1992 and 2018. Twenty of these incidences resulted in fatalities, and many of the individuals reported that they did not have any recollection of the events and what led up to their occurrence. It is also assumed that these numbers represent a mere fraction of the actual number of patients who have suffered from these safety concerns, according to Michael Carome, the director of health research at Public Citizen in Washington, D.C.

Sleeping pill manufacturers that produce insomnia medications eszopiclone and zolpidem, which are sold under the brand names Sonata, Lunesta, Ambien and others, will now be required to show a Black Box Warning that details the risks of using sedative drugs including sleepwalking and other sleep-related activities that can result in serious injury or death.

The FDA Has Tracked the Events Surrounding Sleep Drugs for Over a Decade

While the FDA has not issued a Black Box Warning for major sleep drug manufacturers until this year, the organization has tracked the adverse reactions related to sleep drugs for more than ten years. In 2007, the FDA urged manufacturers of sleep drugs to include more direct language outlining the risks of sleep-hypnotic side effects, including sleep driving. During this time, major drug manufacturers were required to send letters to healthcare providers informing them of the risks surrounding the drugs. They were also required to develop drug guides for patient use.

Recent FDA Warning on Ambien Side Effects

In March 2024, the FDA issued a health advisory regarding side effects from zolpidem and other so-called “z-drugs” for treating insomnia. The agency warns of the risk of “complex sleep behaviors” as a side effect. This refers to patients sleepwalking, driving a car, cooking food and other potentially dangerous activities while still asleep. Some patients have reported taking medications while under the influence of a z-drug and accidentally overdosing. The FDA recommends discussing the risks and benefits of z-drugs before taking them, carefully reading the Patient Medication Guide that comes with your prescription, taking the prescribed dose only and not mixing your medication with other sleep drugs or alcohol.

Contact a Pharmaceutical Liability Attorney at The Law Offices of Peter Angelos

With the growing prevalence of taking sleeping pills to treat insomnia comes a greater risk of patients sleepwalking, sleep driving, drowning and unknowingly inflicting harm to themselves and others due to the sleep-hypnotic effects of many prescription sleep drugs. If you or a loved one ever experienced a dangerous sleep-hypnotic episode that resulted in injury or death as an outcome of taking sleep drugs, consult an experienced pharmaceutical liability attorney at The Law Offices of Peter Angelos today to discuss if your experience constitutes a case.