Numerous Americans use prescription sleep meds such as Lunesta, Ambien, and Sonata to receive good shut-eye. Yet, the U.S. Food and Drug Administration on Tuesday slapped a difficult new warning label on this class of drugs, because of risks from daytime drowsiness the day when used.
The move was driven by 66 cases in which patients involved in something are labeled “complex sleep behaviors” after taking the insomnia medications.
In 20 cases, behaviors become deadly. Causes of death ranged from drowning, carbon monoxide poisoning, falls, hypothermia or automobile collisions (with the individual driving), an apparent suicide, the FDA said.
Forty-six other news included severe, but nonfatal wounds among those who took prescribed sleep meds and then participated in sleepwalking, sleep-driving and other activities while not entirely awake, the bureau declared in a statement.
While not even a single person was killed in those reports, injuries involved falls, burns, near-drowning, accidental overdoses, exposure to extreme cold temperatures leading to limb loss or near death, self-injuries like gunshot wounds, as well as apparent suicide attempts.
Consequently, the FDA is currently ordering new boxed warnings — the most prominent sort of label warning — on zaleplon (Sonata), eszopiclone (Lunesta), and zolpidem (Ambien, Ambien CR, Intermezzo, Edluar, and Zolpimist).
“This warning is likely to affect a lot of people, as millions take hypnotics — sleep aids — at least occasionally,” said Dr. Steven Feinsilver, who heads the Center for Sleep Medicine at Lenox Hill Hospital in New York City.
Another expert said the warning was required.
“These types of medications are well-known to trigger these [dangerous] events,” said Dr. Thomas Kilkenny, who directs sleep medication at Staten Island University Hospital in New York City.”In a susceptible person there could be no control over what happens once the patient goes to sleep.”
In interest to the boxed warning, the FDA requires the inclusion of a “contraindication” — advice to not use these medications for patients who have displayed complicated sleep behaviors after taking them.
“We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night,” FDA Acting Commissioner Dr. Ned Sharpless said in an agency news release.
However, “while these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk,” he added. “These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses.”
The relationship between this type of drugs and complicated sleep behaviors has been included in the labeling of those drugs. The current labeling changes should make the warning much more prominent, however, representing the possibility of severe harm and death, the FDA said.
For now, patients should stop taking these medications and contact their medical care provider immediately if they’ve engaged in actions while not entirely awake or if they don’t remember activities they have done while taking medicine.
The FDA offered additional information to individuals who take sleep helps:
- Do not use the medication in combination with any additional sleep medication, such as non-prescription sleep aids.
- Don’t consume alcohol while taking these medications, because of raised odds for unwanted side effects.
- In the case, you still feel tired after waking, bear in mind that any insomnia medication can lower attentiveness and interfere with driving or other complicated tasks.
For his part, Feinsilver stated the effectiveness of prescription sleep aids is “overrated” anyway.
Rather, he said, “most patients with chronic insomnia should be treated behaviorally. There often is no quick fix with sleeping pills.”
The boxed warnings have to list side effects such as sleepwalking and sleep-driving. However, such effects are rare; they can lead to severe death or injuries.
The New York Times: Drug Agency Requests For Strong Caution Labels On Prevalent Sleep Aids: National health regulators declared on Tuesday that they would need producers of sleeping pills like Ambien and related medications to post completely worded warnings in boxes on labels and individual guides. The Food and Drug Administration, in what is called a security statement, noted that the drugs’ side effects contained risky behaviors, like sleepwalking and sleep-driving, that may result in harm and even death. (Carey, 4/30)
The Wall Street Journal: FDA Orders’ Black-Box’ Advice For Sleep Aids: The FDA announced on Tuesday prescript insomnia pills which contain eszopiclone, zaleplon and zolpidem would need to show a black-box warning about possible dangers and a contraindication that they should not be taken by patients who have experienced complications like sleepwalking or driving while sleeping. (Armental, 4/30)
Bloomberg: Ambien, Lunesta Sleeping-Pill Side Effects? FDA Adds Warnings 46 reports of severe injuries were not deadly, such as burns, overdoses, loss of limbs from intense cold, and self-injuries from gunshot injuries. “These incidents can occur after the first dose of these sleep medicines period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses,” FDA Acting Commissioner Ned Sharpless said in a statement. “While these incidents are rare, they are serious and it’s important that patients and health-care professionals are aware of the risk.” (Cortez, 4/30)