[ad_1]
The US Food and Drug Administration (FDA) adds a boxed warning to certain prescription medications for insomnia following reports of injuries and deaths resulting from sleepwalking, sleep driving, and death. Other activities that are not awake after taking these medications.
The new warnings will be necessary for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist), said the FDA in a communication on safety.
"We recognize that millions of Americans suffer from insomnia and rely on these medications to help them sleep better at night.Although these incidents are rare, they are serious and it is important that patients and health professionals are aware of the risks. " occur after the first dose of these sleeping pills or after a longer period of treatment, and may occur in patients with no history of these behaviors and even at the lowest recommended doses, "the FDA acting commissioner said in a statement , Ned Sharpless, MD, in a press release.
In addition to the framed warning, the agency will require the addition of a contraindication to the use of these drugs in patients who have experienced such an episode after taking them.
The FDA has reviewed 66 cases reported to the FDA's adverse event reporting system or found in the medical literature, in which patients engaging in activities while they were not fully awake , such as sleepwalking or driving while driving, resulting in serious injury or death after taking eszopiclone, zaleplon or zolpidem.
There were 46 cases of serious non-fatal injuries, including accidental overdoses, falls, burns, near drowning, exposure to extremely cold temperatures leading to limb loss or imminent death, and injuries such as gunshot wounds and alleged suicide attempts.
The 20 deaths reported were related to carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal collisions between a vehicle and its driver, and apparent suicide.
This is not the first time that the FDA reports safety issues for insomnia medications. In 2013, the agency reported an increased risk of depreciation of zolpidem the next morning and approved lower doses recommended for zolpidem. A year later, they noted a risk of weakening eszopiclone the next morning and reduced the recommended dose.
"We have been closely monitoring the safety profile of these drugs since their approval, when our ongoing safety surveillance recently revealed the risk of more serious injuries and deaths in patients taking these medications and who behaved differently. In complex sleep patterns, we determined that stronger measures were needed to inform the public, "said Janet Woodbad, MD, director of the FDA's Center for Drug Evaluation and Research.
"We will continue to monitor and evaluate the risks badociated with insomnia medications and to communicate with the public or consider other measures as appropriate," she added.
Health care professionals are encouraged to report the side effects of eszopiclone, zaleplon or zolpidem to MedWatch, the FDA's safety program and its adverse event reporting program.
For more information on Medscape Neurology, join us on Facebook and Twitter.
[ad_2]
Source link
