Bloomberg reports the Food and Drug Administration will now require a boxed warning on certain prescription sleeping drugs, including Ambien (zolpidem), Lunesta (eszopiclone), and Sonata (zaleplon), advising patients about the risk of serious side effects that can lead to death. The article explains that the agency “said it had found 66 examples of patients who took the drugs and engaged in dangerous activities such as sleepwalking or driving while not fully awake, including 20 deaths linked to carbon monoxide poisoning, drowning, fatal falls, hypothermia, car crashes and apparent suicide.” FDA Acting Commissioner Ned Sharpless said in a statement, “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.”

CNN reports the boxed warning will notify patients of “possible serious or life-threatening behaviors that may result from taking these drugs.” The FDA said, “Patients usually did not remember these events. The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.”

From the news release of the American Association for Justice.