Good Night Forever? –
April 29, 2019 – The new black box warning—the strictest label used by the FDA to denote potentially life-threatening side effects—will apply to three drugs commonly used for insomnia and sold under various brand names. They are eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, among other names). In addition to the warning, people will also be told to stop or avoid using these drugs if they’ve ever experienced these symptoms. “We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk,” Ned Sharpless, the current acting director of the FDA, said in a statement.
The FDA’s decision, the agency said, was motivated by its recent review of 66 case reports about strange behaviors linked these drugs, including some that had been reported to the FDA directly. More than 40 reports of non-fatal…
