Sleep drugs to carry Boxed Warning on serious side effects
The US Food and Drug Administration has issued a new Boxed Warning for certain common prescription insomnia medicines, due to “several reports of rare, but serious injuries and deaths.”
The products affected are Lunesta (eszopiclone), sold by Japan’s Dainippon Sumitomo Pharma (TYO: 4506), Sonata (zaleplon), and various brands of zolpidem, including Ambien, from Sanofi (Euronext: SAN) and Zolpimist, from AYTU BioScience (Nasdaq: AYTU).
These belong to the class of sedative-hypnotics and have been approved and on the market for many years.
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