FDA adds boxed warn­ings to in­som­nia med­i­cines fol­low­ing in­juries, deaths

The FDA on Tues­day an­nounced the ad­di­tion of a boxed warn­ing to cer­tain pre­scrip­tion in­som­nia med­i­cines be­cause of var­i­ous be­hav­iors, in­clud­ing sleep­walk­ing and sleep dri­ving, that have led to in­juries and deaths.

The agency said the be­hav­iors ap­pear to be “more com­mon with es­zopi­clone (Lunes­ta), za­le­plon (Sonata), and zolpi­dem (Am­bi­en, Am­bi­en CR, Ed­lu­ar, In­ter­mez­zo, Zolpimist) than oth­er pre­scrip­tion med­i­cines used for sleep.”

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