December 13th, 2017
Say it [or] don’t spray it, cautioned the FDA’s Office of Prescription Drug Promotion in a recent warning letter to the marketers of Zolpimist, an oral spray approved by the agency for the short-term treatment of insomnia. In this case “it” meant the health risks associated with the drug, which range from drowsiness to a slowing down of the central nervous system. The FDA said these risks were altogether absent on a “product information” webpage and on promotional materials displayed at a trade show over the summer.
The FDA also found that the marketing materials made efficacy claims, such as stating that the spray “induces sleep three times faster than oral tablets,” for which there was no support.
In a joint letter to the heads of Amherst and Magna Pharmaceuticals, the FDA wrote:
These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Zolpimist.
Find more of our coverage on sleep products here.