FDA Policy/General

Zolpimist Web Page, Exhibit Panels Misbranded: FDA

The CDER Office of Prescription Drug Promotion (OPDP) says that an Amherst Pharmaceuticals Web page for Zolpimist (zolpidem tartrate) oral spray and Magna Pharmaceuticals’ convention exhibit panels for Zolpimist make false or misleading claims and/or representations about the risks associated with the drug’s efficacy. An 11/14 Warning Letter says the promotional materials also were not submitted at the time of initial dissemination or publication. “These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Zolpimist,” the letter says.

Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. It is contraindicated in patients with a known hypersensitivity to zolpidem. The drug’s labeling contains Warning and Precautions about central nervous system depressant effects and next-day impairment, the need to evaluate for co-morbid diagnoses, severe anaphylactic and anaphylactoid reactions, abnormal thinking and behavioral changes, use in patents with depression, respiratory depression, and withdrawal effects.

OPDP says the Web page and exhibit panels include claims or representations about Zolpimist efficacy. However, they both fail to communicate any risk information. It says the misleading presentation is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.

In addition, OPDP says, the Web page and exhibit panels contain claims that misleadingly suggest that Zolpimist is clinically superior in efficacy to other zolpidem products in treating insomnia because of its formulation and mode of action. The letter says the promotional material claims are not supported by any references and that FDA is not aware of any data to support the claims that the drug is clinically superior in efficacy to other oral zolpidem products (Ambien) or that patients treated with Zolpimist require less frequent treatment compared to those on the tablet formulation.

The companies were told to immediately stop misbranding Zolpimist and/or stop introducing the misbranded drug into interstate commerce. They were told to respond with a plan for discontinuing use of violative materials or stopping Zolpimist distribution. They also are to submit a plan to disseminate truthful, non-misleading and complete corrective messages about the issues discussed in the letter to the audience(s) that received the violative promotional materials.

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