Advertisement: Ambien 'Beach' Submitted to FDA in April 2002

Expert Comments:

"This is a drug with a high abuse potential. The advert promotes its effectiveness (which is accurate) but underplays that it is not a drug for routine use. It states, "people who abuse sleep aids may develop addiction" but this misleads the viewer who may feel well they don¹t misuse these pills. In fact, anyone may develop addition and this is often the case."
- Michael Wilkes, M.D., Ph.D., University of California, Davis

"The ad for Ambien states that: "Patients who abuse prescription sleeping pills may become dependent." The product label clearly states that anyone can become dependent, regardless of abuse history."
- Barbara Mintzes, University of British Columbia

"We found the major statement in this ad inadequate in communicating the risk of dependence to consumers. The ad did not clearly communicate that the drug is a controlled substance. The ad stated: "Patients who abuse prescription drugs may become dependent." This is, of course, true as a general statement. But, consumers need a statement about the dependency risks of zolpidem [Ambien]. Consumers can unexpectedly become dependent to controlled substances if not properly informed."
- Larry Sasich, Pharm. D., Public Citizen Health Research Group

"The ad may not adequately convey that FDA approval is for short term use only (7-10 days). The ad states that Ambien is "most often" indicated for short term use."
- Richard Kravitz, M.D., University of California, Davis