Federal regulators indicate that Amherst Pharmaceuticals and Magna Pharmaceuticals, the makers of Zolpimist oral spray, are putting out misleading information that downplays the potential side effects of the insomnia drug and overstates the effectiveness.
The FDA sent a warning letter (PDF) to the companies on November 14, over statements made on websites and at exhibits that fail to list potential adverse effects, and make inaccurate claims that suggest the drug outperforms oral tablets like Ambien, which uses the same active ingredient, zolpidem.
The agency approved Zolpimist (zolpidem tartrate) oral spray in 1992, for the short-term relief of insomnia. However, the label carries warnings about the potential risks of hypersensitivity, central nervous system (CNS) depressant effects, next-day impairment, abnormal behavioral changes, potential problems for those suffering from depression or respiratory depression, and the risk of withdrawal effects.
In recent marketing statements, the FDA indicates that many of those serious risks were downplayed or missing entirely on some webpages and exhibit panels.
“The webpage and the exhibit panels include claims and/or representations about the efficacy of Zolpimist. Both the webpage and the exhibit panels, however, fail to communicate any risk information,” the warning letter states. “By omitting the risks associated with Zolpimist, the webpage and the exhibit panels fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety. This misleading presentation is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”
The FDA also found instances where the company dramatically overstated the drug’s benefits in marketing materials.
The webpage includes claims that it outperforms Ambien, acts three times as fast and that food does not reduce the drug’s efficacy. The exhibit panels also claim that using it can help avoid nightly dependency.
“The suggestions that Zolpimist will ‘outperform’ or induce sleep three times faster than zolpidem oral tablets, or that patients treated with Zolpimist require less frequent treatment compared to those on the tablet formulation…are misleading,” the letter indicates. “FDA is not aware of data to support the claims that Zolpimist is clinically superior in efficacy to other oral zolpidem products or that patients treated with Zolpimist require less frequent treatment compared to those on the tablet formulation.”
The agency also said it has no data suggesting Zolpimist can induce sleep as fast as the manufacturer claims (within 10 minutes) and says that the FDA-approved label for Zolpimist specifically states that food can indeed slow the effects of Zolpimist if it is taken with, or immediately after, a meal.
The letter calls on the manufacturers to respond either with proof of their allegations or with a plan to address what the FDA considers false and misleading advertising. Failure to do so could result in regulatory actions such as seizure or injunction, the agency warned.
Sleeping Pill Safety Concerns
The warning comes about two years after the Institute for Safe Medication Practices (ISMP) raised questions about the safety of Ambien and similar sleeping drugs, suggesting that clinical trials used to obtain FDA approval for the medications do not actually match how the drugs are used.
The ISMP found that consumers often use the medications far longer than is recommended, and they are often used by those with mental illness or taking other psychoactive drugs.
According to the ISMP report, the U.S. Centers for Disease Control and Prevention (CDC) found that Ambien and its generic zolpidem equivalents were the drug most linked with emergency room visits, according to adverse event data received by the FDA. According to the report, there are an estimated 10,2112 emergency department visits each year linked to Ambien use, with 25% of those requiring the person be hospitalized.
New warnings for Ambien, Zolpimist and other zolidem products were approved by the FDA in May 2013, indicating that users should not drive or engage in other activities requiring mental alertness the next day after taking the medication.
In May 2013, the FDA approved a new warning label for sleeping pills like Ambien and sprays like Zolpimist. The warnings recommended lower doses to reduce the risk of experiencing lingering side effects the following morning after taking the drug.