You’ve probably seen ads on TV and in print for several new drugs to treat insomnia. FDA-approved drugs for this condition include AMBIEN (Sanofi-Aventis), LUNESTA (Sepracor), SONATA (King Pharmaceuticals), and ROZEREM (Takeda).

As the competition for market share heats up, you can expect to see these brands push the DTC advertising “envelope” the same way that erectile dysfunction (ED) drug ads did. What I am talking about is:

Indication Bloat — the tendency to inflate the estimated number of people that suffer from the drug’s indicated condition. I have written on this topic before, using ED as a case study (see “Indication Bloat – The Next DTC Issue“). Like ED, insomnia may be difficult to define and most ads I’ve seen hardly mention insomnia at all. Instead, the ads use phrases like “Trouble Sleeping?” or “Tossing & Turning?” Here’s some numbers you might hear:

An estimated 126 million adult Americans experience at least one insomnia symptom a few nights a week, according to the National Sleep Foundation, a group which receives some of its funding from drug companies. Only about a third of sufferers are actually diagnosed with insomnia, and a small fraction of those are treated with prescription medication. (“Ad war looms in crowded sleep aid market”; Boston Globe, July 19, 2005)

Lack of Disease Awareness Education — Indication bloat is aided and abetted by a lack of any educational content in DTC advertising. After all, the more consumers are educated, the less likely that they will fall victim to the indication bloat ploy. While the web sites for these “sleep aids” offer decent disease education (you might need to use the “site map” function to find this stuff), the TV ads don’t have much meat in that department. There’s also no mention of other, non-drug, treatments for insomnia.

Glossing Over Important Side Effects — Most of the “sleep aid” medications, like all drugs, have side effects. How fair is the balance in the ads for these drugs when the side effects are mentioned in a relaxing tone of voice over images of a relaxed sleeping beauty?

Making Claims That Are Not Supported in the Drug’s Labeling — Some physicians are miffed at LUNESTA ads that claim the drug is approved for long-term use whereas the label does not specifically say that. According to an article in the August 18, 2005 issue of the Boston Globe: “[The FDA approved label] does not mention how long the pills can safely be taken. The FDA did not require the label to specify that the drug is for ”short-term” use, as it has for other prescription sleep aids on the market.”

PhRMA Code Litmus Test
One of PhRMA’s new DTC guidelines states: “DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.” This would effectively put an end to reminder ads (see “Reminder Ads – Pharma’s Dodo?“).

I am keeping unofficial tabs on compliance with these guidelines and have already mentioned a case where a drug company may be in violation (see “After School Cialis Ads“).

Yesterday, I saw reminder ad for LUNESTA on TV even though Sepracor announced nearly two months ago that it will abide by PhRMA’s voluntary guidelines. I guess this is another case of running ads that were already purchased, which I find a poor excuse.

What Does Trust Mean?
Pharma companies want to improve their image with consumers and have a trusting relationship with consumers. I would think that the most effective way to build trust would be to carry through on promises made. If you promise not to run reminder ads, for example, then don’t run them. Duh!