Long-term sufferers of insomnia who have not found lasting relief from such sleep aids as Ambien or Sonta should consider researching Rozerem, the only medication of its type approved in the treatment of sleeplessness.

Rozerem (ramelteon) is the first of a new class of insomnia drugs: melatonin receptor agonists. These are similar to the naturally-produced sleep hormone melatonin, which your body needs for healthy sleep cycles. Rozerem, manufactured by Takeda Industries North America, was approved by the FDA in July 2005 for the treatment of delayed-onset insomnia. It emerged against a backdrop of other classes of drugs to treat the condition — and it has some important differences.

Insomnia was historically treated with barbiturates, which were extremely strong and frighteningly addictive. In the Sixties, the benzodiazepines appeared. These drugs (such as Halcion) helped treat insomnia with a much lower rate of serious side effects and addiction, but still had moderate side effects such as dizziness and a hangover effect. In the Nineties, there emerged a new class of non-benzodiazepine sleep aids, including Sonata and Lunesta, which have safely helped many people combat insomnia. Still, as they target several broad areas of the brain that are involved in sleep, they still have considerable side effects on memory and clarity.

In 2005, Rozerem was approved as a treatment for insomnia. It is said to have a different, more precise mechanism than other sleep aids, with an ability to target the “master clock” of the human body, affecting the sleep-wake cycle without unduly interfering with nearby brain functions.

Because it is in a different class than Lunesta and Ambien, Rozerem may be an effective treatment for patients who have not found lasting results on these medications. If you have not reconsidered your insomnia treatment since this important new class of drugs appeared in 2005, it is worth researching these new developments, as they may cure your insomnia more effectively, or do so with fewer side effects.

Side effects: Common side effects on this medication are dizziness, drowsiness, and daytime sleepiness. Sometimes people using this drug sleep-walk or perform other actions in their sleep. More serious side effects involve hormonal changes such as missed periods, nipple discharge, or difficulty becoming pregnant. It is important to tell your doctor immediately if you experience depressed or suicidal thoughts while taking this medication. Finally, be aware of any symptoms of a very serious allergic reaction to Rozerem such as a rash or swelling. Call your doctor immediately if this occurs.

Cautions and contra-indications: Rozerem is not suitable for patients with liver disease. You should not take it if you are also taking fluvoxamine, rifampin, or certain antifungal antibiotics. You should advise your doctor if you suffer from any breathing disorders such as sleep apnea or chronic obstructive pulmonary disease. You should also tell your doctor if you have a history of mental illness, depression, or suicidal thinking. And of these factors might mean that you cannot take Rozerem, or that you might have an adjusted dose. Rozerem is a pregnancy category C drug, so it may be harmful to an unborn baby, or in breast milk. Finally, Rozerem may affect hormonal levels in men and women, with possible effects to the desire and fertility. Talk with your doctor about your reproductive plans if you are considering Rozerem.

As with any drug, please consult your doctor before taking.

One of our favorite industry pundits is John Mack, author of Pharma Marketing News, Pharma Marketing Blog and The Pharma Blogosphere, and host of Pharma Marketing Talk. We recently asked him about his background, his readership and some current issues in pharma.

Cary: You started VirSci Pharma Marketing Network in 1997 and it has since blossomed in a number of directions — an e-mail discussion group, a newsletter, a Web site and a blog to name a few. How have you remained so passionate (and opinionated) about the pharma industry for so long?

John Mack: I was always interested in networking, people, and learning. The pharmaceutical industry is a challenge to keep up with and is more interesting to me than any other industry. After all, I started out studying biochemistry at Columbia University’s School of Physicians and Surgeons. So medicine and the mechanism of action of drugs have always been interesting topics. But I was impatient with the scientific method — I could never sequester myself in a laboratory. There’s just not enough people interaction.

I quit graduate school during the Vietnam War to work in an “underground” news service and became very much interested in journalism. As a matter of fact, I started writing newsletters when I was a teenager. So what I do now seems to combine everything I enjoy: science, technology, networking, newsletter writing, and education.

Cary: How would you characterize your readers? In what groups do they fall — Big Pharma reps, ad agencies, pharma vendors, etc? Have your audience and clients evolved over time?

John Mack: About 40 percent of the opt-in subscribers to the newsletter (Pharma Marketing News) work within life science companies (mostly brand manufacturers) and 40 percent work on the vendor/agency side. The rest are students, healthcare professionals, etc.

I don’t know much about the 80,000 or so monthly visitors to the Pharma Marketing Network Web site or the thousands who read Pharma Marketing Blog. I can say, however, that since starting the blog, many pharma people I meet at industry meetings know me and read the blog.

Cary: In all your years of sharing your opinions on the industry, is there one newsletter article, blog post or comment you’ve made that has caused the biggest controversy? If so, which one?

John Mack: There are a few. The most read and commented blog post was “Rozerem Ads Dis Lincoln, Show Beaver.” A couple that caused a lot of controversy were “The Girl from Google” and “Banned from CafePharma!”

Cary: With DTC advertising everywhere, more and more patients have decided what medications they need before they visit their doctor. Do you think this has led to overmedication? If so, what do you think should be done about it? And what other problems do you see with DTC today?

John Mack: I don’t know if DTC is the main cause of overmedication, which I think is definitely a problem in the U.S. Advertising must play a big role in driving sales; otherwise, there wouldn’t be so much of it. But the problem with DTC and advertising in general is that it is really not educational, despite claims otherwise by PhRMA and the drug industry. What really irks me is stupid DTC campaigns that waste money and clutter the airwaves — money and bandwidth that could have been used to do effective education. The Rozerem ads are the poster boys of this deficiency in DTC.

Cary: We started eDrugSearch.com to help people find Canadian drugs online without having to deal with the spam and questionable players that, unfortunately, currently inundate the marketplace. As an expert in Internet marketing as well as pharma, what do you think of our business model? Since we’re a new business, do you have any advice for us?

John Mack: Stay under the radar of Big Pharma! They will try and shut you down if you become too big. Build up your relationship with users and give them a voice through your site to demonstrate that their concerns are mainstream.

Great advice. Thanks, John!

Takeda Pharmaceuticals North American, Inc. has been cited by the FDA for airing unapproved reminder ads for its sleep aid medication Rozerem. Here’s an excerpt from the citation letter, courtesy of PharmaLive:

While reminder ads are exempt from the requirement to disclose information relating to risks and effectiveness, for the reasons set forth below, we have determined that your TV ad is not an appropriate reminder ad. As such, the failure of the TV ad to disclose the drug’s indication, the failure to include information relating to the major side effects, and the failure to make adequate provision for dissemination of the FDA-approved labeling … thus misbrands Rozerem …

Although the TV ad does not state the drug product’s indication or recommended dose, the statements and images suggest that Rozerem is indicated for children. Specifically, the TV ad includes the following statements and corresponding visuals: “Rozerem would like to remind you that it’s back to school season.” (visuals include chalk board, school books, school bus, laptops, school-aged children with backpacks) … The combination of these statements (“Back to School”) and images of school-aged children and school-related objects suggest that Rozerem is indicated for and can be safely used in the pediatric population…

The presentation in the TV ad is especially concerning given that the PI for Rozerem includes the following Precaution regarding pediatric use: “Safety and effectiveness of ROZEREM in pediatric patients have not been established. Further study is needed prior to determining that this product may be used safely in pre-pubescent and pubescent patients.”…

Takeda’s explanation for the ad targeting kiddies? According to The Pharma Blogosphere Blog, the company stated:

Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question.

That’s accountability for you.

And Takeda’s punishment? A strongly worded letter.