Ad drive promotes sleeping pill

Rozerem claims fewer side effects


Chicago -- Hoping to help Americans snooze while also putting to rest controversies dogging the crowded group of prescription sleeping pills, a drugmaker has kicked off a nearly $100 million consumer ad campaign for its insomnia pill.

Takeda Pharmaceuticals North America Inc. launched yesterday an ad campaign directed at consumers for its new sleeping pill, Rozerem, which the Food and Drug Administration approved last year as the first sleeping medication not designated as a controlled substance.

The company and studies indicate the drug lacks the risk of chemical abuse or dependency that other prescription sleeping aids pose. Rozerem will compete against drugs such as Ambien and Lunesta, both of which list the potential for dependency in their labels.

Sales of sleeping pills are among the fastest-growing categories of prescription drugs. Critics credit the rise to large amounts of consumer advertising, particularly on TV.

In the United States, sales of brand-name prescription insomnia medications reached $2.8 billion last year, which is about double the sales in 2002, said IMS Health Inc, a pharmaceutical market research firm in Fairfield, Conn.

And with rapid growth came a parallel surge in concern that the drugs were causing memory loss, sleepwalking and even late-night eating binges.

Democratic Rep. Patrick J. Kennedy of Rhode Island named top-selling Ambien as part of the reason he became disoriented recently and crashed his car into a Capitol Hill security barricade. Kennedy noted that the drug's label warned users against operating heavy machinery.

Dr. Sidney Wolfe, director of health research for consumer group Public Citizen, noted that:

"The drug ads have created a much-expanded market so even people who do not have sleep disorders and could benefit from non-pharmacological [treatments] use them. And it's easier for doctors to just write out a prescription rather than take the time to figure out the causes for [their patients'] sleeplessness."

The American Medical Association last month urged a government moratorium on consumer drug ads so physicians have time to be educated.

Sources say Takeda will spend about $100 million on the Rozerem ad campaign, but the company would not confirm that figure.

Before launching the campaign, Takeda said it sought to educate doctors about Rozerem by sending 1,000 new sales representatives into medical offices across the country to address questions.

"We wanted to spend a year educating physicians on another approach to treating insomnia," said Tim Rudolphi, senior director of neuroscience at the Japanese drugmaker's U.S. headquarters in Chicago.

It's not yet clear if that approach was successful for the company; it would not disclose the first full year of sales for the drug. Analysts, though, have estimated that Rozerem garnered less than $100 million in sales in its first year.

With the advertising, some analysts are projecting that Rozerem will achieve more than $500 million in sales by 2009.

Rozerem is aimed at a market of 70 million Americans who "at some point in the year suffer some sort of insomnia," said Rudolphi, of Takeda. "Anybody who has trouble falling asleep is the ideal candidate."

Bruce Japsen writes for the Chicago Tribune.

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