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Ad push looms for sleep aids

New class of drugs to spur competition

Terri Bagley spent nearly two decades searching for a way to get a good night's sleep.

She toyed with keeping her bedroom pitch black and sniffing in the soothing smell of lavender. But neither those tricks nor over-the-counter and prescription medications made much of a difference.

Bagley, a 44-year-old operator of a small cleaning service in Pelham, N.C., is typical of the millions of Americans believed to suffer from chronic insomnia who until recently had mostly short-term solutions available. She found help in a clinical trial for Lunesta, one of a new generation of prescription sleep medications, and continued taking the drug after it hit the market in April.

''If you're tired for 20 years, you don't realize how much better you can feel until you start getting a full night's sleep again," she said.

An emerging class of sleep aids is spurring an advertising effort that industry watchers say could rival the saturation campaign for erectile dysfunction drugs. ''I would expect this to become a very active category of drugs in consumer advertising," said Judy Franks, of Starcom Worldwide, a Chicago-based ad buying agency.

US advertising for prescription and over-the-counter insomnia drugs totaled nearly $68 million last year, according to TNS Media Intelligence, a media research firm. But spending in the first four months of this year alone was already $48.7 million; at that rate, it could top $146 million this year.

Lunesta is so far the only prescription sleep aid approved by the Food and Drug Administration for long-term use, in contrast with more established short-term medications such as Ambien and Sonata. While most of the eight FDA-approved sleep aids tend to lose their effectiveness after about a week of use, Lunesta has been shown in Sepracor-funded studies to remain effective for up to six months.

Some of the emerging new insomnia medications are believed to enhance the action of so-called GABA receptors within the brain believed to promote sleep, while minimizing the side effects more common to older drugs.

The short-term indication labeling on older drugs put doctors ''into a very difficult double-bind," said Dr. John Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital in Boston. ''Patients complaining of chronic nightly sleeplessness were being treated with medicines that were only for short-term use. Now that double-bind has been lifted."

At least two other medications could win US regulatory approval later this year or early next year. Pfizer Inc. and San Diego-based Neurocrine Biosciences Inc. are teaming up to develop indiplon, a GABA-receptor drug.

Sepracor Inc., the Marlborough-based manufacturer of Lunesta, is spending $60 million this year on ads for the drug. Lunesta averaged about 60,000 new prescriptions per week after its launch, and Sepracor reported yesterday that the drug posted $83.5 million in second-quarter sales. The company increased its forecast of Lunesta sales for the full year from $160 million to $220 million.

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