Ad War Over Sleep Aids Predicted

Campaigns Could Rival Recent Flood Of Erectile Dysfunction Spots

(AP) 
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 a week or so of use, Lunesta has been shown in Sepracor-funded clinical 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 U.S. 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 which hasn't yet been given a brand name. And Japan-based Takeda Pharmaceuticals is developing Rozerem, a drug that targets receptors of the natural hormone melatonin in an area of the brain that regulates the body's sleep-wake cycle.

Like the heavily marketed erectile dysfunction drugs, the new insomnia medications are aimed at people who have gone largely untreated and may be unaware of new treatment options.

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.

Drug makers are trying to overcome concerns about addiction that were related partly to older barbiturate sleep aids, as well as lingering drowsiness associated with over-the-counter antihistamines.

"A lot of doctors have been historically somewhat reticent to prescribe these drugs, so a patient-driven marketing approach makes sense," said analyst David Steinberg of Deutsche Bank North America.