Source: LA Times
Date: 17 January 2005

For insomniacs, a sleeping pill for every night

Lunesta is the first prescription sleep aid approved by the FDA for long-term use. It also carries a low risk of next-day grogginess.

By Melissa Healy, Times Staff Writer

The nation's insomniacs will need only to turn on late-night television in the next several months to learn there's a new kid on the block in the $2-billion market for sleep drugs.

In mid-December, the Food and Drug Administration approved a new prescription sleep aid — a hypnotic, in medical parlance — called eszopiclone. But while it is already the talk of the town among sleep-medicine specialists, the drug's manufacturer is planning a $60-million campaign to take the news directly to the sleepless and baggy-eyed in advertisements wedged between reruns, classic movies and political gabfests. On late-night TV, where insomniacs gather anyway, that'll buy a lot of advertising, and the drug, named Lunesta, is expected to be one of this year's most heavily marketed medications.

Lunesta breaks new ground on at least two counts. When taken at bedtime, the drug not only puts insomnia sufferers to sleep for a full six or seven hours; it also carries a low risk of grogginess the next day. This double-barreled approach offers a balm for those who tend to waken frequently during the night or too early in the morning.

Second, it is the first prescription sleep drug that the Food and Drug Administration has essentially declared safe and effective for long-term use. In approving other sleep medications, including the widely used medications Ambien and Sonata, the FDA has consistently cautioned that they should be used for short periods — usually no more than a week to 10 days — because longer-term studies of their safety and effectiveness have not been done.

Sepracor Inc., the Massachusetts-based pharmaceutical company that manufactures Lunesta, says it will dispatch an army of 1,250 sales representatives to promote the drug to primary care physicians, psychiatrists and hospital physicians — the doctors who are most often the first to spot and treat insomnia — about the new medication's value.

At an average wholesale price of $3.70 per tablet, Lunesta will not be a cheap sleep, however. It will cost about 75% more than Sonata and Ambien, the two new-generation sleep medications that, like Lunesta, are called non-benzodiazepines.

The newest drug is a derivative of a medication long available in Europe and Latin America. But in preparing the prescription sleep aid for FDA approval, Sepracor did not only sponsor short-term studies demonstrating the drug's effectiveness for those who sometimes can't fall asleep. It also launched five separate studies of the drug's use for chronic insomniacs — people who regularly have trouble falling or staying asleep. Several lasted six months, and one was extended to a year of continuous use, far longer than the 12-week trials that led to FDA approval of Ambien and Sonata.

An estimated 70 million people suffer from sleep disorders and wakefulness, according to the National Institutes of Health, and 60% of those are chronic insomniacs.

The studies of Lunesta found that patients taking it for the long haul did not build up a tolerance for the drug — a concern that worries many doctors who prescribe sleep aids for long periods. And when its use was stopped "cold turkey," according to Dr. Andrew Krystal, who ran one of the trials at Duke University, researchers found few to none of the withdrawal symptoms — including delirium and a worsening of insomnia symptoms — that patients sometimes experience when discontinuing other prescription sleep aids.

Krystal says the entry of eszopiclone into the field of sleep drugs probably will help broaden physicians' views of chronic insomnia and its treatment. Sleep specialists have long held that sleep difficulties must be a symptom of some underlying medical condition, such as depression, anxiety disorder, sleep apnea or restless leg syndrome.

"The problem we've come to appreciate is, there is a significant number of people — 15% of insomnia patients — who have long-term insomnia but no associated underlying condition we can identify," says Krystal. As primary care physicians find they have a medication approved for such patients' treatment, they may be more likely to offer help.

Doctors have long treated those patients with antidepressants and sleep aids that were not approved by the FDA for long-term use, and often were not approved as medications for insomnia at all. But although physicians frequently (and legally) prescribe medications for such "off-label" uses, "we were really not sure" what their long-term effects would be, says Dr. Michael J. Sateia, a professor of psychiatry at Dartmouth Medical School and president of the American Academy of Sleep Medicine.

The studies undergirding Lunesta's FDA approval should set many physicians more at ease and probably will encourage the makers of sleep medications already on the market to conduct long-term safety and effectiveness studies of their own.

For Terri Bagley, a 43-year-old owner of a housecleaning service in Pelham, N.C., and a chronic insomniac who had tried other sleep medications, Lunesta was, quite simply, the key to regaining a foothold on happiness. Bagley, who participated in Lunesta's one-year trial at Duke University Medical Center, said the drug brought quick sleep and relief from nighttime wakening, without the "hangover" she got from other sleep medications. "It made me feel happy. I'm a pretty happy person. But when you're not real tired all the time, you're even happier."

When Lunesta hits the streets, adds Bagley, "there'll be a lot more well-rested people out there. There may not be as much road rage."

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