U.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. It will be distributed under the name Lunesta.
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 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."
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. It's 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 28% more expensive than Sonata and about 10% more expensive than 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. In preparing the prescription sleep aid for FDA approval, Sepracor sponsored short-term studies demonstrating the drug's effectiveness for those who sometimes can't fall asleep as well as five separate studies of the drug's use for chronic insomniacs - people who regularly have trouble falling or staying asleep.
Several of the studies 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 percent 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 percent of insomnia patients - who have long-term insomnia but no associated underlying condition we can identify," Krystal said. As primary care physicians find they have a medication approved for such patients' treatment, they may be more likely to offer help.
