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FDA approves sleep aid for long-term use

Utah M.D. says drug reportedly can be used 'chronically, safely'

Published: Monday, Jan. 24 2005 10:14 a.m. MST

There's a new weapon for the estimated 100 million Americans who suffer from chronic or occasional insomnia.

The Food and Drug Administration in December approved Lunesta (eszoplicone) for people who have trouble falling asleep or staying asleep.

Manufacturer Sepracor will launch the medication, the first specifically approved by the FDA for long-term use, this month.

"What the company is happy about is study demonstrated you can use it chronically, safely," said Dr. Robert J. Farney, medical director of the Intermountain Sleep Disorders Center at LDS Hospital.

Package inserts on other drugs specify short-term use.

"In practice, people use them longer all the time. But this is the only one with FDA approval," he said.

Eszoplicone also lasts longer than other sleep aids, so it's effective for people troubled by early morning awakenings.

"It helps at the beginning of the night and lasts long enough,"

Farney said.

Patients sometimes complain they get to sleep but they still wake up too early, leaving them chronically tired.

Adequate sleep is essential for good health. During sleep, the brain recharges. Normal sleep drifts between rapid eye movement (REM) and non-REM states. The latter has four stages from drowsiness to deep sleep, where the most positive, restorative effects of sleep occur. People who don't get enough suffer.

REM and non-REM occur in 90-minute cycles, according to the National Sleep Foundation.

People who drive without adequate sleep can be as impaired as someone driving drunk, according to federal transportation officials.

Insomnia is common, but it doesn't mean just an occasional sleepless night. It's a "subjective complaint that there's something wrong with your sleep. It's important when it bothers your waking, daytime function," Farney said.

"It doesn't matter unless it's disturbing you in some way. People often have transient insomnia, but it becomes a problem when it's persistent."

Reluctance to take sleep aids may perpetuate a pattern that could be broken, he said. He talks about patients in stressful situations who develop sleep disorders. Their friends and family tell them to just relax.

"The solution is giving them a sleeping pill now and then," Farney said. "People incorrectly avoid using them when they ought to be using them. What's stressful is not sleeping and you don't want that to become perpetual. We should be intervening."

Sleeping medications are not, however, the first step, he warned. First, a physician must "exclude reasonably" other causes of poor sleep, including psychological factors such as anxiety or depression disorders, respiratory problems like sleep apnea or restless leg syndrome. Inability to sleep may be an indication of an underlying and possibly serious medical condition. All of those require their own treatment. Once other causes have been excluded, Farney said medication may be appropriate.

Poor sleep quality may also be a product of poor sleep hygiene. Sleep experts suggest a variety of steps to induce sleep, including bedtime rituals and rules. One of the most important is avoiding naps. Also, those who cannot sleep should not lie in bed and worry about it. It's better to get up and do something else until they're tired.

Eating, exercising or drinking caffeine too close to bedtime can interfere with sleep, as well.

Eszoplicone is a non-benzodiazepine sleep aid that is a reformulation of a medication that has long been used in other countries, Farney said.

Sepracor is conducting ongoing studies of the medication in patients who have insomnia, those with insomnia who also have depression or pain and in women experiencing perimenopause.


E-mail: lois@desnews.com

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