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Elusive Sleep, Elusive Cure

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TIMES HEALTH WRITER

There was no such thing as a good night’s sleep for Sharon Brontrager.

For most of her life, she approached bedtime the way most people approach a date in traffic court--with lots of anxiety about the outcome.

“I asked my doctor for different things. I tried melatonin, Tylenol PM, an antidepressant,” says Brontrager, 53, a retired travel agent in Cincinnati. She avoided some other insomnia medications, fearing side effects that were worse than her sleep deprivation, and became resigned to having to live with constant daytime fatigue.

Brontrager finally decided to volunteer for a research study of an experimental insomnia drug after researchers told her the therapy would not cause next-day side effects. To her delight, the medication not only produced no side effects but also helped her fall asleep without the usual angst. The drug, called zaleplon, is due to go on the market next month under the trade name Sonata.

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Sonata is expected to be popular with insomnia sufferers, possibly prompting more patients to seek help for the condition and more doctors to ask about an affliction that about 84 million Americans suffer from chronically.

“Only about 5% of people with chronic insomnia actually visit their doctors specifically for that problem,” says Gary Zammit, director of the Sleep Disorders Institute, affiliated with Columbia University College of Physicians and Surgeons in New York. “So there is a mismatch between the magnitude of the problem and the coverage of the problem in the health care setting.”

The lack of appealing treatment options is thought to be a big reason why insomnia goes unresolved, Zammit says.

“A lot of doctors may not have felt comfortable with the current options in medication,” he says. “Patients may also have been concerned about dependence or being hooked on a sleep drug. There may have been some duplicity in not addressing the problem.”

It’s not always easy to know what to do about insomnia. Lots of people have occasional trouble falling asleep or staying asleep. People with chronic insomnia, however, are those who have trouble sleeping for three weeks or longer.

Numerous Factors Can Cause Insomnia

Insomnia can be caused by stress, anxiety, depression, pain, disease, medications, sleep disorders or poor sleep habits, according to the National Sleep Foundation, a nonprofit organization in Washington, D.C., devoted to promoting good sleep and understanding sleep disorders. Insomnia is very common among workers who frequently alternate between daytime and nighttime work hours (65% suffer from it) and people over age 65 (12% to 25%).

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The disorder leaves misery in its wake. Americans spend about $14 billion a year on insomnia treatments, and millions more are spent on indirect costs, such as absenteeism.

“If you talk to people with insomnia,” Zammit says, “they will tell you their productivity drops by about 20% on the days they’ve had insomnia. And work quality also drops 20% after a night of insomnia. There is real impairment associated with insomnia.”

Insomnia is also blamed for about 100,000 auto accidents a year, according to the National Highway Traffic Safety Administration. People with insomnia are also four times as likely to suffer from depression than those who sleep well.

“We now have good data that if you have insomnia your risk of having depression goes way up,” Zammit says. “So I think people need to be attentive to their symptoms and impairment and, if they are having a problem, they should talk to their doctor.”

Chronic insomnia is difficult to treat and often doesn’t go away on its own. Typically, people who are treated for insomnia undergo a physical exam by their primary care doctor to try to determine the cause. Insomnia caused by pain, for example, would be treated with pain medication.

Short-term insomnia, which most people occasionally experience, lasts a few days or weeks and is usually caused by jet lag or changes in sleep patterns, says Michael Wincor, an associate professor at the USC School of Pharmacy and Medicine.

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When the cause of insomnia is more complex or simply unknown, doctors will usually try one, or both, of two approaches: prescription medication and behavioral therapies.

Behavioral therapies focus on your sleep habits. Patients may be advised to exercise during the day; go to sleep at the same time every night; relax with a bath or by listening to music; and to avoid daytime napping, eating too close to bedtime, and caffeine, alcohol or nicotine.

Some Treatments Take Too Much of an Effort

But behavioral therapies require motivation, discipline and practice--attributes that some people lack, says Wincor.

That’s why doctors often suggest behavioral therapies in combination with sleep medication. In a study of insomnia in people age 65 and older, published in a March issue of the Journal of the American Medical Assn., researchers found that a combination of drug therapy and cognitive-behavior therapy worked better than either method alone.

Until the early part of the decade, prescription drugs for insomnia consisted of a class of medications called benzodiazepines, which are hypnotics. These medications included Halcion, Dalmane, Xanax, Valium and Restoril.

While these drugs do shorten the time it takes to sleep and improve sleep quality, they have significant side effects, Wincor says. They are not safe when taken with alcohol, can leave you drowsy or forgetful the next day and can lead to dependence (and withdrawal symptoms) when taken for a long time. Most doctors will only prescribe them for short-term use (usually four weeks) or for long-term but intermittent use.

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“Benzodiazepines are all sedating. They are muscle-relaxants, tranquilizers and all cause memory impairment,” said Martin Scharf, of the Tri-State Sleep Disorders Center in Cincinnati, and a lead investigator of Sonata.

A few years ago, a different kind of medication called a nonbenzodiazepine came on the market. This drug, Ambien, avoids some of the more severe side effects produced by the older medications.

The new medication, Sonata, is also a nonbenzodiazepine. The special appeal of Sonata, which is made by Wyeth-Ayerst, is that it has a short “half-life,” a scientific term meaning that the medication works quickly and clears from the body quickly.

In studies of 2,800 patients, Sonata helped most to fall asleep within 30 minutes without significant side effects or any next-day effects. Sonata was approved by the U.S. Food and Drug Administration in August and will be on the market pending completion of a Federal Drug Administration review of the substance.

“Most people don’t like the idea of taking a pill every night. With a drug with a short half-life, you can take it when you need it. This is unique,” Scharf says. “It makes sense to have a rescue; something to help right then and there and won’t increase the need for a medicine the next night.”

The downside of such an approach, notes Wincor, is that it could perpetuate the problem of not being able to go right to sleep.

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“It allows you the opportunity to see if you can fall asleep on your own. But for some people, that could lead to undesired conditioning. They start out learning that they can’t fall asleep until they get up and take their Sonata.”

Sonata also may not be the best choice for someone who tends to wake up during the night or early morning, Wincor says. The medication works by helping people fall asleep but may have less effect on their staying asleep the entire night.

Brontrager took Sonata for about a year as part of the research trial.

“It still took me an hour and a half to two hours to fall asleep, which is less than I usually take,” she says. “But it never gave me any side effects.”

Unfortunately for the retired travel agent, the insomnia returned when the study ended and she no longer had access to Sonata. She hopes to begin using the medication again when it comes on the market and when her medical insurer will pay for it.

For now, she’s waiting sleeplessly.

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