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New sleep medications could reach pharmacy shelves in 2009.
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If you've ever taken medicine to help you sleep, you're probably in one of two camps: Either it worked well and provided much needed relief—or it was a waste of money, caused a slew of side effects, and left you wondering what better options were out there. While there are plenty of sleep drugs available to treat everything from insomnia to restless legs syndrome, they haven't stopped the pharmaceutical industry from searching for newer, more effective, and more profitable medications.

No new prescription sleep drugs hit the market in 2008, but research in several fields is under way. "I'm excited about a lot of these new drugs," says Lisa Shives, MD, president and medical director of Northshore Sleep Medicine in Evanston, Ill., and spokesperson for the American Academy of Sleep Medicine. "The brain is a complicated setup with approximately 17 different neurotransmitters involved in the sleep-wake cycle and, as soon as we fully understand all of them, drugs will present better solutions for sleep disorders."

Here, some potential treatments that could soon help you rest easier—and suggestions for what to do in the meantime.

For jet lag or shift work
In the pipeline: Two clinical trials have found that a new medication called tasimelteon helped subjects whose sleep pattern had been shifted forward by five hours fall asleep faster and sleep for longer. The drug, called a melatonin analogue, works by targeting melatonin receptors in the brain. Melatonin is the naturally occurring hormone that helps regulate the body's sleep-wake patterns. Unlike existing benzodiazepine-hypnotic sleep medications, melatonin analogues have shown no tendency toward addiction or dependence. The manufacturer of tasimelteon hopes the product will be available to patients within the next few years.

For now: While there's no drug specifically approved for helping jet lag sufferers sleep, Dr. Shives explains that taking over-the-counter melatonin "one or two hours before your new adjusted bedtime" for two to four days before an east-bound flight can help your body transition. (East-bound flights are typically tougher on sleep schedules than west-bound flights.) Upon arrival at your destination, you would take melatonin at your desired bedtime, and then upon your return home, you'd take it again at your regular bedtime to help readjust. Read more about melatonin.

For age-related sleep issues
In the pipeline: Circadin, a new drug developed in Israel, may help people 55 and older get much-needed sleep, as melatonin levels in their brains decrease as a consequence of aging. By slowly releasing small amounts of melatonin over time—rather than one immediate dose, as is typically the case with over-the-counter melatonin—the drug has been shown to help people sleep thorough the night without sacrificing next-day alertness. Already available in several European countries, Circadin is expected to be offered stateside sometime in 2009.

For now: The first thing Dr. Shives recommends is a thorough examination to determine the cause of the sleeplessness, whether it's insomnia or an underlying problem like sleep apnea. For insomnia, she recommends patients try cognitive behavioral therapy along with low doses of prescription nonbenzodiazepines, such as Ambien, Lunesta, or Sonata, which have been shown to cause relatively low incidences of grogginess and next-day alertness problems. Although she does not recommend it, she notes that it was common in the past for people to take over-the-counter antihistamines for their sedating properties. "If an antihistamine doesn't say it's non-drowsy, it will make you drowsy," she explains. "But we should always be careful when using antihistamines because they may have the opposite affect and make older patients feel wide awake." Read more about sleep and aging.


For those who can't sleep through the night
In the pipeline: U.S. Food and Drug Administration approval is pending for Intermezzo, a new medication to help insomnia sufferers fall back to sleep when they wake up in the middle of the night. The lozenge, which dissolves on the tongue in about two minutes, contains 28% of the active ingredient zolpidem, which is found in Ambien and its generic version. This lower dosage allows Intermezzo's effect to wear off in three or four hours, making waking up in the morning easier.

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Why not just take half of a stronger pill? "The doses come in 1.75 and 3.5 milligrams, so it's not quite the same as cutting a [5- or 10-milligram] Ambien in half," explains Dr. Shives.

For now: If you're taking these medications as directed and still wake up in the middle of the night, talk to your doctor about altering your plan. You might consider changing medications, raising your dosage, adding a shorter acting drug to your regimen, or taking half of a pill when you wake up. (Some medications, though, such as Ambien CR and other time-release formulas, will not work properly when cut in half.) Read more on prescription sleep aids.

For restless legs syndrome
In the pipeline: Calming jittery legs may one day be as easy as slapping on a Band-Aid. The medicated skin patch Neupro, which is approved in Europe for the treatment of Parkinson's disease, was shown to help relieve RLS symptoms in a July 2008 study. Neupro contains the dopamine agonist rotigotine and is designed to be applied once a day to offer 24-hour support for moderate to extreme suffers. Although the rotigotine patch was previously available in the United States for the treatment of early-stage Parkinson's disease symptoms, it was pulled off the market in April 2008, due to problems with its delivery system. The manufacturer plans to initiate proceedings with the FDA in 2009 to bring the patch back to the U.S. market.

Another new drug, called Solzira, has also shown promise in the treatment of RLS. Unlike previous dopamine agonist RLS medications, Solzira's active ingredient is gabapentin —an anticonvulsant drug currently approved to treat epilepsy and also commonly prescribed off-label to relieve hot flashes. (It's also commonly used to treat migraines and chronic pain.) Clinical trials have shown safety and effectiveness in easing RLS symptoms in the course of 12 weeks, and the FDA recently asked Solzira's manufacturer to reorganize and resubmit its application for drug approval consideration.

For now: The prescription dopamine-agonist Requip became available as the generic ropinirole in May 2008, giving RLS sufferers a less expensive treatment option. The other leading drug approved for restless legs syndrome, Mirapex, is still available as a brand name only. Read about drug-free treatment options.


For insomnia
In the pipeline: In higher doses, the drug doxepin is used to treat depression and anxiety—but at doses as small as 3 to 6 milligrams, it has been shown to help insomniacs too. The drug's sedative abilities improved the total sleep time of those involved in a clinical trial. Silenor, the proposed trademark name, is expected to receive FDA review by February 28, 2009.

For now: "There have been lots of clinical studies showing that cognitive behavioral therapy does better in the long run for people with chronic insomnia," Dr. Shives says. "But it can be hard to find CBT physicians, they're not always covered by insurance, and it takes at least four to eight sessions before it begins to work. For those patients are willing to try CBT, sometimes they need short-term medication as well." Watch how medications and behavioral changes can work together to help you sleep.

For sleep apnea
In the (not-too-near) pipeline: The severity of sleep apnea might be related to levels of omega-3 fatty acids in the body, researchers from the University of Missouri in Kansas City reported in a 2008 study. Of the 350 test subjects, those with lower body levels of docosahexaenoic acid (DHA), a type of omega-3 fatty acid, had more severe cases of apnea. It's not clear yet whether severe apnea lowers DHA levels, or whether less DHA leads to worsening apnea. More studies are certainly required, but if this link is established, a DHA-derived drug treatment is a possibility.

Dr. Shives is hopeful that drug therapies that target the brain's neurotransmitters may hold promise for patients with sleep apnea. "If you asked me a couple of years ago if we'd ever have another treatment besides the CPAP machine, I'd have said no," says Dr. Shives, referring to the continuous positive airway pressure device. "But it all goes back to the neurotransmitters." The same chemicals that control the sleep-wake cycle may also control the tone and stiffening of the muscles in your throat that keep the airway open, she explains. If researchers can develop a pill to activate those neurotransmitters to keep throat muscles toned, in theory, airway tissues wouldn't collapse and sleep apnea could be lessened or even avoided.

For now: Though it's too early to draw any specific guidelines from the University of Missouri research, you can increase your omega-3 intake by adding fish and nuts to your diet. And though sometimes uncomfortable, the CPAP machine has proven results. Read more about sleep apnea treatments.

It's estimated that it takes an average of 12 years and nearly $500 million to get a new drug from the lab to pharmacies—and even once a drug is approved, post-marketing studies are often just beginning. The fact that these medications have shown promising results is encouraging, but there's no guarantee that they'll solve your specific sleep problems or even make it to the market. Until you can try them for yourselves, talk to your doctor about healthy habits, relaxation techniques, and current treatment options that can help you get your z's.
Last updated: Dec 11, 2008