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.
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 timerather than one immediate dose, as is typically the case with over-the-counter melatoninthe 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 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.
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.
In the pipeline: In higher doses, the drug doxepin is used to treat depression and anxietybut 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.
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.