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FDA Approves New Restless Legs Syndrome Drug

Drug, Called Horizant, Is Taken Once Daily
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WebMD Health News
Reviewed by Louise Chang, MD

April 7, 2011 -- The FDA has approved a new drug, Horizant Extended Release Tablets, as a once-daily treatment for moderate-to-severe restless legs syndrome

Restless legs syndrome (RLS) is a disorder that causes a strong urge to move the legs. People who have restless legs syndrome describe unpleasant feelings in their legs, such as pulling, itching, tingling, burning, or aching. Moving their legs temporarily relieves these feelings. The urge to move often happens when someone is inactive. The symptoms typically are worse in the evening and early morning.

"People with restless legs syndrome can experience considerable distress from their symptoms. Horizant provides significant help in treating these symptoms," Russell Katz, MD, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, states in an FDA news release.

The FDA approved Horizant based on two 12-week studies done in adults. Those studies showed improvement in restless legs syndrome patients taking Horizant compared to those taking a placebo.

Horizant's active ingredient is gabapentin enacarbil, which becomes gabapentin in the body. Gabapentin is an antiseizure drug that is also used to treat RLS. Lifestyle changes -- such as exercising, building healthy sleep habits, and cutting back on caffeine, alcohol, and tobacco -- are also recommended.

The FDA states that Horizant "may cause drowsiness and dizziness and can impair a person's ability to drive or operate complex machinery." Like all antiseizure drugs, Horizant will carry a warning about the risk that it may cause suicidal thoughts and actions in a small number of people. Horizant will also come with a medication guide outlining its uses and risks.

Horizant is not recommended for patients who must sleep during the daytime and remain awake at night, according to a news release from the drug companies GlaxoSmithKline and XenoPort, which developed the drug.

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You say you are able to function well with fewer than seven hours of sleep. Some people say they can function on four to six hours of sleep each night, but research shows that adults who get fewer than seven hours of sleep — whether for just one night or over the course of days, weeks, or months — have more difficulty concentrating and more mood problems than people who sleep seven to nine hours.

Since you usually get too little sleep, please talk to your doctor about your sleep patterns. Poor quality sleep can affect many areas of your life and health, and your doctor may be able to help you if you have insomnia or other conditions affecting your sleep.

Sleep deprivation can have both short- and long-term consequences. Learn more about the health consequences of sleep loss. If you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

It's not surprising you feel that you're not functioning at your best today. Some people say they can function on four to six hours of sleep each night, but research shows that adults who get fewer than seven hours of sleep — whether for just one night or over the course of days, weeks, or months — have more difficulty concentrating and more mood problems than people who sleep seven to nine hours.

Since you usually get too little sleep, please talk to your doctor about your sleep patterns. Poor quality sleep can affect many areas of your life and health, and your doctor may be able to help you if you have difficulty sleeping, have insomnia, or have other sleep disorders.

Learn more about the health consequences of sleep loss. If you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

It's not surprising you feel that you're not functioning at your best today. Some people say they can function on four to six hours of sleep each night, but research shows that adults who get fewer than seven hours of sleep — whether for just one night or over the course of days, weeks, or months — have more difficulty concentrating and more mood problems than people who sleep seven to nine hours.

It's good that you usually do get more sleep, since sleep deprivation can have both short- and long-term consequences. Learn more about the health consequences of sleep loss. And if you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

You say you are able to function well with fewer than seven hours of sleep. Some people say they can function on four to six hours of sleep each night, but research shows that adults who get fewer than seven hours of sleep — whether for just one night or over the course of days, weeks, or months — have more difficulty concentrating and more mood problems than people who sleep seven to nine hours.

It's good that you usually do get more sleep because sleep deprivation can have both short- and long-term consequences. Learn more about the health consequences of sleep loss. And if you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

It's not surprising you feel that you're not functioning at your best today. Some people say they can function on four to six hours of sleep each night, but research shows that adults who get fewer than seven hours of sleep — whether for just one night or over the course of days, weeks, or months — have more difficulty concentrating and more mood problems than people who sleep seven to nine hours.

Since you usually get less sleep, please talk to your doctor about your sleep patterns. Poor quality sleep can affect many areas of your life and health, and your doctor may be able to help you if you have difficulty sleeping or have insomnia or other sleep disorders.

Learn more about the health consequences of sleep loss. If you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

It's wonderful that you got a good night's sleep last night. Many people struggle to do so. Having a good sleep routine often is the key to getting the quality sleep night after night that your body needs for optimal health. Whether your sleep routine involves taking a warm bath, reading a book, or meditating, it's important to keep your bedtime and routine consistent every night and wake up around the same time every morning.

Click here to read more about the importance of sleep. If you're concerned about having trouble falling asleep, staying asleep, or sleeping too much, assess your risk for a sleep disorder.

It's unfortunate you're not functioning at your best today. You say you had a good quantity of sleep last night, but maybe the quality of your sleep is not as good as it could be? Having a good sleep routine — including a consistent bedtime and wake time — often is the key to getting the quality sleep night after night that your body needs for optimal health. Since you usually sleep this amount, if you often aren't feeling your best, you should consider talking to your doctor. Could you have an underlying condition? Are you feeling anxious or depressed? Have you taken medication that disrupted your sleep? Do you or could you have sleep apnea? Or do you naturally require a little bit more sleep?

Although sleep is crucial for optimal health, some research suggests that sleeping too much can also have negative consequences. Learn more about sleep. If you're concerned about having trouble falling asleep, staying asleep, or sleeping too much, assess your risk for a sleep disorder.

It's unfortunate you're not functioning at your best today. You say you had a good quantity of sleep last night, but maybe the quality of your sleep is not as good as it could be? Having a good sleep routine — including a consistent bedtime and wake time — often is the key to getting the quality sleep night after night that your body needs for optimal health. Since you usually sleep longer, if you often aren't feeling your best, you should consider talking to your doctor. Could you have an underlying condition? Are you feeling anxious or depressed? Have you taken medication that disrupted your sleep? Do you or could you have sleep apnea? Or do you naturally require a little bit more sleep?

Although sleep is crucial for optimal health, some research suggests that sleeping too much can also have negative consequences. Learn more about sleep. If you're concerned about having trouble falling asleep, staying asleep, or sleeping too much, assess your risk for a sleep disorder.

It's wonderful that you got a good night's sleep last night. Many people struggle to do so. Having a good sleep routine often is the key to getting the quality sleep night after night that your body needs for optimal health. Whether your sleep routine involves taking a warm bath, reading a book, or meditating, it's also important to keep bedtime consistent and wake up around the same time every morning.

Although sleep is crucial for optimal health, some research suggests that sleeping too much can have negative consequences. Learn more about sleep. If you're concerned about having trouble falling asleep, staying asleep, or sleeping too much, assess your risk for a sleep disorder.

It's unfortunate you're not functioning at your best today. You say you had a good quantity of sleep last night, but maybe the quality of your sleep is not as good as it could be? Having a good sleep routine — including a consistent bedtime and waking up at the same time — often is the key to getting the quality sleep night after night that your body needs for optimal health.

Since you usually get less sleep, please talk to your doctor about your sleep patterns. Poor quality sleep can affect many areas of your life and health, and your doctor may be able to help you if you have insomnia, another sleep disorder, or conditions affecting your sleep.

Learn more about the health consequences of sleep loss. If you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

It's wonderful that you got a good night's sleep last night. Many people struggle to do so. Having a good sleep routine often is the key to getting the quality sleep night after night that your body needs for optimal health.

Since you usually get less sleep, talk to your doctor about your sleep patterns. Poor quality sleep can affect many areas of your life and health, and your doctor may be able to help you if you have insomnia or another sleep disorder or conditions affecting your sleep.

Learn more about the health consequences of sleep loss. If you're concerned about having trouble falling asleep or staying asleep, assess your risk for a sleep disorder.

SOURCES:

Centers for Disease Control and Prevention (CDC). Effect of short sleep duration on daily activities--United States, 2005-2008. MMWR Morb Mortal Wkly Rep 2011; 60:239.

Carskadon, MA, Dement, WC. Normal Human Sleep: An Overview. In: Principles and Practices of Sleep Medicine, Fifth, Kryger, MH, Roth, et al. (Eds), Elsevier Saunders, St. Louis, MO 2011. p.16.

Harvard University: "Sleep, Performance, and Public Safety."

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