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FDA Approves New Kind of Sleeping Pill

Rozerem First Drug to Target Brain's Sleep Center

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"It is clear that something critical is happening at the end of waking time so the body lets us transition rather rapidly from being awake to being asleep," Neubauer tells WebMD. "A lot of this has to do with the SCN. And as [Rozerem] targets melatonin receptors in the SCN, it makes sense it can make a gearshift toward sleep."

What Sleep Doctors Say

Is Rozerem going to affect the way doctors treat patients?

"I am delighted to have another thing to offer to my patients," Neubauer says. "There will be a lot of interest. One -- because it is the first sleep drug in a very long time to have a new mechanism of action. And two -- I think there is going to be a very high comfort level in prescribing this drug. The safety level is extremely positive. A lot of doctors -- and a lot of patients who haven't been interested in a sleeping pill -- may view this in a different light and may be more comfortable giving it a try."

But Milton Kramer, MD, isn't sure Rozerem is going to be better than existing sleeping pills. Kramer is director of psychiatric research, Maimonides Medical Center, Brooklyn, N.Y.

"I don't think [Rozerem] is going to have an enormous impact," Kramer tells WebMD. "The issue is around the size of the change it accomplishes -- its effectiveness in chronic [sleeping-pill] users is not enormous. But people may see it as being a more 'natural' substance, and that may give it tremendous appeal."

Rozerem should be taken within 30 minutes before going to bed. It should not be taken with or immediately after a high-fat meal. Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.

The most common side effects seen with Rozerem were somnolence, dizziness, and fatigue. Rozerem should not be used in people with severe liver abnormalities.

Rozerem vs. Melatonin

So wouldn't over-the-counter melatonin supplements work as well as Rozerem? No, Mini says. Rozerem has a more potent effect on the sleep center of the brain than melatonin supplements. And unlike the supplement, Rozerem has been tested in well-designed studies.

"If you look at the melatonin data, and the recent NIH consensus panel statement, it says that there is little evidence to support the use of melatonin for the treatment of insomnia," Mini says. "And even at that, the dose needed for sleep promotion is unclear. Strict clinical trials of melatonin have not been done. It is an unregulated supplement."

According to the Takeda news release, Rozerem will be available for patients by late August.

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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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