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Middle-of-Night Sleeping Pill Intermezzo Approved

Before Driving, Users Must Wait 1 Hour After Waking, 5 Hours After Dose
By
WebMD Health News
Reviewed by Laura J. Martin, MD

Nov. 23, 2011 -- Insomniacs wide awake in the wee hours now have a get-back-to-sleep pill -- Intermezzo.

The FDA approved the pill on Wednesday. Designed by Transcept Pharmaceuticals for people who wake in the middle of the night, the drug is a fast-acting, low-dose form of zolpidem (best known as Ambien at its higher bedtime dose).

Citing safety concerns, the FDA had twice previously refused to approve Intermezzo. The FDA had one main worry: that people might get up and try to drive before the drug fully wears off. Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others.

Responding to FDA concerns, Transcept changed the Intermezzo label to state that the drug should only be taken when people have at least four hours of sleep time remaining. And the label tells people not to drive for at least one hour after waking and at least five hours after taking Intermezzo.

Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids.

Waking During the Night

"For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," Robert Temple, MD, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. "With this lower dose, there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

Men clear zolpidem from their systems about twice as fast as women do. Transcept therefore offers Intermezzo in two dosages: a 3.5-milligram dose for men and a 1.75-milligram dose for women, taken only once per night.

Zolpidem in its full-dose, taken-at-bedtime form is best known as Ambien, made by Sanofi-Aventis. It's also available as a generic drug. Other forms of zolpidem include an under-the-tongue tablet (Edluar), a spray mist (Zolpimist), and an extended-release pill (Ambien CR).

Side Effects

Intermezzo, like other sleeping pills, can cause serious side effects. These include getting out of bed not fully awake and being unaware of doing things or remembering you did them.

Activities reported to the FDA while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking. Alcohol or other sleep medicines increase the risk of doing such things.

Like Edluar, Intermezzo is an under-the-tongue tablet designed for quick release. But Intermezzo contains only a quarter to a third as much zolpidem. And it is the only form approved for middle-of-the-night use.

And like other forms of zolpidem, Intermezzo is a controlled substance that can be abused or that can lead to drug dependence.

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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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