Skip to content

    Sleep Disorders Health Center

    Font Size
    A
    A
    A

    FDA: Start Sleep Drug Lunesta at Lower Dose

    Agency points to studies showing daytime drowsiness that could interfere with driving

    WebMD News from HealthDay

    By Robert Preidt

    HealthDay Reporter

    THURSDAY, May 15, 2014 (HealthDay News) -- Some users of the popular sleep medicine Lunesta remain too drowsy for safety during the day, and the recommended starting dose for the medicine should be lowered, the U.S. Food and Drug Administration said on Thursday.

    In a statement, the agency said it took the action due to studies showing that levels of Lunesta (eszopiclone) in some patients may remain high enough in the morning to interfere with driving and other activities that require them to be mentally alert.

    This impairment can occur even if patients feel fully awake, the FDA said.

    "To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia," Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

    The recommended starting dose of Lunesta -- taken at bedtime -- has been reduced from 2 milligrams (mg) to 1 mg for both women and men, which means that less of the drug will remain in the body the next morning.

    The dose can be increased to 2 mg or 3 mg if needed, but those higher doses are more likely to reduce alertness the next morning, the FDA noted.

    The agency advised that patients who are currently taking 2-mg or 3-mg doses of Lunesta discuss the issue with their doctor, deciding on how to keep taking the drug safely and at a dose that best suits them.

    One of the studies cited by the FDA included 91 healthy adults, aged 25 to 40. It found that currently recommended doses of Lunesta could hamper driving skills, memory and coordination for as long as 11 hours after taking the drug. Despite these effects, patients often did not realize they were impaired.

    Prescribing information on Lunesta's label will be changed, and the same changes must be made to the labels of generic versions of eszopiclone, the FDA said. The agency also wants doctors to caution patients taking Lunesta about the risk of impaired alertness the next morning.

    Next-day drowsiness is a common side effect of all insomnia drugs, the FDA noted.

    In 2013, the agency ordered a dose reduction for sleep drugs with the active ingredient zolpidem, such as Ambien and Ambien CR.

    Today on WebMD

    fatigued senior woman
    We’ve got 10 tips to show you how
    Man snoring in bed
    Know your myths from your facts.
     
    Young woman sleeping
    What do your dreams say about you?
    woman eith hangover
    It’s common, and really misunderstood.
     

    Is This Normal? Get the Facts Fast!

    How Many Hours Did You Sleep Last Night?
    Is that amount of sleep typical for you?
    Did you get enough sleep to feel alert today and function at your best?

    Get the latest Sleep Disorders newsletter delivered to your inbox!


    or
    Answer:
    0-6
    7-8
    9+

    Your level is currently

    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."

    Did You Know Lifestyle Choices
    Impact Your Sleep?

    Use the WebMD Sleep Tracker to track
    your ZZZs over time.

    Get Started

    This tool is intended only for adults 18 and older.

    Start Over

    Step:  of 

    Young woman sleeping
    Quiz
    Cannot sleep
    Video
     
    child sitting in bed
    Article
    Woman with insomnia
    Quiz
     
    nurse sleeping
    ARTICLE
    Foods That Help Or Harm Your Sleep
    SLIDESHOW
     
    Insomnia 20 Tips For Better Sleep
    Slideshow
    Pain at Night
    ARTICLE