AASM Statement on New FDA Safety Announcement for Sleeping Pills

Ten Safety Tips for Taking Sleeping Pills for Insomnia

The AASM advises all physicians to prescribe sleep medications according to the new dose requirements and offers important safety tips for patients

DARIEN, IL – A new FDA safety announcement requiring lower recommended doses for some common sleeping pills contains important information for both physicians and patients, reports the American Academy of Sleep Medicine.

The FDA announced today that drug makers will be required to lower the recommended doses for products used to treat insomnia that contain the drug zolpidem, including the popular sleeping pills Ambien and Ambien CR.  New dose recommendations also are required for the medications Edluar and Zolpimist. 

The FDA decision was based on concerns about potential drowsiness occurring the morning after taking a sleeping pill, particularly among women.  Such daytime drowsiness can be a health and safety risk, especially while driving.

AASM says that sleeping pills can be a safe and effective treatment option for insomnia when used as prescribed by a licensed physician.  The FDA safety announcement is a reminder that all medications may cause some side effects, and sleeping pills are no exception.  It is critical that patients who take sleeping pills receive ongoing treatment supervision from a physician, who should always try to employ the lowest effective dose and taper the medi­cation when conditions allow, AASM says.

As a reference for physicians, the AASM offers a comprehensive “Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults.”  Patients are encouraged to visit the AASM website at www.sleepeducation.com, where they can review the Ten Safety Tips for Taking Sleeping Pills for Insomnia.

About 70 million Americans suffer from sleep problems that may prevent them from sleeping well.  Anyone with chronic insomnia or another ongoing sleep problem should seek help from a board certified sleep medicine physician and the team of medical professionals at an AASM accredited sleep disorders center. A directory of AASM accredited member sleep centers is available online at www.sleepeducation.com.

Source: FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist).  Jan. 10, 2013.  Available from:  http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm.

Ten Safety Tips for Taking Sleeping Pills for Insomnia

Follow these guidelines to make sure that you use sleeping pills safely and properly to treat insomnia:

  • Never take a sleeping pill without first getting approval from your doctor.
  • Make sure your doctor is aware of any other medications that you already take.
  • Notify your doctor if you have any other medical problems such as high blood pressure or liver problems.
  • Carefully read the package insert that comes with your medication.
  • Follow your prescription.  Do not take more than the dosage that your doctor prescribes.
  • Never drink alcohol near the time when you take a sleeping pill.
  • Only take a sleeping pill when you will have enough time to get a full night of sleep (7 to 8 hours).
  • Try to take the first dose on a night when you don’t have to go anywhere the next morning.
  • Never drive a motor vehicle after taking a sleeping pill.
  • Contact your doctor or pharmacist right away if you have any problems while taking a sleep medication.
  • Contact a local sleep center to get help for insomnia or another sleep illness.

Pete Friedmann, 847-859-9510, pete.friedmann@flcomm.com
Jonathan Lehrer, 847-859-9510, jonathan.lehrer@flcomm.com
Lynn Celmer, 630-737-9700, ext. 9364, lcelmer@aasmnet.org

The AASM is a professional membership society that is the leader in setting standards and promoting excellence in sleep medicine health care, education and research (www.aasmnet.org)

The American Academy of Sleep Medicine considers sleep disorders an illness that has reached epidemic proportions. Board certified sleep medicine physicians in an AASM accredited sleep center can provide effective treatment. AASM encourages patients to talk to their doctors about sleep problems or visit www.sleepeducation.com for a searchable directory of sleep centers.

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The American Academy of Sleep Medicine is a professional membership society that is the leader in setting standards and promoting excellence in sleep medicine health care, education and research (www.aasmnet.org) The AASM considers sleep disorders an illness that has reached epidemic proportions. Board certified sleep medicine physicians in an AASM accredited sleep center can provide effective treatment. AASM encourages patients to talk to their doctors about sleep problems or visit www.sleepeducation.com for a searchable directory of sleep centers.

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About 70 million Americans suffer from sleep problems that may prevent them from sleeping well.
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AASM says that sleeping pills can be a safe and effective treatment option for insomnia when used as prescribed by a licensed physician.
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Quotes

The FDA safety announcement is a reminder that all medications may cause some side effects, and sleeping pills are no exception.
American Academy of Sleep Medicine
It is critical that patients who take sleeping pills receive ongoing treatment supervision from a physician, who should always try to employ the lowest effective dose and taper the medi­cation when conditions allow.
American Academy of Sleep Medicine
Never take a sleeping pill without first getting approval from your doctor.
American Academy of Sleep Medicine