AASM statement on new FDA safety announcement for sleeping pills

FOR IMMEDIATE RELEASE:   January 10, 2013

CONTACT: Lynn Celmer, 630-737-9700, ext. 9364, lcelmer@aasm.org  

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.

“Sleeping pills can be a safe and effective treatment option for insomnia when used as prescribed by a licensed, board certified sleep medicine physician,” said AASM President Dr. Sam Fleishman. “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 their physician, who should always try to employ the lowest effective dose and taper the medi­cation when conditions allow.”

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: https://www.fda.gov/Drugs/DrugSafety/ucm334033.htm.

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.aasm.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.

2017-08-31T20:44:23+00:00 January 10th, 2013|Press Releases|