16-Jan-13 8:00 AM  CST

FDA Requiring Lower Recommendations For Various Sleep Aids

You may or may not have heard the news that the FDA is requiring a lower recommended dose for certain sleep aids, including Ambien and its counterparts Ambien CR, Edluar, and Zolpimist.  The recommended dose is based on evidence found in driving simulation and laboratory studies completed on some patient’s blood levels the next morning when taking zolpidem.  The blood levels appear capable of impairing driving activities to a dangerous level and can increase the risk of having an automobile accident.  The new suggested doses are as follows: 
  • New recommended doses for women have been lowered from 10 milligrams to 5 milligrams for immediate release pharmaceuticals (Ambien, Edluar, and Zolpimist) and 12.5 mg to 6.25 mg for extended-release tablets (Ambien CR).    
  • New suggested doses and recommended label changes for men have been lowered from 5 mg for immediate-release products and 6.25 mg for extended-release products. 
In addition to these new dosages, the FDA reminds healthcare providers and the public that ‘morning-impairment’ is not limited to the drug zolpidem.  Morning-impairment can be a result of taking other sleep aids as well. 

Recently, a representative from the FDA commented in a press release concerning the lowered of doses of zolpidem.  “To decrease the potential risk of impairment with all insomnia drugs, healthcare professionals should prescribe, and patients should take the lowest dose capable of treating the patient’s insomnia,” said Ellis Unger, M.D., and Director of the Office of Drug Evaluation 1 and FDA’s Center for Drug Evaluation and Research.  Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their healthcare professional about whether their sleep medicine is appropriate,” said Unger. 

1.  Walsh, Sandy.  “FDA Requiring Lower Recommended Dose For Certain Sleep Drugs Containing zolpidem.”  FDA.Gov.  Web.  10 Jan 2013.     

2.  Clark, Daniel & Lisa Stark.  “FDA:  Cut Ambien Dosage For Women.”  ABC News.  Web.  10 Jan 2013.    

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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