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Published On: Sun, Jan 13th, 2013

FDA recommends lower bedtime dose for Ambien, other insomnia drugs

AmbienImage/DEA

Ambien
Image/DEA

The active ingredient in numerous insomnia drugs, zolpidem, can cause impairment in morning activities like driving at current doses according to the US Food and Drug Administration (FDA). This new information has prompted the regulatory agency to require lower bedtime doses in drugs that contain zolpidem such as brand named drugs Ambien, Ambien CR, Edluar, Zolpimist and generics, according to a FDA Safety Announcement Jan. 10.

The FDA said current recommended doses of Ambien and similar drugs should be cut in half for women and that the labeling should recommend doctors consider a lower dose for men.

According to the announcement:

FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products

FDA officials decided on the new requirement after driving simulations and laboratory studies showed that eight hours after taking the medication, as many as 15 percent of women and 3 percent of men still had enough of the drug in their systems to impair driving “to a degree that increases the risk of a motor vehicle accident”, according to a Washington Post report. 

The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for  men, according to the FDA.

The FDA is advising health care practitioners to prescribe the lowest dose capable of treating the patient’s insomnia.

 

See the FDA Q&A concerning this new requirement

 

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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  1. Ambien and other sleep aids seen in huge increase in ER visits: SAMHSA - The Global Dispatch says:

    […] In January this year, the FDA said current recommended doses of Ambien and similar drugs should be cut in half for women and that the labeling should recommend doctors consider a lower dose for men. […]

  2. Ambien and other sleep aids account for huge increase in ER visits: SAMHSA - The Global Dispatch says:

    […] In January this year, the FDA said current recommended doses of Ambien and similar drugs should be cut in half for women and that the labeling should recommend doctors consider a lower dose for men. […]

  3. Dr. Puckett talks about Sleeping Pills and Insomnia – KTVO says:

    […] a news anchor and reporter with KTVO. read more » · Become a Fan · Follow Us …FDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchFDA Warns About Side Effects of Insomnia MedicineCounsel & HealFDA requiring […]

  4. Dr. Puckett talks about Sleeping Pills and Insomnia – KTVO says:

    […] a news anchor and reporter with KTVO. read more » · Become a Fan · Follow Us …FDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchFDA Warns About Side Effects of Insomnia MedicineCounsel & HealFDA requiring […]

  5. FDA Warns About Side Effects of Insomnia Medicine – Counsel & Heal says:

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  6. FDA to require more driving simulation tests – Philadelphia Inquirer (blog) | Health News says:

    […] understand whether and how zolpidem affected …FDA proposes changes to sleep aid dosagesWXXAFDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchFDA orders recommended dosages of sleeping pills to be halvedMcKnight’s […]

  7. FDA to require more driving simulation tests – Philadelphia Inquirer (blog) says:

    […] orders recommended dosages of sleeping pills to be halvedMcKnight’s Long Term Care NewsFDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchCounsel & Healall 5 news […]

  8. S says:

    No wonder I felt so out of it when I was on Ambien…As far as I can tell Lunesta doesn’t have zolpidem, which is why Lunesta didn’t give me the hungover feeling. Anyway, I’ve found success with a few OTC options. Check out my blog for my reviews: http://www.squidoo.com/otc_insomnia_meds

  9. FDA proposes changes to sleep aid dosages – WXXA says:

    […] containing the drug zolpidem, which is sold under the brands Ambien, Edluar and Zolpimist.FDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global Dispatchall 2 news […]

  10. FDA recommends lower bedtime dose for Ambien, other insomnia drugs – The Global Dispatch says:

    […] FDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchThe active ingredient in numerous insomnia drugs, zolpidem, can cause impairment in morning activities like driving at current doses according to the US Food and Drug Administration (FDA). This new information has prompted the regulatory agency to …FDA proposes changes to sleep aid dosagesWXXAall 2 news articles » […]

  11. FDA recommends lower bedtime dose for Ambien, other insomnia drugs – The Global Dispatch says:

    […] FDA recommends lower bedtime dose for Ambien, other insomnia drugsThe Global DispatchThe active ingredient in numerous insomnia drugs, zolpidem, can cause impairment in morning activities like driving at current doses according to the US Food and Drug Administration (FDA). This new information has prompted the regulatory agency to …FDA proposes changes to sleep aid dosagesWXXAall 2 news articles » […]

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