FDA Recommends Lower Ambien Doses

The Food and Drug Administration (FDA) this morning announced that they have required manufacturers of zolpidem (brand names Ambien, Ambien CR) to revise dose recommendations because of concern about next-morning impairment in patients who take these medications for sleep. These impairments (in driving ability for example) can occur even when patients do not feel sleepy after awakening.

The new recommendations include a dose adjustment for women to 5 mg of the immediate release zolpidem (Ambien) or 6.25 mg of the sustained release zolpidem (Ambien CR).  For men, these lower doses should be considered, but FDA is not requiring dose changes.

For either men or women taking either the 10 mg or 12.5 mg dose of zolpidem (Ambien or Ambien CR), a trial at the lower dose is certainly appropriate.  If you take the immediate release 10 mg tablets, these can be broken in half.  Do not break the 12.5 mg Ambien CR tablets; let us know if you would like to try the 6.25 mg dose, or an alternative medication and we will arrange a prescription.

If you take the immediate release form and breaking the 10 mg tablet in half works well, please let us know so that we can update your medication list in our office.

While the FDA will not allow manufacturers to recommend the current 10 mg and 12.5 mg doses for use in women, other medications are frequently used at doses outside the recommended range.  It is not clear whether women who do not respond to the lower dose will be allowed to continue as previously.  

These recommendations apply to neither zaleplon (Sonata) nor eszopiclone (Lunesta) but trials of lower doses of these medications are certainly reasonable as well.

Reviewed / Posted by: Scott W. Yates, MD, MBA, MS, FACP

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