Thursday, January 31, 2013

Why has the FDA recently required manufacturers of zolpidem-containing products (Ambien, Ambien-CR, Edluar, and Zolpimist) to lower dose recommendations?

The FDA recently required manufacturers of zolpidem-containing products (Ambien, Ambien-CR, Edluar, and Zolpimist) to lower dose recommendations, say California DUI attorneys.  

FDA has recommended lower doses of zolpidem containing drugs as a result of driving simulations that found that serum levels of zolpidem greater than 50ng/mL can adversely impact driving performance, California DUI lawyers are told. 

The cited reference points out that recent studies have shown that “8 hours after taking 10 mg Ambien, 15% of women and 3% of men had serum concentrations of zolpidem >50 ng/mL, say  California DUI attorneys.

With extended-release zolpidem 12.5 mg, 33% of women and 25% of men had serum concentrations greater than 50 ng/mL 8 hours after taking the drug.” (The Medical Letter, January 21, 2013, 55(1408):5)