FDA Issues New Dosage Recommendations For Insomnia Drugs

Posted on January 11, 2013

A number of drug items that are meant to help users overcome insomnia have received new recommendations from the Food and Drug Administration.  If you take such a drug, then you might want to read on.

Zolpidem is the name of the drug that has prompted this additional FDA scrutiny.  The drug can be found in products more commonly known as Ambien, Zolpimist, Edluar, and other generics.  Drowsiness has for some time been listed on the label as one of the potential side effects of the drug.  Alertness can be compromised even a day after the drug has been taken, and the impact on a person’s mental faculties could lead to a dangerous driving situation or some other precarious incident.

However, the FDA now believes that the threat to alertness is greater than originally thought.  Data shows that the risk of impairment is considerable on versions of the drug that offer extended-release therapy.  The FDA also believes that women are more at risk than are men.  This is due to the female body generally eliminating the active drug ingredient at slower rates than their male counterparts.

The FDA is thus advising that the makers of the drugs cut recommended dosages for females in half to prevent a potential accident.  They ask doctors to fully brief patients as to the side effects and to prescribe as low a dose as safely possible.

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