FDA Cautions Women about Sleeping Pills

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One of the common warnings on sleeping pills is to watch for next-day difficulties in mental functioning.

Another warning, added by the FDA in 2009, cautions: ”Abnormal thinking and behavioral changes: Complex behaviors such as 'sleep-driving' (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem...”

Latest warnings concern dosage levels for women

Because women metabolize zolpidem (Ambien) and other sleep medications more slowly than men do, they are more prone to next-day mental effects. The recommendation is to cut the standard dose in half for women.

An ABC report said about one-third of women taking extended release formulations were impaired the next day. Impairment could mean an automobile crash, and studies in driving simulators have shown this to be the case. Men on zolpidem can also get the same effects, but at a lower percentage – approximately 25 percent of men will have some next-day impairment.

The FDA cautions that patients should not alter their dosages on their own without consulting their physicians first. They are also encouraged to report any unusual dizziness, drowsiness or confusion during the day, and any sleep-walking behaviors to their doctors.

Issues with blaming sleep aids for mental impairment

Other sleep medications are also being looked at by the FDA to determine if similar cautions should be issued. One problem is that those who suffer insomnia and take these prescription sleep aids may show signs of mental impairment because of poor sleep. Both the medications and the condition being treated can have similar effects, making it difficult to place the blame on one or the other.

The ruling may open the door for lawsuits based on next-day impairment that has led to injuries or accidents. Expect to see lawyers advertising for clients who were injured while taking zolpidem, with the expectation that the victim might have been affected mentally by the drug.

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