The FDA has made a major change to one of this country’s most popular drugs: Ambien. Millions of people take sleep aids each year, but now they might receive a different dosage from their doctor. The FDA is requiring all manufacturers of Zolpidem to change the dosage for women from 10 mg to 5 mg, and from 12.5 mg to 6.25 mg for extended-release tablets. They are recommending lower doses for men as well, but only requiring it for women. This is a significant move because 64% of the prescriptions written for Ambien are for women.
The FDA says that with this move, it hopes to reduce the number of people that find themselves impaired the day after taking Ambien and also hopes to reduce the number of strange hypnotic behaviors that some people taking this sleep aid have exhibited.
The studies that the FDA relied on showed that after 8 hours, with a 10 mg dose, 15% of women and 3% of men had levels of the drug in their system high enough to cause impairment. With the extended-release formulation, it was worse: 33% of women and 25% of men were impaired. The risks were much greater when the drug was combined with drugs or alcohol.
This is not the first headline for Ambien and other forms of this sedative-hypnotic. Once thought to be an improvement over older sleep aids by virtue of the fact that it had fewer side effects, it now has a list of bizarre problems all its own. Over the last years, more and more reports have surfaced of people engaging in bizarre behavior after taking Ambien and having completely amnesia regarding that behavior. One of the most common and dangerous forms of this behavior is sleep-driving, where a person gets into his or her car and often crashes it with no recollection whatsoever. Other reported behaviors include online shopping, eating, drinking, texting, and calling with complete amnesia.
Sanofi, the manufacturer of Ambien, unsurprisingly denies the severity of these issues: “Sanofi stands behind the significant clinical data demonstrating the safety and efficacy of Ambien, which was FDA approved in the US in 1992, and the 20 years of real-world use and 22 billion nights of patient therapy worldwide. Ambien CR was approved in the US in 2005.”
Ambien also received negative press last year when studies published in BMJ reported that users of sleep aids have a five-fold increased risk of death than non-users. Users were three times more likely to die even if they only took the pills twice a month. This was not a cause and effect relationship between sleeping pill usage and death, but instead an association.
If you have been injured by Ambien, or have suffered side effects that have led to bizarre behavior, contact us for a free consultation.
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