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More Ambien (zolpidem) Risks For Women Come to Light

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Are you reading the inserts that come with prescription drugs? The pages of fine print about side effects, precautions and potential drug reactions? You should be reading, particularly if you’re taking sleeping aids like Ambien or the generic version zolpidem.

Last week ABC and CBS news reported about an alarming increase in the number of patients seen in the ER, as a result of taking zolpidem medications. The Substance Abuse and Mental Health Services Administration (SAMHSA) found that zolpidem, Ambien's active ingredient, was connected to roughly 19,500 ER visits in 2010 compared with 6,111 in 2005. Half of all ER visits tied to zolpidem in 2010 involved another drug. Anti-anxiety medications and narcotic pain relievers intensify the sedative effects of drugs like Ambien.

The FDA expresses specific concern about women, whose adverse reactions to zolpidem have risen substantially in the last several years. From 2005 to 2010 there was a 274% increase in number of women in the ER because of the medication—68% of all cases.

Women clear the drug from their system more slowly than men, putting them at increased risk. The extended-release form of the drug is considered more ‘worrisome’ according to the FDA statement. The FDA recommends doctors lower dosages for women and men. (CBS News 5/2)

An article in Chronic Neuroimmune Diseases provides the historical context on women and drug studies, helping put the Ambien risks for women into perspective:

Historically, women have been excluded from many clinical trials for a number of reasons. These include a perceived difficulty in recruiting and retaining women for studies, the confounding effects of female hormonal changes, and a desire to protect a potential fetus. Because of the last reason, the U.S. Food and Drug Administration (FDA) further exacerbated the situation in 1977, when it barred women of childbearing age from clinical trials. Hence, for nearly a decade and a half, many medical research studies, including breast cancer trials, were done almost entirely on men.

The NIH Revitalization Act of 1993, mandating the inclusion of women and minorities in clinical trials. In the same year, the FDA rescinded its restrictions on the participation of women of childbearing age.”

What does that mean for women? There’s still a good chance that your doctor is prescribing medications in dosages based on male clinical trials. The concerns about Ambien and zolpidem reflect the severity of this issue—not enough is known about how a female body reacts to medicines to accurately determine how much of a drug is enough or too much.

In the US we tend to regard doctors as God-like figures who know, with absolute certainty, what’s best for us. We often follow without questioning. Yes, the doctor is trained and does know what medications will help us, but do not hesitate to question your physician in order to ensure you getting the best medication for your unique needs. Become your own medical advocate, or designate someone for that role. When you get a new medication, read the insert in the box and be aware of potential side effects. Ask the pharmacist if there could be possible reactions with existing medications. With age, changes in health, and other conditions like weight gain/loss or pregnancy, it’s a good idea to ask the doctor to reevaluate medications and dosages.

If you’re one of the 44 million people taking Ambien or zolpidem-based sleep medications (ABC News 5/1) in combination with painkillers or antidepressants, you should consult your doctor today.