FDA Lowers Recommended Sleeping Pill Doses

Pharmaceutical attorneys at Pintas & Mullins Law Firm would like to highlight a recent development in the sleeping aid industry. Amid reports of dangerous side effects, drug agencies are now recommending that women should only take half the usual dose.

Ambien, perhaps the most notorious of all sleeping pills, is one of the most widely prescribed medications in the country. It has been estimated that up to 10% of American adults at least occasionally use sleeping pills. In our over-caffeinated and demanding society, the abundance of sleeping pills comes as no surprise. Many Americans, however, are experiencing serious and dangerous side effects. The New York Times recently released a story with specific recommendations from the FDA on how to counter these adverse effects.

The FDA has been receiving complaints about Ambien and its successors for years, stating the medication causes extreme morning drowsiness, even causing some users to get into car accidents. After numerous laboratory and driving tests, the FDA just announced that women should only be taking half their usual dosage. This applies any drugs containing zolpidem, which is the active ingredient in most sleep aids. Of the 60 million sleeping aids prescribed in 2011, 40 million contained zolpidem.

Women take longer to metabolize pharmaceuticals than men. An estimated 10 to 15% of women have enough zolpidem in their blood after taking a sleeping aid to impair their driving for eight hours. Only 3% of men experience the same level impairment. FDA officials estimate that they have received 700 reports of zolpidem-impaired car accidents throughout the years. The agency is now telling manufacturers that recommended dosages for women should be lowered to 5 milligrams for immediate-release products such as Ambien, Zolpimist, and Edluar, and to 6.25 milligrams for extended-release drugs.

An even more disconcerting article by U.S. News reveals that popular sleeping pills like Ambien and Restoril are linked to nearly five times increased risk of premature death. The article is based off a new study by Scripps Health, a non-profit health system based in San Diego. Researchers estimated that, in 2010 alone, sleeping pills may have contributed to up to 500,000 excess deaths in the U.S.

The study, which was published in the British Medical Journal, pursued 10,000 Pennsylvania residents prescribed to sleeping pills and 23,500 residents not using sleeping pills, between 2002 and 2006. About 6% of the prescribed residents died during that period, compared to only 1% of non-users. At first, the team considered that perhaps the drugs were being prescribed to people more prone to sickness, with a higher body mass index, or who had a secondary illness such as diabetes or asthma. No matter how they reconsidered and regrouped the data, however, the risk was always the same: those prescribed to sleeping pills have a 3.5 to 5% higher risk of dying.

Alarmingly, the study also found that those heavily using sleeping pills were 35% more likely to develop a major cancer. Sanofi, the company that manufactures Ambien, is adamantly refuting these findings, saying the study is flawed, limited, and questionable. Representatives state that not being able to sleep is often an indication of other, more serious disorders. The San Diego research team is currently considering follow-up studies to better determine specific causes of death and any underlying conditions. One of the study’s authors states that their unique algorithm considered studied persons’ age, race, and reported alcohol and tobacco use to best verify if there were any circumstances contributing to mortality rates.

Despite the study’s possible shortcomings, these results are extremely troubling. Insomnia and other sleep disorders affect an estimated 50 to 70 million Americans, and prevent them from functioning normally. Other known and common side effects of sleeping pills include heart problems, depression, worsened sleep apnea, and impaired judgment. Any underlying conditions affecting the sleep cycle, such as heart disease or diabetes, should be treated as a first priority.

Dangerous drug attorneys at Pintas & Mullins Law Firm remind the public that no drug can be considered completely free of risk. Sleep disorders are often merely a symptom of a greater, more serious health problem. If you or someone close to you was severely injured from sleeping aid side effects, you may be entitled to compensation, and should contact an experienced pharmaceutical lawyer.


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