A year and a half after the FDA required manufacturers to reduce recommended dosages of Ambien for women, there is a call to reduce the standard dosage of Lunesta. According to a federal study, roughly four percent of US adults took a sleeping medication, like Lunesta or Ambien, in a given month between 2005 and 2010. “In 2013, the FDA said, approximately 3 million prescriptions of Lunesta were dispensed to nearly a million patients in the United States. Lunesta, made by Sunovion Pharmaceuticals, also recently became available in generic form. The new rules, including changes to existing labels, will apply both to the brand-name and generic forms of the drug.”
The FDA decision is based in part on a 2012 British study of 91 adults, ages 25 to 40, taking a three-milligram dose of Lunesta (the recommended dosage is two mg.). The FDA cited this finding – “severe next-morning psychomotor and memory impairment in both men and women” – in its recommendation. As long as 11 hours after dosage researchers found signs of impaired driving skills, coordination and memory,although individuals reported feeling alert. Based on this research, with the previous concerns about Ambien, the FDA wants the recommended dose to be lowered from two milligrams to one milligram. “Using lower doses means less drug will remain in the body in the morning hours,” the FDA said in a statement.
“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” Ellis Unger, of FDA’s Center for Drug Evaluation and Research, said in a statement. This is a general rule for most medications – take the lowest dose possible that is effective.
This seems like a relatively simple fix for an alarming problem. The pharmaceutical manufacturers reduce recommended dosages and doctors advise their patients to take less of the medication. The human factor comes into play if patients are dependent on their sleeping aids and fear that a reduced dosage of their medication, be it Lunesta, Ambien or one of the other popular sleeping drugs, might not give them the blissful night’s sleep. As researchers point out, doctors can always monitor the patient and increase dosages if necessary. This is both a safety and drug dependency issue. There were 55 million prescriptions for sleeping pills in 2013 alone. Are that many Americans experiencing severe, chronic sleep issues? Or is the lure of a quick fix the answer? The pharmaceutical ads for sleeping medications assure us of a peaceful night’s sleep, with the implicit promise of a less stressful life. Potential problems functioning the next are not really discussed in the advertisements.
The FDA decision should be an easy one for the pharmaceutical companies. Reduced dosages might just mean the sale of more pills. There is unlikely to be a proportional decrease in the sale price.
The potential for safety issues arising with the accidental misuse, or the abuse, of sleeping pills is extraordinary. The FDA’s move is understandable. Have we as a society, however, become too dependent on both over-the-counter and prescription drugs? What did our ancestors do to achieve a good night’s sleep? Did they suffer in silence, or did they not need sleeping aids because of a less sedentary lifestyle? The debate over whether we, as a society, are over-medicated will go on, but the fact remains that these pills are here to stay, and they are worth their weight in gold to those who frequently suffer from insomnia. If you are one of the latter, hopefully you are managing your usage in conjunction with your doctor’s recommendations, and, most importantly, will not need these pills long-term.