A new study shows prescription sleeping pills bring an increased risk of dying early—or getting cancer. So why is FDA rubber-stamping such dangerous drugs?
Sleep deprivation is a serious issue. As many as 70 million Americans suffer from insomnia and other sleep disorders. Some 60 million prescriptions for sleeping pills—technically called hypnotic drugs—were filled in 2011 as compared to 47 million in 2006.
Stress, an over-full lifestyle, poor diet, and especially the use of artificial light in the evening after going to bed, can all prevent sleep. As we reported earlier this year, lack of sleep makes you more likely to get sick, raises your risk of type 2 diabetes, high blood pressure, and obesity, and makes you more prone to depression.
Some of the risks of sleeping pills are already well-documented: daytime drowsiness, headaches, nausea, dizziness, and addiction. But a new study published in the British Medical Journal says that people taking a prescription sleeping pill—even when taking fewer than eighteen pills per year—have nearly four times the mortality rate of those who don’t take the drugs. And patients who take higher doses of sleeping pills have a 35% increased cancer risk.
This study was prompted by earlier studies showing that hypnotic drugs are often deadly when mixed with alcohol or other drugs, are linked to an increased risk of car accidents and falls, may raise risk of suicide, and may damage chromosomes in cells which could lead to cancer.
What was significant about this study is that it was long-term, keeping track of 10,529 people who had at least one prescription for a sleeping pill between 2002 and 2007, compared with a control group. While the study doesn’t demonstrate causation, it did adjust for confounding factors such as age, smoking, weight, and other health conditions.
So why is FDA approving such dangerous sleeping pills? For one thing, the clinical trials required for FDA approval may be inadequate when it comes to hypnotic drugs. Many people take non-benzodiazepine sedative hypnotics for years, even though most are approved for only short-term use and their safety and effectiveness were not evaluated beyond several weeks in clinical trials. (One exception is Lunesta, which was tested for up to six months, and its list of known side effects is terrifying.)
Compare this to the FDA’s standard for supplements: the NDI draft guidance requires “25 years of widespread use” in order to meet the “history of safe use” standard, which must be met even for grandfathered supplements. (For more on grandfathered ingredients, see our article in this issue.) As the Life Extension Foundation points out, the safety testing required by FDA is wildly inappropriate for supplements, and is unnecessary for natural products with years of documented safe use. Yet despite their superb track record for safety, FDA and the media have cultivated an environment of fear around nutritional supplements—while maintaining a casual attitude toward dangerous (but approved) drugs.