FDA Requires Lower Doses for Sleeping Pills

The U.S. Food and Drug Administration (FDA) announced Thursday that it is requiring manufacturers of insomnia products which contain zolpidem, such as Ambien, Edluar and Zolpimist, to lower their current recommended doses.

For two decades, millions of Americans have taken Ambien to help them get a good night’s sleep. But for years, the FDA has received complaints of people feeling drowsy the morning after taking the medicine, some even getting into car accidents.

The active ingredient, zolpidem, causes drowsiness. Researchers have found high levels of zolpidem remaining in the blood of patients the morning after a dose was taken. They found it affected patients’ cognitive skills, including their ability to drive. Zolpidem is the most widely used sleep aid.

The FDA said using lower doses of zolpidem would cut down on the amount of the drug found in the bloodstream the following morning. Another reason the agency recommended lowering the dose for women is that women do not process zolpidem out of their system as quickly as men, since women take longer to metabolize the drug than men. An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving as long as eight hours after taking the pill, while only about 3 percent of men do, said Dr. Robert Temple, an official in the agency’s Center for Drug Evaluation and Research.

The recommended dosage the agency now suggests for women is 5 milligrams from the previous 10 milligrams for the immediate-release products and down to 6.25 milligrams from 12.5 milligrams for the extended-release products. Patients who use the extended-release version of these drugs are at an even higher risk of impairment the following morning, according to the FDA.

Sleeping pills have become so popular with today’s hectic lifestyle. According to IMS, a health care information and technology company, about 60 million prescriptions were filled in 2011, an increase of about 20 percent since 2006.  About 40 million were for products containing zolpidem.

There have been reports of after effects from sleeping pills for years, causing some doctors to question why the drug agency took this long to act. Not only were there incidents involving sleepy drivers, some patients report strange acts of texting, cooking complete dinners or having sex during the night without having any memory of it in the morning. This has been familiar to the medical community for years.

“In this case, the FDA may be behind the eight ball,” said Daniel Carlat, an associate clinical professor of psychiatry at Tufts University, referring to residual drowsiness. “Few doctors will be surprised hearing about this. They’ll say, ‘Oh, yeah, we’ve already seen this in our patients.” He added that Thursday’s announcement “will be good for public health because it will get patients to ask their doctors about the appropriate dosage.”

The FDA stated that the new labeling on the insomnia products will let doctors know that they should also consider a lower dose for men, as well, especially for those who experience difficulty concentrating the next morning.  The FDA advised that all patients should be warned about the possible “morning after” risks.

Agency officials acknowledged that they had received about 700 reports of driving mishaps with people on zolpidem over the years, with a spike in 2007 after a change in labeling caused more people to call in complaints.  Patients often did not remember what time they took the pill and some had been drinking, as well.

Dr. Carlat said one of his patients discovered that her weight gain while on the drug was from midnight trips to the kitchen that she did not even remember taking!

In making its recommendations, the FDA looked at findings from a large driving simulation study that showed some people taking products containing zolpidem had higher levels of the drug in their system and could not operate a vehicle as well as those who did not take the drugs, or who took lower doses.

Doctors can still prescribe the higher dose if the lower one does not work. The lower doses are already commercially available, Dr. Unger said, as they are recommended for older patients.

The drug manufacturers should have warnings clearly stating the dangers of “morning after” effects on the labels, as well as the doctors prescribing the medications, should discuss the risks with their patients. As with any medication, if you feel drowsy, you should use common sense before getting behind the wheel of a vehicle.   You take this medication to help you sleep at night; the only problem is you still feel sleepy during the day!

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