Local Physician Perturbed By FDA Recommended Dosage Cuts For Sleeping Meds (with Video)

By Jeff Neumeyer

February 26, 2013 Updated Feb 26, 2013 at 6:39 PM EDT

INDIANA, (www.incnow.tv) --- Finding a balance -- making sure government regulation of health care doesn't interfere with the ability of doctors to effectively treat their patients.

We examine a case involving sleep medication that has a local physician frustrated.

Dr. James Stevens, a Fort Wayne sleep disorders specialist, believes the U.S. Food and Drug Administration is going too far in regulating dosages of popular sleeping pills, and he fears this is only the beginning.

When a Fort Wayne woman recently sought a re-fill of Zolpidem, the generic form of Ambien, she was told by her doctor and pharmacist that she can only get 5 milligram tablets now, not ten as before.

That's because the FDA is now requiring the manufacturers of widely-used sleep drugs to cut recommended dosages in half.

The FDA maintains the drugs wear off more slowly in women, boosting their risk of being drowsy and driving impaired the next morning.

Dr. Stevens insists these drugs have been thoroughly tested and this intervention is not necessary.

" Doctors do the best in their judgment on what to do for that particular patient, so the FDA doesn't have a laundry list of everything that's appropriate and inappropriate for all circumstances and all treatments for patients," said Stevens, who is an MD in the areas of Neurology and Sleep Disorders.

The downside of simply going along with the new FDA requirements is that a number of patients complain 5 milligram dosages aren’t sufficient to deliver a good night’s sleep.

The FDA changes apply specifically to women, but the agency is also encouraging doctors to consider prescribing the same lower dosages to men as well.

Dr. Stevens is concerned we may see more situations like this one, given the fact some of the revisions associated with “Obamacare” trigger in 2014.

He and other physicians are claiming we'll see the government and insurance companies take a bigger role in treatment decisions following implementation of the new national health care law.




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