FDA Cuts Lunesta Dosage in Half Because of Drug’s Lingering Morning Effects

On Behalf of | Jun 3, 2014 | Personal Injury

The Food and Drug Administration (FDA) recently announced that it is requiring the makers of the sleeping aid Lunesta to change the recommended starting dose on the product. Studies have shown that there may be high enough levels of the drug left in patients the morning after that could possibly impair any activity that requires alertness and focus, such as driving. This side effect may be present even in patients who feel as if they are fully awake.

Currently, the recommended starting dose is two milligrams. But the FDA has ordered manufacturer Sunovion Pharmaceuticals to change the labels and the patient medication guide to now reflect a recommended starting dose of one milligram. If needed, then the dosage may gradually be increased.

According to a study conducted by the Center for Disease Control (CDC), approximately nine million people in the U.S. take a prescription sleeping aid to help fall asleep. Last year alone, nearly 55 million sleeping aid prescriptions were dispensed by pharmacies across the country. Two of the most popular drugs prescribed are Lunesta (eszopiclone) and Ambien (zolpidem).

Last year, the FDA reduced the recommended dose for women by half for Ambien and other sleeping aids that contained zolpidem. Ambien users have reported issues with amnesia and erratic behavior while using the drug.

The FDA based their most recent decision on a study conducted by Surrey Clinical Research Center in Britain. Researchers there found that people who had taken three milligrams of Lunesta at night had frequent episodes of severe impairment to their motor skills and their memory. The study also found that even two milligrams of the drug could stay in a person’s system for up to 11 hours, affecting alertness and coordination.

If you have been injured or left impaired by an improperly prescribed drug, contact an experienced New Braunfels personal injury attorney to find out what compensation you may be entitled to for pain and loss.