FDA lowers Lunesta dose due to next-day drowsiness

Published on NewsOK Modified: May 15, 2014 at 12:57 pm •  Published: May 15, 2014
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WASHINGTON (AP) — Federal health officials are lowering the starting dose of the popular sleeping aid drug Lunesta, due to risks of morning drowsiness that can impair driving ability and lead to injury.

The Food and Drug Administration said Thursday it is taking action based on a study that found Lunesta users had problems with driving, memory and coordination up to 11 hours after first taking the drug. Patients are often unaware that they are still drowsy the morning after, according to the FDA.

The results, published last month, compared 91 patients taking Lunesta or placebo while performing several tasks measuring coordination, memory and other cognitive measures.

Lunesta manufacturer Sunovion Pharmaceuticals will lower the starting dose of the tablet to 1 milligram from currently available 2 milligrams. Patients can increase their dose to 2 or 3 milligrams, but should keep in mind that higher doses are more likely to cause next-day impairment, according to the FDA statement.

Patients currently taking 2 or 3 milligram doses of Lunesta should contact their doctor to get information about the most appropriate dose.