WASHINGTON (May 15, 2014) The U.S. Food and Drug Administration says the maker of Lunesta must lower the starting dose of the sleeping aid drug because of the risk of morning drowsiness, which can interfere with driving ability and lead to injury.
The FDA is taking action based on a study that found Lunesta at recommended doses can cause problems with driving, memory and coordination for as long as 11 hours after first the drug is taken.
Patients are often unaware that they are still drowsy.
Lunesta manufacturer Sunovion Pharmaceuticals will lower the starting dose of the tablet to 1 milligram from 2 milligrams.
Patients can increase their dose, but should remember that higher doses are more likely to cause impairment the next day, the FDA said.
Drowsiness is a side effect for all anti-insomnia drugs.