Federal drug regulators indicate that side effects of the sleeping aid Lunesta may cause users to experience impairments and other problems the next day, leading to recommendations that starting doses be cut in half.
On May 15, the FDA issued a drug safety communication warning that initial doses of Lunesta may be too powerful. The agency indicates that it will require Sunovion, the manufacturer of Lunesta, to cut the starting recommended dose by half, from 2 mg to 1 mg.
The move comes following the findings of a study that showed Lunesta side effects may cause users to experience severe impairment the next morning, which could increase the risk of auto accidents or other injuries.
The FDA looked at a study using data from the National Prescription Audit Total Patient Tracker database for 2013. The double-blind study included 91 healthy adults between the ages of 25 and 40 years old. Researchers found severe psychomotor coordination impairment and memory impairment that lasted from 7.5 hours to 11.5 hours. The effects impacted both men and women the next morning after taking the Lunesta 3 mg recommended dose when compared to a placebo.
Lunesta (eszopicione) was approved by the FDA in 2004. It comes in both 1 mg and 3 mg pills, and originally had a starting recommended dose of 2 mg. Following the FDA announcement, which required Sunovion to change the label, the Lunesta prescribing information (PDF) has been updated to lower the starting dose to 1 mg.
The FDA advised doctors to be aware that Lunesta can cause next-day impairment of driving and other activities that require full alertness. The agency also noted that the dosing can be raised to 2 mg or 3 mg if needed, but should not exceed 3 mg. The maximum recommended dose for elderly patients and those with liver impairments should be 2 mg, the agency recommended.
The FDA warned that if a patient is prescribed 3 mg. doctors should caution that patient against driving or engaging in activities that may be dangerous or require mental alertness the next day.
“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” Dr. Ellis Unger, director of the FDA’s Office of Drug Evaluation, said in a press release. “Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs.”
The warnings and dosing reduction are similar to actions the agency took almost exactly a year ago regarding sleeping drugs like Ambien, which contain the active ingredient zolpidem.
On May 14, 2013, the FDA announced new label recommendations for Ambien and similar drugs that also cut their dosing in half, but for women, from 10 mg to 5 mg for immediate release products, and from 12.5 mg to 6.25 mg for extended release Ambien.
The FDA warns that the side effects of Lunesta appear to affect men and women, however.