FDA Scrutinizes Popular Sleeping Pill and Cuts Starting Dosage, Warns of Next-Morning Impairment


A popular prescription sleeping pill has been linked to "severe" next-morning motion and memory impairment. FDA cuts starting dosage in half and requires a change to the drug label.

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As many as 50 to 70 million Americans suffer from sleep disorders or sleep deprivation, according to the Institute of Medicine. An estimated 8.6 million Americans take prescription sleeping pills.

While popular prescription drugs like Lunesta (eszopiclone) and Ambien (zolpidem) have provided relief to those suffering from sleepless nights, the drugs also brings on risks, like impairment to mental alertness.

After a recent review of data from clinical trials and other types of studies, the Food and Drug Administration (FDA) announced on Thursday that it is requiring the manufacturer of the sleep drug Lunesta to change the drug label and lower the current recommended starting dose to half – from 2 milligrams to 1 mg for men and women.

The lower dosage is to address the risk of impairment the morning after, which impacts driving and other activities that require full alertness. Using a lower dose means less drug will remain in the body in the morning hours.

“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,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research in a press release.

The FDA required cutting the dosage in half for the starting dose. Dosage thereafter may increase if needed to 2 mg or 3 mg, but the higher the dose, the more likely impairment results the next day.

In the recent data from clinical studies that were evaluated by the FDA, it showed Lunesta was linked to “severe” next-morning motion and memory impairment 7.5 hours after taking the drug. Some impairment continued for as long as 11 hours and there were cases where individuals were unaware they were impaired. The studies also found no difference between how men and women responded, so the requirement for a lower dosage applies to all patients taking Lunesta.

In early 2013, the FDA also cut the recommended dose for Ambien and its extended-release form – another popular prescription sleeping pill for the risk of next morning impairment.

The FDA is continuing to scrutinize the possible risk of other sleeping pills, including those sold over the counter for possible risk of impairment to mental alertness.

FDA further warns that after taking Lunesta “alertness can be impaired even in people who do not feel drowsy.”

[Source: FDA; Institute of Medicine.]