In a May 15 safety announcement, the FDA announced that it has decreased the recommended starting dose of the sleeping pill Lunesta to 1 mg at bedtime. The hypnotic drug Lunesta (eszopiclone) is indicated for the treatment of insomnia.
In 2013 the FDA made a similar decision to lower the recommended dose of the sleeping pill Ambien (zolpidem). Both decisions were based on safety concerns about lingering drowsiness caused by sleep medications.
“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,” FDA spokesperson Dr. Ellis Unger said in a news release.
The FDA cited data showing that impairment to driving skills, memory and coordination can last more than 11 hours after taking a 3 mg dose of Lunesta. Patients often were unaware that they were impaired.
The FDA noted that the 1 mg dose can be increased to 2 mg or 3 mg if needed. However, patients taking a 3 mg dose should avoid driving the next day. Older adults should not take doses of more than 2 mg. Lunesta should be taken once in the evening immediately before bedtime.
Patients are advised by the FDA to continue taking their prescribed dose of Lunesta. They should contact their health care professional to ask about the proper dose for them.
The AASM offers Ten Safety Tips for Taking Sleeping Pills for Insomnia.
