FDA recommends lower starting dose for Lunesta

May 16, 2014

FDA has required the manufacturer of sleep drug eszopiclone (Lunesta) to lower the starting dose from 2 mg to 1 mg.

FDA has required the manufacturer of sleep drug eszopiclone (Lunesta) to lower the starting dose from 2 mg to 1 mg. Data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake, according to an FDA statement.

Patients currently taking the 2 mg and 3 mg doses of Lunesta should contact their healthcare professional to ask for instructions on how to continue to take their medicine safely.

"As a method of not only providing optimal patient care but also ensuring safety, the lower dosage labeling requirement for Lunesta is information that all prescribing providers should be aware of and strive to implement accordingly in every patient with a document diagnosis of insomnia or other sleep disturbance," according to Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

The approval of the nonbenzodiazepine drug class (eg, Ambien, Sonata, and Lunesta) has become a mainstay on the market and has led to improved quality of life for many Americans who suffer from sleep disturbances, according to Dr Farinde.

"The inability to engage in normal activities of daily living or daily functioning due to lack of sleep or other sleep-related issues is recognized as one of the primary reasons that people ultimately seek out treatment," she said. "The problem begins to affect an individual’s ability to function on an occupational, academic, or social level and people seek out a variety of remedies to treat this ailment whether pharmacological or non-pharmacological in nature." 

Within recent years, there have been reports that this drug class leads to usual behaviors. Ambien was first to be identified as causing this issue and a subsequent dose recommendation was made to lower its starting dose.