The FDA recently issued a safety announcement about the potential risks associated with the sleep aid Lunesta (eszopiclone). Lunesta is a sedative-hypnotic medicine used to treat insomnia. The FDA is warning that the drug” can cause next-day impairment of driving and other activities that require alertness.”
The safety announcement was prompted by a study which showed that Lunesta can impair “driving skills, memory, and coordination [for] more than 11 hours after receiving an evening dose.” Furthermore, “patients were often unaware they were impaired.” As a result, the FDA has approved changes to Lunesta’s prescribing information, lowering the recommended starting dose from 2 mg to 1 mg. The initial dose can be increased up to 3 mg, but in such cases, patients are cautioned not to engage in “activities that require complete mental alertness the day after use.”
In addition, the FDA is also evaluating the risk of impaired alertness with all sleep aid drugs, including over-the-counter pills.