The Food and Drug Administration has approved a new, nonnarcotic therapy for insomnia, eszopiclone. Most sleep aids are approved for only short-term use of a week to 10 days, but eszopiclone can be safely prescribed for longer, according to the FDA.
Formerly known as Estorra and now called Lunesta, eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is manufactured and sold by Sepracor Inc. of Marlborough, Mass. The drug is expected to be available this month.
Eszopiclone was studied in six phase III randomized, double-blind placebo trials, three of which were included in Sepracor's FDA approval package. The drug was superior to placebo in sleep latency and sleep maintenance for transient insomnia and superior in sleep latency and total sleep time in five 6-month studies in chronic insomnia. In two 2-week studies of patients aged 65-86, eszopiclone was also superior to placebo.
There was no major impact on memory or cognitive function in any of the studies, and only about 1% of patients on the highest dose—3 mg—experienced withdrawal signs. In addition, there was very little rebound insomnia.
Patients who do not respond after 7-10 days of treatment may have an underlying psychiatric disorder, warns the label, which adds that the lowest possible effective dose should be used. Eszopiclone will be available in 1-mg, 2-mg, and 3-mg tablets, and it will likely sell for $3.70 a pill, according to Sepracor. The recommended dose is 2-3 mg for adults up to 65 years old and 2 mg for adults over age 65.
Eszopiclone is also in trials as an insomnia therapy for patients with depression, rheumatoid arthritis, perimenopause, and chronic insomnia.