Sepracor, Inc., has announced the FDA’s approval of its New Drug Application (NDA) for the sleep aid eszopiclone (Generic Lunesta, formerly Estorra™).
The recommended dosage for improving sleep onset or maintenance is 2 or 3 mg for adults and 2 mg for adults 65 years of age and older). The 1-mg dose is indicated for sleep onset in older adults whose primary complaint is difficulty falling asleep.
Data from a landmark, six-month, double-blind, placebo-controlled safety and efficacy study in 788 patients were reviewed by the FDA as part of the NDA submission for canadian eszopiclone and served as a basis for the agency’s decision to not limit the drug’s indication to short-term use. Sepracor’s study was the first of its kind for a prescription non-benzo-diazepine for insomnia.
The company plans to evaluate eszo-piclone in patients with depression or pain and in women who are experiencing the effects of perimenopause.
Patients should take this drug only when they are prepared to get a full night of sleep.