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Lunesta Approval History

  • FDA approved: Yes (First approved December 15th, 2004)
  • Brand name: Lunesta
  • Generic name: eszopiclone
  • Dosage form: Tablets
  • Previous name: Estorra
  • Company: Sepracor Inc.
  • Treatment for: Insomnia

Lunesta (eszopiclone) is a nonbenzodiazepine hypnotic agent indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).

Development History and FDA Approval Process for Lunesta

Dec 15, 2004Approval Lunesta Sepracor Inc. - Treatment for Insomnia
Jul 15, 2004Sepracor Announces FDA Acceptance of Estorra NDA Resubmission and Issuance of Class 2 Review Designation
Jun 16, 2004Sepracor Announces Resubmission of Estorra NDA to FDA
Mar  1, 2004Sepracor Announces Approvable Action for Estorra (eszopiclone) for the Treatment of Insomnia and Provides Update on Launch Plans

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