Skip to Content

Belsomra Approval History

  • FDA approved: Yes (First approved August 13th, 2014)
  • Brand name: Belsomra
  • Generic name: suvorexant
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • Treatment for: Insomnia

Belsomra (suvorexant) is an orexin receptor antagonist for use in patients with difficulty falling or staying asleep (insomnia).

Development History and FDA Approval Process for Belsomra

Aug 13, 2014Approval FDA Approves Belsomra (suvorexant) for Insomnia
Jul  1, 2013Merck Receives Complete Response Letter for Suvorexant, Merck‚Äôs Investigational Medicine for Insomnia
May 22, 2013Merck Statement on FDA Advisory Committee Meeting for Suvorexant
Nov  8, 2012Merck Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.