Daridorexant

FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia

Retrieved on: 
Wednesday, March 10, 2021
Chemical compounds, Branches of biology, Organic compounds, Chloroarenes, Hypnotics, Sedatives, GABAA receptor positive allosteric modulators, Lactams, Orexin, Daridorexant, Insomnia, Somnolence

The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo.

Key Points: 
  • The incidence of somnolence was low and did not increase with daridorexant 50 mg compared to placebo.
  • Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analogue scale (VAS).
  • In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia.
  • Daridorexant is a dual orexin receptor antagonist (DORA) designed and developed for the treatment of insomnia.