Daridorexant: a breakthrough for insomnia treatment in Europe?

Diego Garcia-Borreguero, MD, PhD, Sleep Research Institute, Madrid, Spain, talks of the implications of the positive Phase III trials of daridorexant, a novel dual orexin receptor antagonist (DORAs), for the treatment of insomnia. Two pivotal Phase III studies investigating the safety and efficacy of daridorexant at four dose levels found a significant dose-response relationship, with 50mg shown to be effective for reducing latency to persistent sleep, reducing wake after sleep onset, and improving daytime functioning. Idorsia has submitted for EMA and FDA approval for daridorexant. While two DORAs are currently approved by the FDA for use in the US, neither are approved in Europe, meaning daridorexant may represent a breakthrough in the region. Prof. Garcia-Borreguero highlights the limitations of currently available GABAergic agents and cognitive behavioral therapies that this new class of drugs could overcome. This interview took place at the European College of Neuropsychopharmacology congress 2021.