ECNP 2021 | Dual orexin receptor antagonists – the story so far and daridorexant Phase III data

5 noviembre 2021

For many years, GABAergic agents were the only pharmacological treatments available for patients with insomnia. Benzodiazepines and benzodiazepine receptor agonists are often used to treat insomnia, demonstrating short-term benefits on sleep onset latency and duration. However, pharmacological tolerance and cognitive side effects, amongst other associated harms, prevent their use long term. More recently, dual orexin (also known as hypocretin) receptor antagonists (DORAs) have emerged as a new treatment approach for patients with insomnia. Diego Garcia-Borreguero, MD, PhD, Sleep Research Institute, Madrid, Spain, discusses the role of orexin in sleep physiology and the development of DORAs to date. Daridorexant, a new DORA, is currently under investigation. Prof. Garcia-Borreguero outlines the findings of Phase II program and recently published Phase III trial results. The Phase 3 registration program (NCT03545191, NCT03575104) comprises two 3-month confirmatory studies, with an additional 40-week extension period, which recruited around 1,800 patients with insomnia. Data demonstrated that 50mg daridorexant was effective for treating sleep onset insomnia, reducing latency to persistent sleep and wake after sleep onset. This interview took place at the European College of Neuropsychopharmacology congress 2021.