Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.

ABSTRACT:

Background and objective

Daridorexant is a dual orexin receptor antagonist for the treatment of insomnia. In two phase III, 12-week studies in patients with insomnia disorder, daridorexant improved sleep and daytime functioning while maintaining a favorable safety profile. The objective of this 40-week extension study was to assess the long-term safety and tolerability of daridorexant.

Methods

Adults with insomnia disorder who completed the 12-week studies were invited to enroll in this double-blind extension study. Patients originally randomised to daridorexant (10 mg/25 mg/50 mg) remained on their respective treatments; patients randomised to placebo were re-randomised to daridorexant 25 mg or placebo. The 40-week treatment period was followed by a 7-day placebo run-out. T

SUBMITTER: Kunz D 

PROVIDER: S-EPMC9829592 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature