Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration

Background: The dual orexin receptor antagonist ACT-541468 showed sedative pharmacodynamic effects during initial clinical testing in adult subjects. The present study explored pharmacokinetics, pharmacodynamics and tolerability in healthy elderly subjects. Methods: Double-blind, placebo-controlled, randomised, single-ascending dose study in 24 male/female elderly (65–80 years, 5, 15 and 25 mg in the morning, 6/2 active/placebo per group)....