Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials
These two RCTs (n=930 & n=924) of this novel orexin receptor antagonist, provide evidence of its efficacy on objective sleep induction and maintenance, on patient-reported sleep quantity and quality, and (at dose of 50 mg) on daytime functioning, with favourable safety profile.
Source:
The Lancet Neurology
SPS commentary:
The researchers acknowledge these studies also had limitations, such as the population studied, use of the novel IDSIQ instrument, and the 3-month duration of the studies might not have been long enough to capture the maximal or long-term effects of daridorexant.
According to a commentary, because of the selection of outcome measures, it is difficult to compare daridorexant with other treatments for insomnia, such as CBT, which is recommended as first-line treatment in clinical guidelines. It notes the primary outcomes of the daridorexant trials were objective sleep parameters measured by polysomnography and only modest differences were reported for (subjectively defined) insomnia severity, as determined with the Insomnia Severity Index (ISI), and in fact, daridorexant out-performed placebo by less than 2 points on the ISI in both reported trials, questioning the clinical importance of the study findings from the patients’ perspective. It suggests nevertheless that the findings support daridorexant as a viable treatment for patients with insomnia disorder, but future studies should provide essential data not only on long-term effects, but also on the effects on patient-centred outcomes that are directly related to the core symptoms of insomnia. It adds that more work is also needed to establish how daridorexant will fit within current treatment pathways.