Long-term usefulness of Daridorexant in patients with insomnia

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Created On: 21/02/2023

Daridorexant enhanced sleep and daytime functioning in two phase III, 12-week studies of patients affected with insomnia condition while retaining a positive safety profile. This 40-week extension study's goal was to assess Daridorexant's long-term safety and tolerability.

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Key take away

In adults, 50 mg Daridorexant is beneficial for the long-term management of insomnia, without any signs of rebound, tolerance, or physical dependence.

Background

Method

This double-blind extension trial included all adult patients with insomnia disorder who had successfully completed the 12-week studies. Participants who were initially assigned to receive Daridorexant (10 mg, 25 mg, or 50 mg) continued to receive those doses. On the other hand, participants who were initially allocated to receive placebo were re-assigned to receive Daridorexant 25 mg or placebo.

There was a 7-day run-out for the placebo after the 40-week treatment period. The key endpoint was to determine tolerability and safety. Determination of Daridorexant's effectiveness on daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire) and sleep (self-reported total sleep time) were the exploratory goals.

Result

The trial included a total of 804 individuals, of whom 801 were administered at least one dose of the experimental therapy. Of these, 550 patients (68.4%) finished the study. Treatment-emergent adverse effects incidence was comparable between the groups (35–40%). Following the end of the treatment, there were no rebound symptoms, no next-morning sleepiness, or withdrawal-associated symptoms triggered by the use of Daridorexant.

The dose of Daridorexant that produced the most apparent improvements in daytime performance and sleep was 50 mg. At weeks 12, 24, and 36 of the extension trial, the highest dose of Daridorexant raised self-reported total sleep time by a least-squares mean of 20.4, 15.8, and 17.8 minutes and minimized Insomnia Daytime Symptoms and Impacts Questionnaire total scores by least-squares mean of − 9.3, − 9.5, and − 9.1 respectively. Daridorexant's effects were most optimal with the highest approved dose of 50 mg. No novel safety signals were noted.

Conclusion

Daridorexant, a dual orexin receptor antagonist, is typically well-tolerated and safe for use at all doses for up to 12 months. Exploratory efficacy assessments indicated that 50 mg Daridorexant is safe to use for the long-term management of insomnia owing to the sustained improvements in sleep and daytime functioning it elicits.