Daridorexant: what did the insomnia trial show?
Two randomized trials enrolled 930 and 924 adults. Daridorexant 50/25 mg or 25/10 mg, respectively, was compared with placebo each evening for three months.
In trial 1, 50 mg reduced overnight wakefulness by 18.3 minutes and time to persistent sleep by 11.7 minutes versus placebo at month three. Daytime sleepiness, a secondary outcome, also improved. The 10 mg group did not meet the reported efficacy tests; 25 mg did not significantly improve daytime sleepiness.
Adverse-event rates were broadly similar; headache and nasopharyngitis were common. One death was judged unrelated to treatment. Three-month, sponsor-funded trials do not establish comparative superiority over other sleep medicines.
These results apply to the studied population, formulation and follow-up.
What might this mean, and what would change the interpretation?
This is a selected trial summary, not a full literature review or formal quality appraisal.
What would clarify this: Further studies of long-term outcomes and different patient groups.
Findings reviewed · abstract
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.