Summary

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• Quviviq (daridorexant) is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
• This summary is based on the review of nine systematic review(s)/meta-analysis(es). ^[1-9]
• Latency to Persistent Sleep (LPS): Daridorexant significantly reduced LPS with a mean difference (MD) of -7.23 minutes compared to placebo (95% CI, -9.60 to -4.85; P < 0.00001). No clear superiority was noted between daridorexant and suvorexant.
• Wake Time After Sleep Onset (WASO): Daridorexant significantly reduced WASO with MD = -13.26 minutes (95% CI, -15.48 to -11.03; P < 0.00001). Lemborexant 5 mg demonstrated the highest efficacy in subjective WASO (sWASO), with daridorexant also showing significant improvement.
• Total Sleep Time (TST): Daridorexant increased TST with an MD of 14.80 minutes (95% CI, 11.18-18.42; P < 0.00001), with consistent and robust efficacy, comparable to suvorexant and lemborexant.
• Daridorexant exhibited a slightly higher incidence of treatment-emergent adverse events (TEAEs) compared to placebo, with a risk ratio (RR) of 1.19 (95% CI, 1.05-1.35; P = 0.005), including specific adverse events like somnolence (RR = 1.19) and fatigue (RR = 2.01).
• Daridorexant showed no significant difference in serious adverse events (SAEs) compared to placebo for both 25 mg (RR = 0.86) and 50 mg (RR = 1.32). Narcolepsy-like symptoms, such as excessive daytime sleepiness (RR = 2.15) and sleep paralysis (RR = 3.40), were reported with an increased risk.
• Population Types and Subgroup Considerations: Daridorexant is effective across the general adult population with insomnia, showing consistent pharmacokinetics and pharmacodynamics regardless of sex, age, race, body size, or mild-to-moderate kidney impairment. Dose adjustment is necessary for moderate liver impairment, and severe liver impairment is a contraindication. No significant differences in effectiveness or safety were observed across these subgroups compared to other DORAs.