Drug updated on 10/24/2024
Dosage Form | Tablets (oral; 25 mg, 50 mg) |
Drug Class | Orexin receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance
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Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Daridorexant significantly reduces polysomnography-derived Wake After Sleep Onset (WASO) at doses of 10 mg and 50 mg, with 50 mg demonstrating the most notable reduction compared to placebo.
- Daridorexant at doses of 25 mg and 50 mg significantly improves Latency to Persistent Sleep (LPS) compared to placebo, with 50 mg being the most effective.
- Self-reported Total Sleep Time (TST) is significantly increased with daridorexant at doses of 25 mg and 50 mg compared to placebo, showing higher effectiveness than other dual orexin receptor antagonists (DORAs), except for the 5 mg dose.
- There is no significant dose-response relationship for total adverse events (AEs) with daridorexant, and the incidence of AEs is generally low across all doses.
- Serious adverse events (SAEs) are comparable to placebo for both 25 mg and 50 mg doses, with no significant differences reported between daridorexant and placebo.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Quviviq (daridorexant) Prescribing Information. | 2023 | Idorsia Pharmaceuticals US Inc., Radnor, PA |