Drug updated on 4/18/2024
| 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.
Summary
- Daridorexant (Quviviq) is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. It has a slightly higher incidence of adverse events such as somnolence and fatigue compared to placebo, but serious adverse events are comparable, suggesting a generally favorable safety profile.
- Nine systematic reviews/meta-analyses provided insights into daridorexant's comparative safety, efficacy, and considerations across different populations.
- Compared to other FDA-approved Dual Orexin Receptor Antagonists like suvorexant and lemborexant, daridorexant shows similar trends in terms of increased risk for treatment-emergent adverse events. The group exhibited significantly higher risks of Excessive Daytime Sleepiness (EDS) and sleep paralysis compared to placebo.
- Daridorexant demonstrated superior effectiveness over placebos in reducing wake time after sleep onset latency to persistent sleep while increasing total sleeping time. Compared to suvorexant or lemborexant at varying doses, it was found that all studied drugs except for the minimum dose version were more effective than placebos when considering wake times post-sleeping onset.
- Pharmacokinetic parameters did not differ significantly among sexes, ages, races, body sizes, or in individuals with mild-to-moderate kidney impairment, making this drug versatile across various patient profiles. However, its use necessitates dosage limitation among individuals suffering from moderate liver impairments due to its hepatic CYP3A4 metabolism process being affected by these conditions.
- Despite some associated risks such as narcolepsy-like symptoms, including excessive daytime drowsiness or even instances where users experience a temporary inability to move or speak upon waking up from a deep REM stage slumber period, daridorexant overall presents as an effective agent particularly useful in treating those who have difficulty maintaining their nightly rest cycles without causing significant disruptions during their day-to-day activities.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Quviviq (daridorexant) prescribing information. | 2023 | Idorsia Pharmaceuticals US Inc., Radnor, PA |