Quviviq
Psychiatry· 1352 cited findings· 2 source documents
Company: Idorsia Ltd
What the regulatory reviews say
Quviviq (daridorexant) is approved for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approved dosage is 25 mg to 50 mg taken orally no more than once per night within 30 minutes of going to bed, with at least 7 hours remaining prior to planned awakening.
Primary efficacy endpoints included wake after sleep onset (WASO) and latency to persistent sleep (LPS). Statistically significant treatment effects for WASO were observed at Month 1 and Month 3 for the 25-mg and 50-mg doses in Trial ID-078A301, and for the 25-mg dose in ID-078A302. LPS showed statistically significant treatment effects at Month 1 and Month 3 for both doses in Trial ID-078A301. Statistically significant treatment effects for sTST were observed for the 25 mg dose in Trial ID-078A302 and the 25 mg and 50 mg doses in Trial ID-078A301. The IDSIQ sleepiness domain showed a statistically significant treatment effect for the 50 mg dose in Trial ID-078A301.
Safety findings included sleep paralysis (less than 1% with 50 mg), hypnogogic or hypnopompic hallucinations (less than 1% with 25 mg), and depressive symptoms (1 to 2% with daridorexant vs. less than 1% with placebo). Post-marketing requirements include assessing effects on balance and cognition after arousal, conducting a pregnancy exposure registry, and a clinical lactation study.
Key figures — cited to the source page
| WASO change from baseline (LS mean difference vs placebo) | -22.78 | Idorsia Ltd — Quviviq FDA Review, p.62 |
| LPS change from baseline (LS mean difference vs placebo) | -11.67 | Idorsia Ltd — Quviviq FDA Review, p.62 |
| sTST change from baseline (LS mean difference vs placebo) | 22.05 | Idorsia Ltd — Quviviq FDA Review, p.63 |
| Depressive symptoms in patients taking daridorexant | 1 to 2% | Idorsia Ltd — Quviviq FDA Review, p.27 |
| Depressive symptoms in patients taking placebo | less than 1% | Idorsia Ltd — Quviviq FDA Review, p.27 |
| Sleep paralysis in subjects treated with 50 mg | less than 1% | Idorsia Ltd — Quviviq FDA Review, p.27 |
| Approved dosage | 25 mg to 50 mg | Idorsia Ltd — Quviviq FDA Review, p.2 |
| Approved SNOMED term for indication | 193462001 | Idorsia Ltd — Quviviq FDA Review, p.2 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.