Daridorexant (2) – Quviviq®
Sleep disorders
Characteristics
| Start date | 01.03.2024 – Marketing authorisation: 29.04.2022 |
|---|---|
| Resolution | 15.08.2024 |
| INN | Daridorexant |
| Brand name | Quviviq® |
| Pharm. company |
Dossier: Idorsia Pharmaceuticals Germany GmbH
New distributor: Idorsia & Berlin-Chemie |
| G-BA Procedure ID | D-1047 |
| ATC code | N05CJ03 HYPNOTICS AND SEDATIVES (N05C) |
| ICD-10 codes (AIS) | F51.0Insomnia not due to a substance or known physiological condition |
| Alpha-ID codes (AIS) | I3067Non-organic insomnia |
| Therapeutic area | Nervous system diseases Sleep disorders / Insomnia / Excessive daytime sleepiness (EDS) |
| Reason for procedure |
Reassessment: §13 (G-BA request)
Original resolution: Daridorexant (1) (12.05.2023) |
| Therapeutic indication of the resolution |
|---|
|
Quviviq is used to treat adults with sleep disorders (insomnia) whose symptoms have persisted for at least 3 months and have a significant impact on daytime activity. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with sleep disorders (insomnia) whose symptoms have persisted for at least 3 months and have a significant impact on daytime activity | Best Supportive Care |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (Studie 301) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- Study 301 was a double-blind, randomised, controlled trial comparing daridorexant with placebo in adults with a chronic sleep disorder of at least moderate severity and insufficient sleep duration.
- Study 303 is an extension study of Study 301 and comprises a 40-week double-blind treatment phase, followed by a placebo run-out phase and a 23-day follow-up period.
Adults with sleep disorders (insomnia) whose symptoms have persisted for at least 3 months and have a considerable impact on daytime functioning
- For adults with sleep disorders (insomnia) whose symptoms have persisted for at least 3 months and have a considerable impact on daytime activity, the additional benefit is not proven.
- The additional benefit of daridorexant compared with the appropriate comparator therapy for adults with sleep disorders (insomnia) whose symptoms have persisted for at least 3 months and have a significant impact on daytime activity is not proven.
- Overall assessment
- In summary, there are therefore no suitable data available for benefit assessment of daridorexant.
Courtesy translation only, please refer to the German original.
Associated procedures
| Daridorexant (2) | Quviviq® | Idorsia Pharmaceuticals Germany GmbH | Sleep disorders | 8,300–218,500 | 100% additional benefit not proven | |
| Daridorexant (1) | Quviviq® | Idorsia Pharmaceuticals Germany GmbH | Sleep disorders (mental illnesses) |
0
1,900–79,000 |
100% additional benefit not proven repealed |
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