Daridorexant (2) – Quviviq®

• 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.