Daridorexant (1) – Quviviq®

• Clinical trials
  • The pharmaceutical manufacturer presents the results of Study 201. This is a double-blind, randomised study with the following treatment arms: daridorexant (dosage relevant to the benefit assessment: 50 mg/day; n = 61), zolpidem (10 mg/day; n = 60) and placebo (not relevant), which was conducted at 38 centres in Germany, Israel, Spain, Sweden, Hungary and the USA.
  • In addition, the pharmaceutical manufacturer has submitted an evidence transfer for adults aged ≥ 65 years based on Study 201 and Study 301, in which daridorexant was compared with placebo.

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.
• mortality
  • No deaths occurred in the study.
• morbidity
  • Polysomnography Here, a statistically significant difference was observed between the treatment groups in the total duration of wakefulness following the onset of sleep; however, the clinical relevance of this finding remains unclear.
• quality of life
  • Health-related quality of life was not assessed in the study.
• Side effects
  • For the endpoints of severe adverse events and discontinuation due to adverse events, no statistically significant difference was observed between the treatment groups in either case.
• Overall assessment
  • Study 201 provides results on endpoints in the categories of mortality, morbidity and side effects, comparing daridorexant with zolpidem. In terms of mortality and side effects, there was no statistically significant difference between the treatment groups in either case. This also applies to the patient-relevant endpoints of morbidity, which were recorded using a sleep diary. Statistically significant differences in favour of daridorexant in patient-reported and polysomnographically recorded parameters relating to sleep quantity cannot be taken into account due to their unclear relevance to patients and because they are not reflected in the sleep quality parameters.
  • Overall, there are therefore no differences between daridorexant and the appropriate comparator therapy that are relevant for the benefit assessment. The additional benefit of daridorexant is therefore not proven.

Courtesy translation only, please refer to the German original.