Insomnia is defined in the DSM-5® as a predominant complaint of dissatisfaction with sleep quantity or quality with one (or more) of the following symptoms: (i) difficulty initiating sleep, (ii) difficulty maintaining sleep characterized by frequent awakenings or problems returning to sleep after awakenings, and (iii) early-morning awakening with inability to return to sleep. Sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. In April 2022, the European Commission approved QUVIVIQ (daridorexant).
This dual orexin receptor antagonist (DORA) is a new option for the treatment of adult patients with insomnia characterized by symptoms present for at least 3 nights per week and for at least 3 months and considerable impact on daytime functioning. In May 2023, in recognition of the new treatment option provided by QUVIVIQ, the French National Authority for Health (Haute Autorité de Santé HAS) issued a favorable decision on its reimbursement in France, including a request for additional real-world data, to be provided.
In this context, the marketing-authorization holder, Idorsia France implements a study to describe the QUVIVIQ conditions of use and prescription modalities, and to assess the effectiveness over time of QUVIVIQ, on the insomnia severity and patient quality of life, in the standard clinical setting. This is a post-authorization, observational, prospective, longitudinal, multicenter single cohort study conducted in standard clinical setting, among general practitioners, psychiatrists and sleep centers in France.
Patients will be followed for a maximum of 12 months or until QUVIVIQ discontinuation (whichever comes first) with 4 evaluation points (1 month, 3, 6, and 12 months). The overall study period is approximately 3 years. Data will be collected from investigators and patients with online questionnaires.