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Abstract Introduction Daridorexant was approved by FDA and EMA for the treatment of chronic insomnia. It is a new dual orexin-receptor anatgonist, which demonstrated its clinical efficacy and safety in randomized controlled trials. The real-world data including its influence on the health-related quality of life (HrQol) are not yet available. In this prospective observational study we investigate the influence of daridorexant on HrQol in patients with chronic insomnia. Methods Patients with chronic insomnia diagnosed following the DSM V criteria were included in the observational study in terms of the Mainz Sleep Registry (MAINZ-SLEEPREG). All patients received the standard dosis of daridorexant of 50mg/night. The evaluation of clinical parameters and HrQoL was performed before, as well as three and six months after the initiation of daridorexant. The collected night-time efficacy endpoints included wake time after sleep onset (WASO), latency to persistent sleep (LPS), total sleep time and self-reported total sleep time. The EuroQol5D (EQ5D Index and EQVAS: visual analogue scale) was used to evaluate HrQol. Results Study participants (n=63) were 52.7±11.0 years old and 58.7% of them were females. All applied night-time efficacy measures (WASO, LPF, total sleep and self-reported sleep time) showed a significant improvement by approximately 20-40% at the time points after three and six months (p 0.05). At the follow-up after three and six months the EQ5D Index values (0.71±0.17 and 0.72±0.15, correspondingly) improved on daridorexant by 18% in comparison to baseline (0.61±0.17, p 0.05). Similar increase of HrQol was observed on EQVAS (62.2±16.5 at baseline versus 73.9±19.8 and 74.6±18.9, p 0.05). Conclusion The data from this real-word study shows that daridorexant not only significantly improves the night-time sleep of patients with chronic insomnia but it also increases their HrQol. These findings encourage farther real-world studies to investigate the role of daridorexant in the treatment of chronic insomnia in broader populations. Support (if any)
Winter et al. (Sat,) studied this question.