• Daridorexant
• DORA
• Insomnia
• Insomnia treatment
• Meta-analysis

Insomnia is a common sleep disorder and in its chronic form has important consequences on the individual's quality of life, as well as being a risk factor for several health conditions. Although cognitive-behavioral therapy (CBT-I) is the recommended first-line treatment, a pharmacological approach is often necessary. However, pharmacological treatment for insomnia proves inadequate in the long term, losing effectiveness, manifesting phenomena of tolerance, abuse or rebound insomnia. Daridorexant is a new drug, recently approved, belonging to the class of DORA (Dual Orexin Receptor Antagonists), which acts on the orexin system, a key system in the sleep-wakefulness regulation. Daridorexant has proven to be effective and safe in the long run, without showing those disadvantages of other drugs typically used for insomnia.
We conducted a meta-analysis to quantitatively summarize and synthesize the findings from individual studies published so far. Furthermore, we also attempted to identify potential moderators or mediators of treatment response, such as dosage and duration of treatment, providing a more robust and comprehensive evaluation of the effectiveness of daridorexant on sleep-related parameters.
Furthermore, we conducted a study that aimed to assess the effectiveness of daridorexant (50 mg) in improving sleep parameters in patients with insomnia disorder. Both at T0 (baseline) and T1 (after 1 month of daily intake), participants were invited to fill out validated questionnaires and information about subjective sleep parameters (LPS, TST, WASO) was collected. Additionally, a subgroup, underwent a 7-day actigraphic monitoring. We then analyzed the data collected at T0 and T1, assessing the effectiveness of daridorexant after 1 month and evaluating potential predictors of a better treatment response. These data also contributed to a power estimation analysis that may pave the way to framing future studies.