Title:Daridorexant and Insomnia in Clinical Practice: A Nominal Group Technique Consensus Study among Italian Sleep and Insomnia Experts
Volume: 24
Issue: 1
Author(s): Luigi Ferini-Strambi, Dario Arnaldi, Enrica Bonanni, Alessandro Cicolin, Gian Luigi Gigli, Claudio Liguori, Carolina Lombardi, Liborio Parrino, Federica Provini, Monica Puligheddu, Andrea Romigi, Rosalia Silvestri and Laura Palagini*
Affiliation:
- Department of Neuroscience, Psychiatric Section, Azienda
Ospedaliera Universitaria Pisana (AUOP), Pisa, Italy
Keywords:
Insomnia, daridorexant, orexin, DORA, chronic insomnia disorder, sleep health, insomnia treatment.
Abstract:
Introduction: Chronic insomnia disorder significantly affects cognitive, emotional, and
physical health. Recently, the dual orexin receptor antagonist (DORA) daridorexant was approved for
treating chronic insomnia in several countries. Given the limited evidence available, expert consensus
was sought to clarify key clinical issues, inform practice, and guide future research.
Methods: Thirteen Italian sleep experts employed the Nominal Group Technique (NGT) to identify
and rank important clinical questions. The process involved independent thought generation, group
discussion, and online voting using a 5-point Likert scale.
Results: The NGT process resulted in 55 statements across five key clinical questions, with relevance
scores guiding their categorization into three tiers. Key findings highlight daridorexant’s mechanism of
action, safety profile, efficacy on night and day parameters, and suitability for long-term use. The experts
emphasized cross-tapering strategies for switching from other hypnotics, the importance of sleep psychoeducation,
and using the Insomnia Severity Index and sleep diaries for treatment evaluation.
Discussion: Daridorexant may address insomnia without increasing sedation via its dual orexin receptor
antagonism. Daridorexant seems to be effective and safe even in special patient populations,
such as the elderly and those with comorbid conditions (neurodegenerative disorders and cognitive
impairment, comorbid insomnia and sleep apnea, psychiatric conditions and mood disorders, epilepsy,
and restless leg syndrome), thus representing a new, promising option for insomnia treatment.
Conclusion: The expert consensus provides a comprehensive framework for daridorexant clinical
application, advocating for further research to expand the evidence base and refine best practices, as
well as underscoring the importance of a multidisciplinary approach that combines both pharmacological
and psychosocial interventions to optimize outcomes.
