PO-57 | Early treatment with atogepant improves sleep quality without sleep-related adverse events: a prospective observational study

Alberto Boccalini,¹ Luigi Francesco Iannone,^1,2* Flavia Lo Castro,¹ Daria Brovia,¹ Marina Romozzi,^3,4 Fabrizio Vernieri,^5,6 Claudia Altamura,^5,6 Simona Guerzoni¹ | ¹Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico di Modena, Modena, Italy; ²Department of Biomedical, Metabolic, and Neural Science, University of Modena and Reggio Emilia, Modena, Italy; ³Dipartimento Universitario di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy; ⁴Neurologia, Dipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; ⁵Headache Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy; ⁶Università Campus Bio-Medico di Roma, Italy

Background: Migraine is often associated with impaired sleep quality that can exacerbate migraine severity and chronification. Calcitonin gene-related peptide (CGRP) also influences sleep regulation. While CGRP monoclonal antibodies have shown mixed effects on sleep, no study to date has evaluated the impact of gepants on sleep quality. This study assessed whether atogepant, recently approved for migraine prevention, affects sleep quality and sleep-related adverse events in real-world settings.

Methods: We conducted a prospective, observational, single-center study including 43 migraine patients (69.8% with chronic migraine). All received atogepant 60 mg/day for potentially 12 weeks. Sleep quality was assessed using five validated questionnaires (PSQI, AIS, Bergen, ESS, ISI) at baseline and at follow-up. Migraine frequency, disability (MIDAS, HIT-6), allodynia (ASC-12), acute medication use, and adverse events (AEs) were also recorded.

Results: Atogepant significantly improved sleep quality with PSQI scores decreased from 9.6 to 8.2 (p=0.002), improvements in AIS (p=0.014) and Bergen scores (p=0.046). Sleep duration was the only PSQI subdomain with a statistically significant change. No differences were found in ESS or ISI scores. Notably, no patients reported sleep-related AEs such as somnolence, nightmares, or vivid dreams. Psychiatric comorbidities were associated with poorer baseline sleep but did not influence the magnitude of improvement. Prior anti-CGRP failure predicted a lesser sleep benefit. Finally, migraine burden improved across all evaluated migraine-related variables.

Conclusion: Atogepant improved subjective sleep quality without causing sleep-related adverse events, supporting its role in comprehensive migraine management, particularly in patients with disrupted sleep.