Daridorexant treatment in adults with migraine and insomnia: an exploratory study of sleep and headache outcomes
Exploratory Study Evaluating Nightly Daridorexant in Patients with Chronic Migraine and Comorbid Insomnia
Vivek Milan Keshani at Sunnybrook Hopsital, Toronto, Ontario
25 participants
Feb 16, 2026
Interventional
Conditions
Summary
This study is designed to explore whether treatment with Daridorexant, a sleep medication, can improve sleep quality and reduce migraine-related disability in adults who experience both migraine and insomnia. Participants will take Daridorexant 50 mg once daily at bedtime for 12 weeks. The study will assess changes in sleep, headache burden, and overall patient-reported improvement. We hypothesize that Daridorexant will lead to better sleep and a reduction in the impact of migraines on daily functioning.
Eligibility
Inclusion Criteria4
- Adults aged 18 to 70 years of age
- Diagnosis of high-frequency episodic migraine or chronic migraine according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria
- Comorbid chronic insomnia as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3)
- Stable preventive migraine medication regimen in the 30 days before enrollment
Exclusion Criteria7
- Presence of other primary sleep disorders confirmed by polysomnography or via clinical history
- Free from serious medical or psychiatric disease. Among the excluded medical conditions were liver impairment (Child-Pugh class B and higher), and hypersomnia disorders such as narcolepsy, idiopathic hypersomnia, or hypersomnia due to other medical conditions not otherwise specified (NOS). Exclusion of participants with co-morbid Major depressive disorder, Generalized anxiety disorder, psychosis, and substance abuse disorder.
- Alternative headache diagnosis
- Planned changes to the current preventive migraine medications during the study
- Pregnancy and breastfeeding
- Participants will be excluded if they have any known contraindication to Daridorexant, are currently taking medications with known clinically Significant interactions with Daridorexant, have previously been treated with Daridorexant, or are using any other dual orexin receptor antagonist (DORA) concurrently.
- Patients with daily or continuous headaches
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Interventions
Brief name: Daridorexant (International Non-proprietary Name) Intervention description: Participants in this single-arm pilot study will receive Daridorexant 50 mg oral tablets, administered once daily at bedtime for 12 weeks. The intervention is fixed-dose.. Tablets will be dispensed by the Principal Investigator or Co-Investigator from a secure storage location at Sunnybrook Hospital. -Mode of administration: Oral tablet, taken at home by participants. -Duration: 12 weeks of continuous treatment. Adherence/fidelity: Adherence will be assessed through participant self-report, pill counts, and drug accountability logs maintained by the research coordinator. Strategies to maintain fidelity include clear participant instructions, reminder calls/texts, and review of medication use at each study visit.
Locations(1)
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ACTRN12626000081314