CompletedNot Applicable

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada

Canada90 participantsStarted 2024-06-20

Plain-language summary

The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed ICF prior to any study-mandated procedure. * Has received a first prescription of daridorexant 50 mg to treat insomnia, treatment start has not exceeded 7 days prior to enrollment. * Ability to read and understand French or English. Exclusion Criteria: * Patients participating in a clinical trial. * History of daridorexant use in the past (i.e., samples provided by the physician before prescription). * Taking a concomitant medication to treat insomnia. * Already started daridorexant more than 7 days prior to enrollment.The 7-day period is necessary to allow flexibility between the time of prescription and PROxy first contact to participant. Beyond this 7-day period, patients may already have experienced benefits from daridorexant. To minimize bias in baseline results, these patients will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study already completed — does that mean results are available, and if so, what did people with insomnia actually report about their sleep quality and daily functioning after taking daridorexant?
2Since this was an observational study rather than a randomized controlled trial, how much confidence can we have in what it found about daridorexant's effects on insomnia severity and quality of life?
3The study tracked work productivity loss as a key outcome — given my own situation with work or daily responsibilities, do you think daridorexant's real-world profile makes it a reasonable option to consider for me?
4Are there standard insomnia treatments — like cognitive behavioral therapy for insomnia or other medications — that you'd recommend I try before or alongside anything suggested by this kind of real-world data on daridorexant?
5Since this study was done in Canada and focused on real-world patients rather than a controlled setting, does the evidence it generated apply to someone with my specific health history and insomnia pattern?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Quality of Life

Timeframe: Month 1, Month 2, Month 3

Change from Baseline in Work Productivity Loss

Timeframe: Month 1, Month 2, Month 3

Change from Baseline in the Severity of Insomnia Symptoms

Timeframe: Month 1, Month 2, Month 3

Trial details

NCT IDNCT06311864

SponsorPeriPharm

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-19

View on ClinicalTrials.gov More Insomnia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.