Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
RecruitingNCT05618002
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Brief summary (from the registry)
Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.
Study details
- Official title
- Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
- Conditions
- Interventions
- Drug: Lemborexant
- Sponsor
- Salem Anaesthesia Pain Clinic
- Start date
- 2022-11-08
- Primary completion
- 2025-12-11
- Sex
- All
- Age range
- from 20 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * adult chronic pain patients * good treatment compliance * severe chronic insomnia * failure of non-pharmacologic sleep therapy * regular zopiclone therapy for 3 months or more * regular sleep diary * regular pain diary * informed consent for diary review * consent for clinical record quality assurance review Exclusion Criteria: * obstructive sleep apnoea * body mass index (BMI) ≥40 * organ insufficiency * cognitive disorder * inability to provide consent * major neuropsychiatric disorder * unreliable diary * cannabis use * regular alcohol intake * stimulant use * substance abuse * poor treatment compliance * high dose opioid * gabapentinoid use * sedative use * mild insomina * irregular zopiclone intake * regular zopiclone therapy for less than 3 months * previous adverse/allergic reactions to clonidine or zopiclone
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Salem Anaesthesia Pain Clinic | Surrey | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05618002