Comparing Lemborexant, Zopiclone, and Clonidine for treating insomnia in chronic pain patients
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
This study is testing whether Lemborexant, Zopiclone, or Clonidine can help people with chronic pain sleep better and manage their pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 20 Years to 99 Years |
| Sex | All |
| Sponsor | Salem Anaesthesia Pain Clinic Academic / other |
| Locations | 1 site (Surrey, British Columbia) |
| Trial ID | NCT05618002 on ClinicalTrials.gov |
What this trial studies
This observational crossover study involves 150 adult patients with chronic pain who also suffer from insomnia. Participants will alternate between taking prescribed doses of Lemborexant, Zopiclone, or Clonidine on different nights over a three-week period. They will maintain a validated sleep diary to track their pain and sleep scores, medication usage, and any adverse effects. The study aims to evaluate the safety and efficacy of these medications in improving sleep quality and managing pain.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic pain and severe insomnia who have not responded to non-pharmacologic sleep therapies.
Not a fit: Patients with conditions such as obstructive sleep apnea, cognitive disorders, or those on high doses of opioids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective insomnia treatments for patients suffering from chronic pain.
How similar studies have performed: While there have been studies on insomnia treatments, this specific comparison of Lemborexant, Zopiclone, and Clonidine in chronic pain patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Surrey, British Columbia
- Salem Anaesthesia Pain Clinic — Surrey, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Olu Bamgbade, MD,FRCPC — Salem Anaesthesia Pain Clinic
- Study coordinator: Olu Bamgbade, MD,FRCPC
- Email: salem.painclinic@gmail.com
- Phone: +17786286600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.