Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Last updated: January 23, 2025
Sponsor: Salem Anaesthesia Pain Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Insomnia

Restless Leg Syndrome

Treatment

Lemborexant

Clinical Study ID

NCT05618002
SalemAnaesth2022 LemborexZop
  • Ages 20-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Lemborexant
Phase:
Study Start date:
November 08, 2022
Estimated Completion Date:
December 11, 2025

Study Description

Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain.

Methods: 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. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Connect with a study center

  • Salem Anaesthesia Pain Clinic

    Surrey, British Columbia V3S 7J1
    Canada

    Active - Recruiting

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