Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

Salem Anaesthesia Pain Clinic

Status: Completed

Conditions: Pain, Chronic; Insomnia Chronic

Treatments: Drug: Zopiclone 7.5mg pill; Drug: Zopiclone 3.75mg pill; Drug: Clonidine 0.2mg pill; Drug: Clonidine 0.1mg pill

Study type: Observational

Funder types: Other

Identifiers

NCT05277038

SalemAnaesth 2021 ClonZop

Details and patient eligibility

About

A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.

Full description

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

Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were 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 was considered significant.

Enrollment: 150 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Clonidine vs Zopiclone for insomnia

Description:

Consecutive adult patients who underwent pain management at a Canadian pain clinic. The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose). They were advised to take either clonidine or zopiclone on alternate nights. For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations. The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1. The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg. Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks. Therefore, each of the four medication doses was used five times by each patient.

Treatment:

Drug: Clonidine 0.1mg pill

Drug: Zopiclone 3.75mg pill

Drug: Clonidine 0.2mg pill

Drug: Zopiclone 7.5mg pill