Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

Summary

The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.

Conditions

• Depressive Disorder, Major

Interventions

DRUG

Tizanidine Hcl 4Mg Tab

Initial Dose Administration: Patients will start by taking an initial dose of 2 mg of Tizanidine at bedtime (HS). Dose Titration Process: Every 4 days, the dose of Tizanidine will be increased by 2 mg. This titration is based on the patient's response to the medication and their tolerability of it. Maximum Dose Limit: The dose titration will continue until reaching the maximum dose of 0.1 mg/kg/HS, or until the maximum tolerated dose is identified, whichever comes first. Monitoring and Adjustment: Throughout the titration process, patients will be closely monitored for any adverse effects and for the effectiveness of the medication. Adjustments to the dosing schedule may be made based on the clinician's assessment of tolerability and therapeutic response.

DRUG

Zolpidem Tartrate 10 mg

nitial Dose Administration: Participants will start by taking an initial dose of Zolpidem 5 mg orally at home before bedtime (HS). Response Evaluation and Dose Adjustment: If there is no response to the initial 5 mg dose and it is tolerated well by the participant, the dose will be increased to 10 mg. Monitoring and Adjustment: Participants will be monitored for their response to the medication as well as for any adverse effects. The decision to increase the dose to 10 mg will be based on the absence of a therapeutic response to the initial dose and the participant's tolerability of Zolpidem. Dose Maximization and Safety: The increase to a 10 mg dose is aimed at maximizing therapeutic efficacy while ensuring the safety and tolerability of the medication in participants who do not respond to the lower dose.

Sponsors & Collaborators

• Sultan Qaboos University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-30

Primary Completion

2026-09-30

Completion

2026-12-31