Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial
Status: Not yet recruiting

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age and Gender Adult participants of either gender, aged 18-60 years old. Diagnosis: Diagnosed with primary insomnia by a psychiatry specialist, based on DSM-5 criteria. Consent: Able to provide written informed consent. Compliance: Willing to comply with study procedures and follow-up assessments. Medical Clearance: Participants must undergo a medical checkup by a medical officer affiliated with Al-Masarah Hospital before the randomization process. This checkup includes: Medical history review. Physical examination, including ECG. Vital signs check. Random blood sugar test. Laboratory evaluation (CBC, LFT, RFT, TFT, Lipid profile). Enrollment: Receiving medical clearance for enrollment in the study.  Exclusion Criteria:  Secondary Insomnia: Individuals diagnosed with secondary insomnia. Substance Abuse History: Those with a history of substance abuse. Significant Medical or Psychiatric Disorders: Individuals diagnosed with significant and/or unstable medical or psychiatric disorders or mental retardation. Pregnancy or Lactation: Pregnant or lactating mothers, or those of childbearing potential not using an adequate method of contraception (excluding natural birth spacing methods). Drug Allergy: Known hypersensitivity or allergy to Tinazidine or Benzodiazepines. Communication Barriers: Individuals unable to understand or communicate with researchers. Recent Participation in Clinical Trials: Those who have participated in other clinical trials involving investigational drugs within the past 30 days before participation. Recent Use of Sleep Medication: Participants must not have taken any over-the-counter or prescription sleep medication within the past 30 days before participation. Use of Substances Affecting CNS: No intake of any substance with central nervous system (CNS) effects known to affect sleep within 30 days before participation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult