Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

Launched by SULTAN QABOOS UNIVERSITY · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare two medications, Tizanidine and Zolpidem, to see which one helps improve sleep quality in adults with primary insomnia. Primary insomnia is a condition where people have trouble sleeping but do not have another medical or psychiatric problem causing it. The study will enroll adults aged 18 to 60 who have been diagnosed with primary insomnia. Participants will need to be able to give their consent and follow study guidelines, including a medical checkup before starting the trial.

During the trial, participants will be randomly assigned to receive either Tizanidine or Zolpidem for 12 weeks. Researchers will regularly assess their sleep quality and any side effects they experience. The study aims to gather information that can help doctors choose the best treatment for individuals struggling with sleep issues. It's important to note that participants should not have used sleep medications or certain substances that affect sleep in the month before joining the study. The trial is not yet recruiting participants, but it promises valuable insights into managing insomnia.

Gender

ALL

Eligibility criteria

• 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.