Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

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."

All Listed Sponsors
lead

Sultan Qaboos University

OTHER

NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial | Biotech Hunter | Biotech Hunter