Comparison of Lorazepam and Zolpidem effect on insomnia in bone marrow trasplantation patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2011
INTERVENTION: Intervention 1: Zolpidem, 5 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 10 mg, for 4 days. Intervention 2: Lorazepam, 1 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 4 mg for 4 days. Lorazepam, 1 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 4 mg for 4 days. Treatment ‐ Drugs Zolpidem, 5 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 10 mg, for 4 days. CONDITION: Disorders of initiating and maintaining sleep insomnia. ; Disorders of initiating and maintaining sleep PRIMARY OUTCOME: Anxiety and Depression. Timepoint: Before intervention and 4 week after beginning of intervention. Method of measurement: Hospital Anxiety and Depression Scale questionnaire. Insomnia. Timepoint: Before intervention and 1, 2, 3 and 4 weeks after beginning of intervention. Method of measurement: SleepMed Insomnia Index questionnaire. Sleepiness. Timepoint: Before intervention and 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Epworth sleepiness scale questionnaire. SECONDARY OUTCOME: Central Nervous System side effects. Timepoint: 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Clinical observation. GastroIntestinal System side effects. Timepoint: 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Clinical observation. INCLUSION CRITERIA: INCLUSION CRITERIA: Bone marrow transplantation patients that have insomnia base on the SleepMed Insomnia Index questionnaire; Patients in range of 18‐65 years old. Exclusion criteria: Sensitivity to Lorazepam or Zolpidem; Narrow‐angle glaucoma; Pregnancy & breast feeding; Hepatic encephalopathy; Rising of hepatic enzymes ( AST, ALT, ALP, LDH ) 3 times the upper limit of normal; Serum creatinine concentration more than 2.5 mg/dl; Use of alcohol; Patients who have no remission in insomnia after taking 4 mg Lorazepam or 10 mg Zolpidem during 4 days; Addiction to opioids
Epistemonikos ID: 2c646344588bd83e26b73cc69a73901ead8fb82e
First added on: Aug 22, 2024