insomnia. Disorders of initiating and maintaining sleep
Conditions
Interventions
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
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.
Lorazepam, 1 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 4 mg for 4 days.
Sponsors
Vice chancellor for research,Faculty of pharmcy, Shaheed Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleepiness. Timepoint: Before intervention and 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Epworth sleepiness scale questionnaire.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZeinab Emami
Faculty of pharmacy, Shahid Beheshti University of Medical Sciencses
Outcome results
None listed