Insomnia caused by steroidal drugs
Conditions
Interventions
The group of Suvorexant: 65 years old and over is 15mg under 65years old is 20mg Drug administration for 28 days from baseline. Evaluation on baseline, and day7, 28 from baseline.
The grou
Sponsors
Gifu Prefectural General Medical Center
Gifu University Graduate School of Medicine, Department of General Internal Medicine Gifu Municipal Hospital, Department of General Internal Medicine Japanise Red Cross Gifu Hospital, Department of General Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients suffered from insomnia caused by steroidal drugs with agree with the purpose of this study. They should apply to diagnosis criteria of DSM-5 insomnia A(as follow)... A The patients remarkably has sleep disturbance about quantity and quality of sleep, and have one of these following symptoms... (1)Difficulty falling asleep (2)Difficulty maintaining sleep characterizes by frequent awakening, or difficulty falling asleep again after awkening (3)Early morning awakening, and unable to fall asleep again
Exclusion criteria
Exclusion criteria: Exclude patients who fall under... (1)Pregnant patient (2)Patients who originally had insomnia (3)Patients who are originally administered Suvolexant and the other sleep inducing agents (4)Patients who have been administered Suvorexant and the other sleep inducing agents (5)Patients who are administered anxiolytic (6)Patients who have depression (7)Patients who have sleep apnea syndrome (8)Patients who have liver or kidney disorder (9)Patients who have administered following drug that inhibits CYP3A4 strongly (itraconazole, clarithromycin, ritonavir, saquinavir, nelfinavir, indinavir, telaprevir, voriconazole)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep maintenance effect and fall asleep effect in 1 week and 1 month from baseline. Sleep maintenance effect sTST subjective total sleep time sWASO subjective wake after sleep onset sNAW subjective number of asakening Fall asleep effect sTSO subjective time to sleep onset Overall evaluation ISI Insomnia Severity Index PGI patient global impression of change Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects on vital signs, glucose tolerance, serum lipid levels, blood pressure by improving insomnia. vital sign height body weight blood pressure heart rate Glucose tolerance HbA1c GA glycoalbumin 1.5-AG Fasting blood glucose level Fasting blood insulin level Fasting blood C peptide Accumulation of urine C peptide Daily blood glucose fluctuation Lipid Total cholesterol HDL cholesterol LDL cholesterol Triglyceride Other eGFR | — |
Countries
Japan
Contacts
Public ContactHideyuki Okada
Gifu Prefectural General Medical Center General Internal Medicine
Outcome results
None listed