Evaluating the effect of zolpidem and suvorexant on walking ability.
- Conditions
- walking (adapt)ability, risk of falling
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
1. Male and female subjects aged between 65 years and 80 years (inclusive) at screening.
2. Body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive) at screening.
3. Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-95 mmHg, and pulse rate 45-100 bpm(inclusive), measured on either arm, after 5 min in the supine position at screening.
4. Estimated creatinine clearance (using the Cockcroft &Gault formula) =60 mL/min to allow for some reduced renal function in the elderly.
5. Subject has a regular sleep pattern (bedtime between 22:00 and 00:30 and sleep for at least 6 h).
1. Hypersensitivity to benzodiazepines and/ or meeting contraindication criteria for zolpidem: myasthenia gravis, sleep apnea syndrome, liver failure, respiratory depression.
2. Hypersensitivity to orexin antagonist and/ or meeting contraindication criteria for suvorexant: narcolepsy.
3. Regular use of sedative/hypnotic drugs.
4. Regular use of walking aids.
5. Recurrent fallers defined as > 3 falls per year.
6. Neurological diseases and/or orthopedic problems interfering with gait function
7. Mini Mental State Examination score < 25 at Screening.
8. Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
9. Vaccination for SARS-CoV-2 within 4 days of screening and/or dosing with study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method