Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
Comparison of the Safety and Efficacy of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week, Randomized, Double-blind,Comparative, Parallel-group Study
The primary objective is to compare the potential for next-day residual effects of
eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning
using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic
primary insomnia and sleep maintenance difficulties.
The secondary objectives are to compare the clinical safety of both products, including the
potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to
compare the efficacy of both products on subjective sleep parameters and to compare the
effects of both products on patient's daytime functioning.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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