The primary objective is to compare the potential for next-day residual effects of volinanserin 2 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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
2 mg tablets QD
1 mg tablets (overencapsulated) QD
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sleepiness in the morning measured on a visual analog scale of the patient's sleep questionnaire
Time frame: 4 weeks
Other measure of next-day residual effects (ability to concentrate of the patient's sleep questionnaire)
Time frame: 4 weeks
Rebound effect measured by pr-WASO and pr-SOL on patient's sleep questionnaire during the run-out period
Time frame: 4 weeks
Subjective sleep parameters
Time frame: 4 weeks
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