Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

Exclusion Criteria

• •Females who are lactating or who are pregnant
• •Night shift workers, and individuals who nap 3 or more times per week over the preceding month
• •Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
• •Participation in another trial having received study medication within 1 month before the screening visit
• •Body Mass Index ≥ 33
• •Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
• •Use of any substance with psychotropic effects or properties know to affect sleep/wake
• •History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
• •Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
• •Positive qualitative urine drug screen (opiates, cocaine, amphetamine…)
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.