Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

Launched by NEURIM PHARMACEUTICALS LTD. · Jan 2, 2009

Keywords

ClinConnect Summary

Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs w...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)
• Exclusion Criteria:
• • According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
• • Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
• • Severe neurological, psychiatric or sleep disorders;
• • Other serious diseases;
• • Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
• • Subjects who need beta blockers as a treatment.