KARLSRUHE, Germany, 30 June 2006.

A recently published study shows that Euvegal® (Schwabe's proprietary Valerian/Melissa combination product) clearly improves pathological restlessness and insomnia in children under the age of 12. Therapeutic efficacy and tolerability were evaluated in a total of 918 children in this open, multicenter study [1].

Children suffering from general motor restlessness are unable to sit still and their hands are always ‘‘on the move’’. Particularly in situations which demand discipline and attention (e.g. during school), many children show a continuous motor restlessness. If no other symptoms of an endogenous or psychotic disease are present and no neurological deficits can be found, such behavior is called hyperkinetic syndrome [2]. Dyssomnia in children is expressed as difficulty in falling asleep or in sleeping through the night. The incidence of such disturbances in children is about 30%.

After an average treatment period of four weeks, more than 80% of the insomnia patients and more than 70% of the patients with restlessness improved clearly in this study. The improvement for other investigated symptoms such as hyperactivity, lack of concentration, or listlessness was 37.8% on average.

The tolerability of Euvegal® was excellent with no study medication-related adverse events noted in the course of the study. These results are in line with the findings of previous clinical studies of Euvegal® in adults [3, 4].

“This study shows that the herbal combination product Euvegal® provides a fast and significant improvement of restlessness and insomnia in children” says study author Dr. Stephan Klement. “More than two out of three patients clearly improved during treatment. With no study medication-related adverse events noted, Euvegal® may represent an efficacious and very safe natural alternative to synthetic psychotropic drugs. “

The unique herbal preparation combines well-balanced amounts of the proprietary extracts WS® 1014 from Valerian root and WS® 1303 from Melissa leaves, two medicinal herbs that complement each other regarding their therapeutic effects. The drug was developed and is produced by Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany, the leading research-based phytomedicines company worldwide.

Contact:
Dr. Willmar Schwabe Pharmaceuticals
Willmar-Schwabe-Str. 4
76227 Karlsruhe

Dr. Jochen Muehlhoff
Phone: +49 721 4005 216
Email: jochen.muehlhoff@schwabe.de

[1] Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children. Phytomedicine 2006, 13: 383–387.
Link to the Pubmed abstract of above publication.
[2] Psychosocial Paediatrics Committee (Canadian Paediatric Society CPS), 2002. The use of alternative therapies in treating children with attention deficit hyperactivity disorder.
Paediatr. Child Health 7(10), 710–718.
[3] Dreßing H, Köhler S, Müller WE. Improvement of sleep quality with a highly dosed valerian/balm preparation. A placebo-controlled double-blind study.
Psychopharmakotherapie, 1996, 3: 123-130.
[4] Schmidt U, Krieger W, Frerick H, Schenk N. Psychosomatic and mental disorders: Valerian and Balm instead of synthetic psychopharmaceuticals. Der Allgemeinarzt 1992 (14): 15-19.