Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1    Pharmacodynamic properties
Pharmacotherapeutic group: Other hypnotics and sedatives.
ATC code: N05CM
No pharmacological studies were conducted with Nerven film coated tablets or the fixed combination of Hawthorn leaf and flower, Hawthorn berries, Passion flower, Valerian root and Hop strobile dry extract.
However, the sedative effects of preparations of Valerian root and Hop strobile have been long recognised empirically and have been confirmed for Valerian root preparations in preclinical tests and controlled clinical studies. So far no clinical studies have been conducted with hop extracts alone as active drug for insomnia, but at least four randomized, placebo- or reference-controlled prospective clinical studies have been carried out with fixed combinations of dry extracts prepared from valerian root and hop strobilies with methanol 45% (m/m).
Orally administrated fixed combinations of these extracts in the recommended dosage have been shown to improve sleep latency and sleep quality. These effects cannot be attributed with certainty to any known constituents. Several mechanisms of action possibly contributing to the clinical effect have been identified for diverse constituents of Valerian root (sesqulterpenols, lignans, flavonoids) and include interactions with the GABA-system, agonism at the A1 adenosine receptor and binding to the 5-HT1A receptor.
Also several mechanisms of action have been identified for diverse constituents of Hops with the GABA-system, agonism at the melatonin receptors (ML1 and ML2) and binding to serotonin receptor subtypes (5-HT4e , 5-HT6 and 5-HT7). Whether hop strobile extract acts either as a mild sedative independently or as a synergist for valerian root extract, is not yet known.
For Passionflower pharmacodynamic data implies that the anxiolytic effects may be mediated via modulation of the GABA system.
No conclusive data exists for Hawthorn preparations.
The active pharmaceutical ingredient is represented by the fixed extract combination as the clinical effect cannot be attributed to single constituents.

Pharmacokinetic Properties

5.2    Pharmacokinetic properties
No data are available.