Dosage form, in particular
dietary supplement and / or pharmaceutical
dosage form, especially for
oral administration, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, sleep health and / or
sleep behavior, in particular
sleep onset and / or maintenance, and / or preferably for use in the prophylactic and / or therapeutic
medical treatment of sleep disorders, in particular
sleep onset and / or maintenance, and / or dysregulation of the natural day / night
rhythm and / or the
circadian rhythm, wherein the
dosage form is designed as a multiphase tablet, preferably a
multilayer tablet, in particular a two-layer tablet, preferably a three-layer tablet, wherein the
dosage form and / or the multiphase tablet has or consists of several, in particular at least two, preferably three, different phases, in particular
layers, wherein the different phases, in particular
layers, have different disintegration times and / or
drug release rates in the
gastrointestinal tract, in particular the
stomach and / or intestine, after
oral administration; where the dosage form and / or the multiphasic tablet is: a) a first phase (“immediate phase”), in particular a first layer (“immediate layer”), with rapid and / or immediate (immediate) disintegration and / or release of the
active ingredient in the
gastrointestinal tract, in particular the
stomach and / or intestine, following
oral administration, wherein the first phase, in particular the first layer, (i a )
Melatonin and (ii a ) contains an extract of Ashwagandha (
Withania somnifera) (“Ashwagandha extract”), b) a second phase (“depot phase”), in particular a second layer (“depot layer”), with controlled and / or delayed (retarded) disintegration and / or
drug release in the
gastrointestinal tract, in particular the
stomach and / or intestine, following oral administration, wherein the second phase, in particular the second layer, (i b )
Melatonin and (ii b) contains at least one extract of at least one sleep-promoting and / or sedating
drug (
plant or
herb), preferably an extract of valerian (
Valeriana officinalis) (“
valerian extract”), c) optionally a
third phase (“chronophase”), in particular a third layer (“chronolayer”), with continuous disintegration and / or release of the active substance in the gastrointestinal tract, in particular the stomach and / or intestine, following oral administration, wherein the
third phase, in particular the third layer, (i c) contains at least one (further) extract of at least one sleep-promoting and / or sedating drug (
plant or
herb), preferably at least two (further) extracts of different sleep-promoting and / or sedating drugs (plants or herbs), preferably an extract of valerian (
Valeriana officinalis) (“
valerian extract”) and / or an extract of
lavender (
Lavandula angustifolia) (“
lavender extract”), particularly preferably an extract of valerian (
Valeriana officinalis”) (“
valerian extract”) and an extract of
lavender (
Lavandula angustifolia) (“
lavender extract”); in particular wherein the dosage form contains
melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains
withanolide glycosides, in particular
withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.