Combination product to aid relaxation and sleep

Abstract

The present invention relates to a combination product comprising, as active substances, at least vitamin B6, melatonin, passionflower, chamomile and lemon balm to aid relaxation and / or falling asleep. The invention finally relates to the use of a combination product as previously defined for the treatment of somnipathies.

Description

Title of the invention: Combination product to aid relaxation and sleep

[0001] The present invention relates to a combination product comprising, as active substances, at least vitamin B6, melatonin, passionflower, chamomile and lemon balm to aid relaxation and / or falling asleep. The invention finally relates to the use of a combination product as previously defined for the treatment of somnipathies. Technical field

[0002] A sleep disorder (somnipathy) is a disorder related to an individual's sleep habits. Some sleep disorders are serious enough to interfere with physical, mental, and emotional functioning. A commonly used test for sleep disorders is polysomnography.

[0003] Sleep disorders can be caused by a variety of problems, from teeth grinding (bruxism) to night terrors. When an individual has difficulty falling asleep for no apparent reason, this is called insomnia. In addition, sleep disturbances can cause the individual to sleep excessively, a condition known as hypersomnia. Other sleep disorder conditions may be linked to substantial abuse.

[0004] Sleep disorders include:

[0005] - primary insomnia - chronic difficulty falling asleep and / or maintaining sleep when no other symptomatic cause can be perceived;

[0006] -bruxism, involuntary grinding or clicking of teeth during sleep;

[0007] - delayed sleep phase syndrome, inability to fall asleep or wake up during socially acceptable hours but causing no problems in sleep maintenance, a circadian rhythm disorder (similar symptom - hypernycthemeral syndrome);

[0008] -hypopnea, respiratory or cardiac abnormality during sleep;

[0009] -narcolepsy, sudden sleep often spontaneous at any time of day;

[0010] -cataplexy, sudden weakness of the motor muscles which can result in a fall to the ground;

[0011] -night terror, pavor nocturnus, nocturnal disorder characterized by strong fear and anxiety;

[0012] -sleepwalking, an activity undertaken physically and unconsciously during sleep;

[0013] -somniphobia, fear of sleeping;

[0014] -sleep apnea.

[0015] Following the evolution of knowledge about sleep in the 20th century, including the discovery of hypnology and sleep apnea, the medical importance of sleep was recognized. The clinical community became more interested in sleep disorders, such as sleep apnea, and the role and quality of sleep in different conditions. During the 1970s in the United States, clinics and laboratories devoted themselves to the study of sleep and its disorders.

[0016] The impact of sleep disorders on individuals' lives can be very significant: a 2014 study established that sleep perceived as being of poor quality is associated with an increased risk of suicide in the elderly (average age in the study, 74.9 years plus or minus 5.6 years).

[0017] Sleep medicine is now adapted in internal medicine, family medicine, pediatrics, otolaryngology, psychiatry and neurology.

[0018] The present invention relates to a composition for aiding relaxation and falling asleep in adults and children.

[0019] Indeed, a study published in the journal Paediatrica (vol 14 n°3 2003) takes stock of sleep disorders in children. Up to 25% of young children and almost 50% of school-aged children have sleep disorders that have lasted for at least 6 months. The prevalence is 33% for adolescents. Hedger Archbold et al. have differentiated these disorders. Some sleep disorders are more frequent at a certain age and linked to specific situations, others can occur at any age (for example: sleep apnea syndrome, sleep-related epilepsy). A sleep disorder is not only a problem for parents. Disturbed sleep also involves risks for the child's cognitive development with the occurrence of behavioral disorders. As in adults, there seems to be an association between obstructive sleep apnea and a higher prevalence of metabolic syndrome in children and adolescents..

[0020] The duration and organization of sleep are subject to changes during development. Basic knowledge allows us to distinguish true sleep disorders from variations in the norm. As a guide, the approximate values ​​of sleep duration per 24 hours are: 16 hours for a full-term newborn, 13 hours for a 2-year-old child, 11 hours at 5 years, 10 hours at 9 years, and about 9 hours for a 14-year-old adolescent. Young adults still need about 8 hours, a fact that is often forgotten. The variability of these values ​​is quite significant and corresponds to the distribution of genetic traits in the population. Individual sleep needs are more easily established during weekends and holidays, when the body is allowed to sleep as long as necessary.

[0021] During the night we observe three states: wakefulness, paradoxical sleep (rapid eye movement sleep or REM sleep) and slow-wave sleep (non-REM sleep). A sleep cycle includes a passage through all three states. In deep sleep, different parasomnias (non-REM parasomnias) can originate: for example, night terrors in young children, which are replaced by sleepwalking in older children. Since sleep cycles with deep phases occur in the first half of the night, it is common to observe these parasomnias during the first hours after falling asleep.

[0022] There are a number of products on the market to alleviate problems with falling asleep or relaxing. Examples of these products include products marketed by Valdispert such as Nuit Paisible, which contains melatonin, magnesium, zinc and vitamin B6, or Bonne Nuit, which contains melatonin alone. SomniPhyt from Santé Verte contains melatonin combined with Griffonia Simplicifolia, Magnolia officinalis, Valeriana Officinalis, Eschscholzia calfornica, L-tryptophan, L-glutamine, Hypericum perforatum and vitamin B6. The Nova Nuit Sommeil product from Sanofi is based on passionflower, melatonin, California poppy, lemon balm and vitamin B6. The OptiNuit Flash product from Nutreov contains melatonin and vitamin B6. Granions' Somdor+ Melatonin product contains melatonin, an extract of lemon balm, hawthorn, passionflower, hops and valerian.

[0023] None of the proposed products contain the combination that is the subject of the present invention.

[0024] These products, although containing melatonin in combination with vitamin B6, passionflower, chamomile and lemon balm, do not provide complete satisfaction in terms of calming, relaxation and / or helping to fall asleep. The combination product of the present invention provides a calming effect to facilitate falling asleep, particularly for children, and help them naturally regain restful sleep, without waking up at night. The product according to the present invention has no side effects or habituation. The combination product according to the present invention helps to aid falling asleep, soothes, relaxes and helps to maintain healthy sleep. It also contributes to the proper functioning of the nervous system.

[0025] The product according to the present invention also has the advantage of preferably containing no artificial coloring, allergens and of being, preferably, lactose-free or gluten-free.

[0026] The product of the present invention has a galenic suitable for children and adults, preferably in the form of a capsule. Summary

[0027] The present invention relates to a combination product, comprising as active substances, at least:

[0028] (i) vitamin B6

[0029] (ii) melatonin,

[0030] (iii) passionflower,

[0031] (iv) chamomile, and

[0032] (v) lemon balm

[0033] to aid relaxation and / or falling asleep.

[0034] The present invention also relates to a combination product, comprising as active substances, at least:

[0035] (i) vitamin B 6

[0036] (ii) melatonin,

[0037] (iii) passionflower,

[0038] (iv) chamomile, and

[0039] (v) lemon balm

[0040] for its use in the treatment of somnipathies.

[0041] In certain embodiments, the combination product according to the invention comprises, in addition to vitamin B6, melatonin, passionflower, chamomile and lemon balm, as active substances:

[0042] -Plants or plant extracts, such as for example orange blossom, lavender, hawthorn, marjoram, hops, gentian, valerian and / or rhodiola,

[0043] -Vitamins and minerals, such as for example vitamin D, B group vitamins, magnesium and / or calcium

[0044] -Amino acids or amino acid derivatives, such as for example tryptophan

[0045] In certain embodiments of the invention, the combination product according to the invention may be in the form of a single composition containing at least as active substances:

[0046] (i) vitamin B6

[0047] (ii) melatonin,

[0048] (iii) passionflower,

[0049] (iv) chamomile, and

[0050] (v) lemon balm

[0051] in a physiologically acceptable medium.

[0052] In some embodiments, the combination product is in the form of a single composition comprising: - From 0.5 to 4 mg, preferably from 1 to 2 mg of vitamin B6 - 50 to 5000 mg, preferably 50 to 2000 mg of passionflower - 5 to 400 mg, preferably 10 to 320 mg of chamomile - 5 to 300 mg, preferably 10 to 180 mg of lemon balm - 0.5 to 3.0 mg, preferably 1.0 to 2.5 mg of melatonin in an acceptable physiological environment.

[0053] According to a particular embodiment of the invention, the combination product is characterized in that the active ingredients (i), (ii), (iii), (iv) and (v) are in a medium suitable for oral administration. Preferably, the combination product is in the form of powder or a capsule containing said powder.

[0054] When used for the therapeutic treatment of sleep disorders, the combination product according to the present invention is in particular intended for adults or children.

[0055] Passionflower, chamomile and lemon balm may be present as ingredients (iii), (vi) or (v) in a combination product of the invention in more or less purified form, in particular in the form of a plant extract.

[0056] The various embodiments of the invention are particularly described in the detailed description below. These embodiments can be taken separately or in combination with each other. Description of the embodiments

[0057] In the present invention, the applicant has demonstrated that the combination of at least (i) vitamin B6, (ii) melatonin, (iii) passionflower, (iv) chamomile and (v) lemon balm, exhibits a synergistic effect to aid relaxation and / or falling asleep.

[0058] By synergistic effect, it is understood according to the present invention that the combination of at least (i) vitamin B6, (ii) melatonin, (iii) passionflower, (iv) chamomile and (v) lemon balm has an effect on aiding relaxation and / or falling asleep, during the treatment which is greater than the cumulative effects of a treatment (a) comprising the administration of vitamin B6, not associated with melatonin, passionflower, chamomile and lemon balm, or a treatment (b) comprising the administration of melatonin, not associated with vitamin B6, passionflower, chamomile and lemon balm, and conversely of a treatment (c) comprising the administration of passionflower, not associated with vitamin B6, melatonin, lemon balm and chamomile or of a treatment (d) comprising the administration of chamomile, not combined with vitamin B6, melatonin, lemon balm and passionflower or treatment (e) including the administration of lemon balm,not associated with vitamin B6, melatonin, passionflower and chamomile.

[0059] Vitamin B6

[0060] Vitamin B6 is a water-soluble vitamin that exists in several forms, pyridoxal phosphate being its biologically active form, as a cofactor involved in several reactions of amino acid metabolism, including transaminations, deaminations and decarboxylations. Pyridoxal phosphate in- also intervenes in the hydrolysis reaction of glycogen into glucose.

[0061] Vitamin B6 is known in seven different forms, interconvertible with each other except for the last one:

[0062] 1. pyridoxine (PN), the form in which vitamin B6 is administered in food supplement,

[0063] 2. pyridoxine phosphate (PNP),

[0064] 3. pyridoxal (PL),

[0065] 4. pyridoxal phosphate (PLP), biologically active form (distributed as vitamin supplement “P-5-P”),

[0066] 5. pyridoxamine (PM),

[0067] 6. pyridoxamine phosphate (PMP),

[0068] 7. 4-pyridoxic acid (PA), catabolite excreted in the urine.

[0069] Vitamin B6 participates in the transformation of tryptophan into vitamin B3, and in the metabolism of lipids and amino acids (decarboxylation and transamination). Pyridoxal phosphate allows the conversion of glycogen into glucose (Glucose-1-Phospate) by Glycogen phosphorylase.

[0070] Vitamin B6 also participates in the biosynthesis of serotonin.

[0071] It is present in significant quantities in poultry, livers (beef, lamb, veal), bananas, different forms of cabbage, tomatoes, spinach, potatoes, etc.

[0072] Combined with cystine, it is administered to facilitate the development of appendages (hair, nails, etc.).

[0073] According to a preferred embodiment of the present invention, vitamin B6 is present in the composition according to the invention in a content of 0.5 to 4 mg, preferably 1 to 2 mg per single composition.

[0074] Melatonin

[0075] Melatonin (or N-acetyl-5-methoxytryptamine), often referred to as the sleep hormone, is best known as the central hormone regulating chronobiological rhythms, being synthesized mainly at night. It regulates numerous hormonal secretions in humans and all mammals. This neurohormone is synthesized from a neurotransmitter, serotonin, which itself derives from tryptophan. It is secreted by the pineal gland (in the brain) in response to the absence of light.

[0076] Melatonin is also synthesized by the retina but also by bone marrow cells, lymphocytes and epithelial cells. Normally, the concentration of melatonin in these cells is greater than that found in the blood, but it does not appear to be regulated by photoperiod.

[0077] Walnuts and hazelnuts are an important source of melatonin easily absorbed by the body. Melatonin is also found in corn, tomatoes, and potatoes, but in significantly lower quantities. The melatonin content of several foods is still poorly understood. The body can also extract it from plant sources (rice, bananas, pineapples, etc.).

[0078] Normally, melatonin is secreted only at night (peak secretion at 5 a.m. in humans, and on average, because its production is inhibited by light) and it manages (in part) circadian rhythms.

[0079] Taking melatonin makes it easier to fall asleep (falling asleep 8 minutes earlier on average) and lengthens sleep (by 27 minutes on average). The combination of light and melatonin also reduced aggressive behavior (-9%), phases of agitation and nighttime awakenings.

[0080] The administration of melatonin in rats would produce an effect as anxiolytic as a reference drug, diazepam (Valium), administered at the same dose (1 mg-kg-1).

[0081] According to a preferred embodiment of the present invention, melatonin is present in the composition according to the invention in a content of 0.5 to 3.0 mg, preferably 1.0 to 2.5 mg per single composition.

[0082] Passionflower

[0083] Passiflora is a genus of plants, the passion flowers, of more than 530 species in the Passifloraceae family. They are climbing plants with spectacular flowers, but their abundance is only guaranteed in regions with a mild climate.

[0084] The aerial parts of passionflower (Passiflora incarnata) are known in phytotherapy for their anxiolytic and sedative action.

[0085] Indeed, Passiflora incamata has several alkaloids including monoamine oxidase inhibitors (MAOIs) and mild sedatives.

[0086] According to a preferred embodiment of the present invention, passionflower is present in the composition according to the invention in a content of 50 to 5000 mg, preferably 50 to 2000 mg of passionflower per single composition.

[0087] Preferably, the passion flower is in the form of an aqueous dry extract of the flowering aerial part of the passion flower and present in a content of 500 to 5000 mg, preferably 500 to 2000 mg in plant equivalent.

[0088] Chamomile or Matricaria recutita

[0089] Wild Chamomile, Matricaria recutita, Lesser Chamomile, (Matricaria recutita) is an annual herbaceous plant of the Asteraceae family and the genus Matricaria. It is sometimes called German Chamomile or True Chamomile or Stubborn Chamomile.

[0090] It is a medicinal plant used since Greco-Latin antiquity, simply called "chamomile" in herbalism.

[0091] Matricaria recutita is distinguished from the other two medicinal camomiles by the fact that it is an annual plant, consisting of a single erect stem.

[0092] A number of activities of matricaria chamomile have been demonstrated by in vitro and in vivo studies:

[0093] -Anti-inflammatory: this property can be attributed to chamazulene, its precursor matricin, (-)-a-bisabolol and its oxide. Good anti-inflammatory activity has been clearly established on induced rat paw edema, induced arthritis and radio-induced erythema26. (-)-a-bisabolol opposes gastric ulceration induced by different agents (ethanol, stress, indomethacin, in rats, orally). A wound on the rat's tongue, treated with chamomile ointment, heals more quickly (because it promotes epithelialization with a better percentage of collagen fibers).

[0094] -Spasmolytic: the hydroalcoholic extract of the flowers is spasmolytic. This activity could be due to apigenol which is more active than papaverine on isolated guinea pig ileum

[0095] -Antibacterial, antifungal: The essential oil of matricaria chamomile is weakly antibacterial and antifungal. It stimulates bile secretion in cats and dogs.

[0096] -Sedative: observations in humans have reported a sedative action of matricaria chamomile.

[0097] Matricaria chamomile is used like Roman chamomile: it is known to be tonic, stomachic, antispasmodic and analgesic.

[0098] According to a preferred embodiment of the present invention, chamomile is present in the composition according to the invention in a content of 5 to 400 mg, preferably 10 to 320 mg of chamomile per single composition.

[0099] Preferably, the chamomile is in the form of an aqueous dry extract of the aerial part of the chamomile and present in a content of 20 to 400 mg, preferably 40 to 320 mg in plant equivalent.

[0100] Lemon balm

[0101] Lemon balm or lemon balm (Melissa officinalis) is a perennial herbaceous plant of the Lamiaceae family. Its name comes from the Greek melissophullon, which means "bee leaf." It is also called lemon balm or simply lemongrass, not to be confused with lemongrass (Cymbopogon citratus) used in Asian cuisine. It is a plant native to the eastern Mediterranean basin, which has spread throughout Europe since ancient times. Lemon balm, or lemon balm, has been cultivated in gardens since ancient times. Originally from Europe, it was introduced to North America. The stems and leaves are still used as a tonic and mild stimulant. The taste is astringent and the aroma Light. The alcohol is obtained by distilling its fresh leaves: lemon balm water has antispasmodic properties. Lemon balm can also be consumed in the form of herbal teas.

[0102] Lemon balm is most often used for its calming and relaxing properties. In fact, it regulates nerve impulses, which has a beneficial effect on tachycardia, but also reduces spasms of the stomach and colon (it also has antifungal properties). In infusion, lemon balm has a slightly sedative effect, and also promotes sweating, which is why it is recommended in cases of insomnia, or in cases of high heat in infants and the elderly.

[0103] According to a preferred embodiment of the present invention, lemon balm is present in the composition according to the invention in a content of 5 to 300 mg, preferably 10 to 180 mg of lemon balm per single composition.

[0104] Preferably, the lemon balm is in the form of a dry hydroalcoholic extract of lemon balm leaves and present in a content of 30 to 300 mg, preferably 60 to 180 mg in plant equivalent.

[0105] Physiologically acceptable medium

[0106] A physiologically acceptable medium is a medium having no toxic or detrimental effects under the conditions of use and inert with respect to the active ingredients of the combination product. Such a medium may, for example, comprise different adjuvants depending on its therapeutic or cosmetic purpose, such as, but not limited to, flavorings, colorants, fillers, preservatives, diluents, wetting or suspending agents, etc. Such media may also allow immediate, modified or delayed release of one or other of the active ingredients.

[0107] The physiologically acceptable medium may be composed of water, fruit puree and / or juice, texturizers, emulsifiers, colorants, preservatives, flavorings, sugar or sugars.

[0108] By "fruit puree and / or juice" is meant a more or less liquid preparation, in particular depending on the nature of the fruit and / or the fineness of the grinding, prepared by grinding, pressing or other extraction process of one or more fruits and possibly concentration of the ground material obtained and / or separation (in particular filtration) of the seeds, achenes and / or all or part of the pulp, and / or flash pasteurization.

[0109] The fruits can be chosen from: apple, banana, strawberry, peach, raspberry, blackberry, mango, kiwi, blueberry, blackcurrant, redcurrant, orange, cherry, fig, pear, apricot, coconut, passion fruit, guava, papaya, melon, lychee, pineapple, lemon, mandarin, mirabelle plum, grapefruit, grape, rhubarb and mixtures thereof, without this list being exhaustive.

[0110] By "texturants" we mean compounds that modify the texture of the products in which they are incorporated. Examples of texturants are: guar and carob; gums arabic, xanthan and gellan; carrageenans; starches (native or modified); microcrystalline cellulose; gelatin; pectin; alginates (E400 to E405); agar-agar; and mixtures thereof. By "emulsifiers" is meant amphiphilic compounds characterized by their HLB (Hydrophilic Lipophilic Balance) value, in particular capable of stabilizing oil-in-water emulsions (particularly interesting if one wishes to add, for example, fat-soluble active ingredients such as fat-soluble vitamins. Examples of food emulsifiers are lecithin and its derivatives present in particular in egg yolk; mono- and diglycerides of fatty acids; and polysorbate 80.

[0111] By "colorants" is meant compounds of natural or synthetic origin capable of conferring a coloring to the composition on their own. Examples of food colorings are known in Europe under the codes El00 to El80.

[0112] By "preservatives" is meant compounds inhibiting the proliferation of microorganisms, in particular yeasts and / or molds and / or bacteria, in particular Staphylococcus Aureus, in the composition. Examples of food preservatives are sorbic acid and its salts (E200 to E203); benzoic acid and its salts (E210 to E219); sulfites and derivatives (E220 to E228); natamycin; nisin; and mixtures thereof. Preferably, the composition according to the invention does not comprise any preservative.

[0113] By "flavors" is meant compounds of natural or synthetic origin capable of modifying the taste of the composition on their own. Examples of flavors are apricot, pineapple, banana, blackcurrant, cherry, lemon, lime, strawberry, raspberry, passion fruit, mandarin, mint, orange, pistachio, pear, licorice, rose, anise, blueberry, cinnamon, ginger, grapefruit, apple, kiwi, lychee, melon, coconut, peach, redcurrant, guava, grenadine, mango, blackberry, papaya, vanillin, natural vanilla extract, essential oils and mixtures thereof.

[0114] By sugar or sugars is meant, within the meaning of the present invention, any sweetening carbohydrate, preferably glucose syrup, sucrose, glucose, fructose, invert sugar, honey, maltose, polyol or mixtures thereof. In the context of the present invention, the sugar used is a polyol, preferably sorbitol.

[0115] Additional asset(s)

[0116] Any additional active ingredient of nutritional interest and / or aiding relaxation or falling asleep may also be added to the combination products of the invention in pharmaceutical or cosmetic form. The combination product may comprise, for example, vitamins, mineral salts, essential amino acids, essential fatty acids, trace elements, various plant extracts, fibers, antioxidants, flavonoids.

[0117] Advantageously, such an additional active ingredient may be intended to reinforce the desired effect as described above.

[0118] Of course, those skilled in the art will take care to choose the additional active ingredients and their quantity in such a way that the advantageous properties of the composition in accordance with the invention are not, or not substantially, altered by the envisaged addition.

[0119] As additional usable assets, we can cite:

[0120] - water-soluble vitamins and fat-soluble vitamins. Examples of Water-soluble vitamins present in the syrupy product prepared according to the invention include: vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (nicotinic acid) also called vitamin PP (Pellagra Preventive), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 or H (biotin), vitamin B9 (folic acid), vitamin B12 (cobalamin) and vitamin C (ascorbic acid). Examples of fat-soluble vitamins present in the syrupy product prepared according to the invention include: vitamin A (retinol), vitamin D3 (cholecalciferol), vitamin E (mixture of tocopherols and tocotrienols) and vitamin K (phylloquinone).

[0121] - antioxidants, such as curcuminoids; carotenoids, in particular chosen among beta-carotene, astaxanthin, zeaxanthin, lutein or compounds containing them such as goji berries; polyphenol compounds, flavonoids such as catechins; proanthocyanidins, anthocyanins, OPCs (procyanidolic oligomers); ubiquinones; coffee extracts containing polyphenols and / or diterpenes; chicory extracts; ginkgo biloba extracts; grape extracts rich in proanthocyanidins; chili pepper extracts; soybean extracts; cocoa; pomegranate; Emblica; Coenzyme Q10; selenium,

[0122] - minerals, such as zinc, calcium, copper, iron, iodine, manganese, selenium, chromium (III),

[0123] - amino acids, in particular sulfur-containing amino acids, such as precursors of glutathione, selenium amino acids, citrulline,

[0124] -phytosterols, resveratrol, hesperidin, neohesperidin, ortho-silicic acid, monomethylsilanetriol, and mixtures thereof.

[0125] In a particularly advantageous embodiment of the invention, the combination of active ingredients comprises, as additional active ingredient, a fat-soluble vitamin, in particular vitamin D3, minerals such as potassium or magnesium.

[0126] Preferably, a combination product according to the invention is administered orally. Suitable forms for oral administration are, for example, tablets, capsules, lozenges, powders, granules, lyophilisates, oral solutions and syrups. Tablets, powders, granules, lyophilisates, oral solutions oral and syrup forms are the currently preferred pharmaceutical or cosmetic form suitable for oral administration. In the case of the preparation of a solid composition in the form of tablets, the main active ingredients (i), (ii), (iii) or (iv) may, for example, be mixed with a physiologically acceptable vehicle such as gelatin, starch, magnesium stearate, talc, gum arabic or the like. The tablets may be of various types, with immediate, controlled or delayed release and possibly in effervescent or orodispersible form.

[0127] A capsule preparation is obtained by mixing the active ingredient (i), (ii), (iii) or (iv) in powder form and pouring the resulting mixture into soft or hard capsules.

[0128] Example of composition according to the invention (Table 1): Compounds Unit Quantity (in mg) Pyridoxine Hydrochloride (Vitamin B6) 1.870 Melatonin 1.850 Passionflower (flowering aerial parts extract) 150.000 Chamomile (flower dry extract) 20.000 Lemon Balm (leaf dry extract) 13.333 Sorbitol 147.900 Calcium Stearate 5.000 Hydroxypropyl Methylcellulose 76.000

[0129]

[0130] This composition is obtained by mixing the different compounds according to the methods conventionally used for this type of preparation. The composition is then preferably injected into capsules.

Claims

Claims

1. Combination product comprising as active substances, at least: (i) vitamin B 6 (ii) melatonin, (iii) passionflower, (iv) chamomile, and (v) lemon balm

2. Combination product according to claim 1, characterized in that it is in the form of a single composition comprising: - From 0.5 to 4 mg, preferably from 1 to 2 mg of vitamin B6 - from 50 to 5000 mg, preferably 50 to 2000 mg of passionflower - from 5 to 400 mg, preferably 10 to 320 mg of chamomile - from 5 to 300 mg, preferably 10 to 180 mg of lemon balm - from 0.5 to 3.0 mg, preferably 1.0 to 2.5 mg of melatonin in a physiologically acceptable medium.

3. Combination product according to one of the preceding claims, characterized in that the physiologically acceptable medium is suitable for oral administration.

4. Combination product according to one of the preceding claims, characterized in that it is in the form of a capsule comprising the active ingredients in powder form.

5. Combination product according to one of the preceding claims, characterized in that the passionflower, chamomile and lemon balm are in the form of plant extracts.

6. Combination product according to at least one of the preceding claims, for the treatment of subjects suffering from somnipathy.