Composition, dosage form and associated dietary supplement for reducing the sleep onset phase and improving the sleep-wake rhythm

Abstract

Composition including: a) Melatonin up to 5 mg; b) Magnesium up to 500 mg c) Withania somnifera up to 2 g; d) Gamma-aminobutyric acid up to 500 mg; e) L-tryptophan up to 1 g; f) L-Theanine up to 50 mg; g) 5-Hydroxytryptophan up to 100 mg; h) Matricaria chamomilla extract up to 500 mg; i) Valeriana officinalis extract up to 800 mg; and j) Vitamin B6 up to 5 mg.

Description

Brief description of the invention

[0001] The present invention relates to a composition, dosage form and associated dietary supplement for improving the sleep-wake rhythm.

[0002] Sleep is essential for human life, with humans spending approximately one-third of their lives asleep. Numerous studies show that sleep is a crucial factor for health and performance. Many key processes within the human body occur exclusively during sleep, such as certain regeneration processes, memory consolidation, and other physiological functions. The recommended number of hours of sleep for adults is between seven and nine. Even with generous estimates, nearly half of all Germans suffer from chronic sleep deprivation. Worldwide, the number of people suffering from sleep problems and / or sleep deprivation is around 30 percent in industrialized countries. In modern society, a lack of sleep, due to lifestyle and technology, for example, is having increasingly negative effects on health.Long working hours, increased stress, constant connectivity, and the presence of screens, as well as stress, depression, anxiety, acute stress reactions, lack of exercise, dissatisfaction, poor eating habits, and imbalance, disrupt the natural circadian rhythm that governs the sleep-wake cycle. Exposure to blue light from devices in the evening can inhibit melatonin production, making it difficult to fall asleep. These changes lead to many people regularly getting less sleep than recommended, which in the short term impairs energy and quality of life and in the long term increases the risk of various health problems, such as obesity, diabetes, and cardiovascular disease. Consequently, health and longevity are negatively impacted by sleep deprivation.

[0003] Supporting the onset of sleep and the sleep phase itself, as well as reducing potential deficiencies, can improve sleep quality, leading to a more restorative sleep experience. Furthermore, it is essential to restore the natural circadian rhythm. The circadian rhythm is the organism's ability to synchronize physiological processes to a period of approximately 24 hours. This internal clock controls many biological processes in the body, including the sleep-wake cycle. Light is the most important external factor influencing this rhythm. Special photoreceptors in the eye act as a central switch for the circadian clock. Light signals to the body when it is time to be awake and when it is time to sleep. Modern lifestyles with artificial light and screen time in the evening can disrupt this natural rhythm, leading to sleep problems.

[0004] Numerous compositions and dietary supplements intended to improve sleep or aid in falling asleep are known from the prior art. Primarily pharmacological sleep aids, which promote relaxation or artificially induce sleep, affect sleep in an unnatural way and are usually associated with strong side effects and the risk of addiction. Another method for influencing sleep is described, for example, in WO 2007 / 095605 A1. This method for accelerating the restoration of a circadian rhythm uses a pheromone or a pheromone analogue. Furthermore, creatine is also used in the prior art to positively influence sleep quality, as can be seen, for example, in DE 19537494 A1.Natural compositions in the form of dietary supplements hardly exist, or only a) with individual active ingredients; b) active ingredients that are provided in an ineffective combination; c) an overdosed or underdosed dosage of the contained active ingredients; d) untested ingredients, such as "Novel Foods".

[0005] The object of the present invention is therefore to provide an improved composition comprising carefully selected active ingredients that contribute to the regulation of the sleep-wake rhythm and are intended to shorten the time it takes to fall asleep.

[0006] The present invention therefore relates to a composition comprising: a) Melatonin; b) Magnesium; c) Withania somnifera; d) Gamma-aminobutyric acid; e) L-Tryptophan; f) L-Theanine; g) 5-Hydroxytryptophan; h) extract of Matricaria chamomilla; i) Extract of Valeriana officinalis; and j) Vitamin B6.

[0007] The maximum content of the components is: a) Melatonin up to 5 mg; b) Magnesium up to 500 mg c) Withania somnifera up to 2 g; d) Gamma-aminobutyric acid up to 500 mg; e) L-tryptophan up to 1 g; f) L-Theanine up to 50 mg; g) 5-Hydroxytryptophan up to 100 mg; h) Matricaria chamomilla extract up to 500 mg; i) Valeriana officinalis extract up to 800 mg; and j) Vitamin B6 up to 5 mg.

[0008] In a preferred embodiment, the composition comprises the following components: a) 1 mg melatonin; b) 500 mg magnesium bisglycinate, preferably comprising 100 mg magnesium and 400 mg glycine; c) 200 mg Withania somnifera, preferably comprising 5 mg withanolides; d) 50 mg gamma-aminobutyric acid; e) 190 mg L-tryptophan; f) 100 mg L-Theanine; g) 15 mg 5-Hydroxytryptophan; h) 100 mg extract of Matricaria chamomilla, preferably comprising 2 mg apigenin; i) 200 mg extract of Valeriana officinalis, preferably comprising 0.84 mg valerenic acid; and j) 1.4 mg Vitamin B6.

[0009] The present invention also relates to a dosage form containing the above composition, or comprising the following composition: a) 0.5 mg melatonin; b) 250 mg magnesium bisglycinate, preferably comprising 50 mg magnesium and 200 mg glycine; c) 100 mg Withania somnifera, preferably comprising 2.5 mg withanolides; d) 25 mg gamma-aminobutyric acid; e) 95 mg L-tryptophan; f) 50 mg L-Theanine; g) 7.5 mg 5-Hydroxytryptophan, preferably from 30 mg standardized Griffonia simplicifolia seed extract; h) 50 mg extract of Matricaria chamomilla, preferably comprising 1 mg apigenin; i) 100 mg extract of Valeriana officinalis, preferably comprising 0.42 mg valerenic acid; and j) 0.7 mg Vitamin B6.

[0010] The dosage form is preferably a capsule or tablet. The dosage form must include at least one additive in one aspect. This additive may be, for example, a filler, a disintegration accelerator, a colorant, a film former, and / or a thickening agent.

[0011] Furthermore, in one embodiment, the dosage form may also include at least one excipient. The excipient is preferably sugar, binder, lubricant, oil, wax, gelatin, magnesium stearate, talc, carboxylpolymethylene, carboxylmethylcellulose, cellulose acetate phthalate, and / or polyvinyl acetate.

[0012] In a particularly preferred aspect of the invention, the dosage form is a hard gelatin capsule, a soft gelatin capsule, an enteric-coated capsule, a hydroxypropylmethylcellulose (HPMC) capsule, a modified-release capsule and / or a film-coated capsule.

[0013] Furthermore, the invention also relates to one of the above compositions or a previously described dosage form as a dietary supplement for reducing the sleep onset phase and / or improving the sleep-wake rhythm.

[0014] The object of the invention is described in particular by a composition according to claim 1, the dosage form according to claim 3, and the dietary supplement according to claim 10. Advantageous embodiments with expedient further developments of the invention are specified in the remaining claims. Detailed description of the invention

[0015] The present invention relates to a composition, dosage form and associated dietary supplement for improving the sleep-wake rhythm and / or for shortening the sleep onset phase.

[0016] In today's world, characterized by daily stress and constant accessibility via mobile devices such as smartphones and tablets, restful sleep is a rare commodity. However, sleep is an essential aspect of human health. Without a regulated sleep-wake cycle and adequate sleep duration, life expectancy decreases and certain diseases become more prevalent. This invention aims to promote better sleep by using selected components to contribute to a shorter sleep onset time and a regulated sleep-wake cycle.

[0017] In the following, the articles “ein” and all derivatives thereof, as used here, should generally be understood as “one / an / an or several”, unless otherwise specified or the singular form is evident from the context.

[0018] Where the terms “contains”, “has”, “possesses” and the like are used in the description or claims, these terms shall be understood in the same way as the terms “possessing” or “comprising”, i.e., not exhaustively, unless explicitly stated otherwise.

[0019] Nutrients within the meaning of the present invention include vitamins, minerals, trace elements, secondary plant compounds, amino acids, amino acid derivatives, components of amino acids, intermediates and / or glycosaminoglycans.

[0020] In the present invention, the term "substance" shall be understood to mean a plant-based active ingredient that can be used for dietary supplement purposes. The use of the substance, an extract thereof, or a preparation made from the substance shall be generally considered the active ingredient in the following, regardless of whether the efficacy-determining, i.e., therapeutically active, constituents are known. The term "extract" here includes not only dry extracts but also oils or thick extracts, which can be obtained from natural starting materials such as plant parts and may consist of a mixture of different components.

[0021] Surprisingly, it was found that a combination of selected ingredients, as included in the composition according to the invention, leads to a reduction in the time it takes to fall asleep and has a positive influence on the circadian rhythm, thereby increasing the quality of life.

[0022] The invention therefore relates to a composition comprising: k) Melatonin; l) Magnesium; m) Withania somnifera; n) Gamma-Aminobutyric Acid; o) L-Tryptophan; p) L-Theanine; q) 5-Hydroxytryptophan; r) Matricaria chamomilla extract; s) Extract of Valeriana officinalis; and t) Vitamin B6.

[0023] The maximum content of the components is: k) Melatonin up to 5 mg; l) Magnesium up to 500 mg m) Withania somnifera up to 2 g; n) Gamma-aminobutyric acid up to 500 mg; o) L-tryptophan up to 1 g; p) L-Theanine up to 50 mg; q) 5-Hydroxytryptophan up to 100 mg; r) Matricaria chamomilla extract up to 500 mg; s) Valeriana officinalis extract up to 800 mg; and t) Vitamin B6 up to 5 mg.

[0024] Melatonin is a naturally occurring hormone that plays a key role in regulating the body's sleep-wake cycle. Its production is stimulated by darkness and inhibited by light, helping the body recognize the day-night cycle and regulate sleep phases accordingly. Numerous studies have shown that melatonin supplementation can shorten the time it takes to fall asleep, promote uninterrupted sleep, and optimize sleep phases. Since the body's own melatonin production begins to decline as early as the beginning of one's twenties, supplementation can be beneficial for improved sleep. The decline in melatonin production becomes more pronounced with age and is particularly noticeable in postmenopausal women.

[0025] Magnesium is a vital mineral found in every organ of the human body and involved in over 300 enzymatic reactions. For example, magnesium is also involved in regulating neurotransmitters and controlling the sleep-wake cycle. It interacts with the neurotransmitter GABA (gamma-aminobutyric acid), which plays a crucial role in promoting relaxation and sleep. Studies have shown that the interaction of magnesium with GABA can have a calming effect and facilitate the transition to sleep. Furthermore, magnesium supports the production and release of melatonin. Magnesium also has anti-inflammatory properties, which can reduce inflammation associated with sleep problems.Despite its essential importance, studies have shown that many people do not reach the recommended daily intake of magnesium, which can lead to a magnesium deficiency that affects sleep.

[0026] In a preferred embodiment of the present invention, magnesium bisglycinate is used. Glycine is an amino acid that promotes healthy sleep by lowering body temperature, which signals the body to prepare for sleep. Studies have shown that glycine supplementation can improve sleep quality, for example, by positively influencing REM sleep, which is important for brain recovery.

[0027] Withania somnifera (Ashwagandha, Winterberry) is a plant that plays a central role in traditional Indian Ayurvedic medicine. It has been used for millennia to treat a variety of ailments and is considered an adaptogen, meaning it can help the body adapt to anxiety and stress, which are common causes of sleep problems. Studies have shown that Withania somnifera promotes healthy sleep by, for example, reducing the production and secretion of stress hormones such as cortisol, which has a calming effect on the nervous system and makes it easier to fall asleep and stay asleep.

[0028] Gamma-aminobutyric acid (GABA) is an important inhibitory neurotransmitter in our central nervous system. GABA plays a crucial role in promoting relaxation, reducing stress and anxiety, and supporting sleep through its calming and inhibitory effects. By binding to GABA receptors in the brain, GABA lowers the excitability of nerve cells, which helps reduce levels of anxiety and stress—both factors that can negatively impact sleep. Furthermore, GABA contributes to stabilizing the sleep cycle by positively influencing deep sleep phases. As a result of more restful sleep, GABA improves overall sleep quality. L-tryptophan is an essential amino acid that the body cannot produce itself and therefore must be obtained through diet. Studies have shown that L-tryptophan plays a vital role in sleep, as it serves as a precursor in the body for the synthesis of serotonin, a neurotransmitter that helps regulate mood and sleep. Serotonin, in turn, is a precursor for the production of melatonin, the hormone that controls the sleep-wake cycle. L-theanine is an amino acid that promotes relaxation. Studies have shown that L-theanine increases the production of gamma-aminobutyric acid (GABA) and other neurotransmitters, such as serotonin, which play a central role in regulating relaxation and well-being. This, in turn, puts the body in a calmer state and makes it easier to fall asleep. Furthermore, L-theanine can reduce levels of stress hormones, such as cortisol. 5-Hydroxytryptophan (5-HTP) is a naturally occurring amino acid and a direct precursor to our body's own neurotransmitter serotonin, which, as previously described, contributes to the regulation of mood and sleep. Studies have shown that subjects who regularly took 5-HTP experienced a longer deep sleep phase and optimized sleep architecture. The 5-HTP in this formulation is preferably derived from a standardized extract of the African plant Griffonia simplicifolia, which is naturally rich in this compound.

[0029] Chamomile flower extract is obtained from the flowers of the chamomile plant (Matricaria chamomilla). Chamomile is known for its calming and anti-inflammatory properties. The extract contains several active ingredients, including bisabolol, flavonoids, and apigenin, which contribute to relaxation and have a calming effect on humans. Studies have shown that apigenin, similar to GABA, binds to specific receptors in the brain, producing calming effects. Chamomile's anti-inflammatory properties can also help alleviate ailments such as pain or digestive problems that disrupt sleep.

[0030] Valerian root extract is obtained from the roots of the Valeriana officinalis plant, which has been used for centuries in traditional medicine to promote sleep and reduce anxiety. The calming properties of valerian root extract are often used to facilitate falling asleep and improve sleep quality. Research further indicates that valerian root extract can be effective, particularly for individuals with mild to moderate sleep disturbances, by helping to increase total sleep time and reduce nighttime awakenings.

[0031] Vitamin B6 (pyridoxine) plays an important role in metabolism, particularly in the processing of amino acids, the synthesis of neurotransmitters such as serotonin and dopamine, and the formation of red blood cells. Due to its crucial role in the synthesis of important neurotransmitters, vitamin B6 can influence the sleep-wake cycle. Studies have shown that a vitamin B6 deficiency is associated with poorer sleep quality, shorter sleep duration, and difficulty falling asleep.

[0032] The composition according to the invention therefore combines the latest findings from neuroscience and combines evidence-based ingredients into a unique formulation to reduce the sleep onset phase, improve the sleep-wake rhythm and thus create a better quality of life through optimized sleep.

[0033] Preliminary results showed a reduced sleep onset time and an optimized sleep-wake rhythm when the composition was taken regularly and contained the following amounts: a) 1 mg melatonin b) 500 mg magnesium bisglycinate, preferably comprising 100 mg magnesium and 400 mg glycine; c) 200 mg Withania somnifera (Ashwagandha), comprising preferably 5 mg withanolides; d) 50 mg gamma-aminobutyric acid; e) 190 mg L-tryptophan; f) 100 mg L-Theanine; g) 15 mg 5-Hydroxytryptophan, preferably from 60 mg standardized Griffonia simplicifolia seed extract; h) 100 mg extract of Matricaria chamomilla, comprising preferably 2 mg apigenin, which corresponds to 2%; i) 200 mg extract of Valeriana officinalis (valerian root extract), comprising preferably 0.84 mg valerenic acid (0.42%); and j) 1.4 mg Vitamin B6.

[0034] In a particularly preferred embodiment, the composition, which is intended to lead in particular to a reduced sleep onset phase and / or an optimized sleep-wake rhythm, has no further components.

[0035] The composition described above represents the daily dose of nutrients, substances, and / or components. A daily dose is understood to be the amount of nutrients, substances, and / or components of the composition that is ingested or should be ingested per day. Consequently, the amount of nutrients, substances, and / or components of the composition may be reduced in a dosage form such as a capsule, requiring the composition to be ingested more than once daily. In a preferred embodiment, the daily dose is achieved through repeated ingestion. Therefore, the composition may also contain smaller amounts of the ingredients, while maintaining their relative proportions. An example of a composition that should preferably be taken twice daily is as follows: a) 0.5 mg melatonin b) 250 mg magnesium bisglycinate, preferably comprising 50 mg magnesium and 200 mg glycine; c) 100 mg Withania somnifera (Ashwagandha), comprising preferably 2.5 mg withanolides; d) 25 mg gamma-aminobutyric acid; e) 95 mg L-tryptophan; f) 50 mg L-Theanine; g) 7.5 mg 5-Hydroxytryptophan, preferably from 30 mg standardized Griffonia simplicifolia seed extract; h) 50 mg extract of Matricaria chamomilla, comprising preferably 1 mg apigenin, which corresponds to 2%; i) 100 mg extract of Valeriana officinalis (valerian root extract), comprising preferably 0.42 mg valerenic acid (0.42%); and j) 0.7 mg Vitamin B6.

[0036] The present invention also relates to a dosage form for a previously described composition. The dosage form of the present invention may, for example, but not limited to, the following dosage forms: solution, syrup, juice, oil, medicinal water, tincture, tea, solution for injection and infusion, percolate, spray, powder, granules, tablet, film-coated tablet, coated tablet, soft capsule, hard capsule, effervescent tablet, pill, stick, stick, caplet, suspension, emulsion, paste, cream, ointment, gel, suppository, liniment, electuary, buccal tablet, nanosuspension, plaster, transdermal patch, melt film and / or implant.

[0037] The dosage form, which can be used as a dietary supplement, comprises, as mentioned above, one of the compositions according to the invention. The term "dietary supplement" is used in particular for a foodstuff intended to supplement the normal diet. The dietary supplement comprises at least one nutrient or other substance that has a potential nutritional and / or physiological effect. The at least one ingredient, for example in the form of a nutrient, is present in a defined, measured amount. The dietary supplement is preferably designed as a dosage form such that defined amounts of the contained nutrient or corresponding composition are included in the dietary supplement. In a particularly preferred embodiment, the composition is used as a dosage form in the form of a capsule or a tablet.The term "capsule" as used in the present invention refers to a solid composition enclosed in a hard or soft shell of varying shape or size, for oral administration. Examples of capsules according to the invention include, but are not limited to, the following: hard gelatin capsules, starch capsules, soft gelatin capsules, microcapsules, gastro-resistant capsules, hydroxypropyl methylcellulose (HPMC) capsules, modified-release capsules, or film-coated capsules. In one embodiment, however, it may also be provided that the nutrient, substance, composition, and / or components are mixed with an inert carrier and then encapsulated. Inert carriers include, but are not limited to, cellulose, microcrystalline cellulose, hydroxypropyl methylcellulose, lactose, and / or sorbitol.Dosage forms with a composition according to the invention may, in one aspect, further comprise additives. The at least one additive includes, for example, but is not limited to, the following: fillers, disintegration accelerators, colorants, thickeners, film formers, oils, waxes, and others. In contrast to a capsule, the term "tablet" describes a solid body comprising the composition according to the invention and at least one excipient. The excipient may, for example, but is not limited to, the following: sugars, binders, lubricants, and the like. The at least one excipient includes, but is not limited to, dextrose, oil, wax, sorbitol, mannitol, polyvinylpyrrolidone, corn starch, alginic acid, starch or gelatin, magnesium stearate, talc, carboxylpolymethylene, carboxylmethylcellulose, cellulose acetate phthalate, and / or polyvinyl acetate.However, at least one excipient can also be used in other dosage forms.

[0038] In one aspect of the invention, the dosage form as a dietary supplement comprises at least one composition comprising: a) Melatonin up to 5 mg; b) Magnesium up to 500 mg c) Withania somnifera up to 2 g; d) Gamma-aminobutyric acid up to 500 mg; e) L-tryptophan up to 1 g; f) L-Theanine up to 50 mg; g) 5-Hydroxytryptophan up to 100 mg; h) Matricaria chamomilla extract up to 500 mg; i) Valeriana officinalis extract up to 800 mg; and j) Vitamin B6 up to 5 mg.

[0039] In a preferred embodiment, the dosage form as a dietary supplement comprises a composition including the following substances and components: a) 1 mg melatonin b) 500 mg magnesium bisglycinate, preferably comprising 100 mg magnesium and 400 mg glycine; c) 200 mg Withania somnifera (Ashwagandha), comprising preferably 5 mg withanolides; d) 50 mg gamma-aminobutyric acid; e) 190 mg L-tryptophan; f) 100 mg L-Theanine; g) 15 mg 5-Hydroxytryptophan, preferably from 60 mg standardized Griffonia simplicifolia seed extract; h) 100 mg extract of Matricaria chamomilla, comprising preferably 2 mg apigenin, which corresponds to 2%; i) 200 mg extract of Valeriana officinalis (valerian root extract), comprising preferably 0.84 mg valerenic acid (0.42%); and j) 1.4 mg Vitamin B6.

[0040] The dosage forms described above contain the daily dose of the composition with the nutrients, substances, and / or components that contribute to improved sleep. However, the amount of nutrients, substances, and / or components in a dosage form, such as a capsule, may be reduced, requiring the composition to be administered more than once daily to achieve the daily dose. In a preferred embodiment, the daily dose is achieved through repeated administration. Consequently, the dosage form can contain smaller amounts of the composition, while the ratios of the composition's ingredients remain unchanged.

[0041] In a preferred embodiment, two dosage forms are taken one hour before bedtime to achieve a positive effect on sleep. Each of these dosage forms comprises the following ingredients: a) 0.5 mg melatonin b) 250 mg magnesium bisglycinate, preferably comprising 50 mg magnesium and 200 mg glycine; c) 100 mg Withania somnifera (Ashwagandha), comprising preferably 2.5 mg withanolides; d) 25 mg gamma-aminobutyric acid; e) 95 mg L-tryptophan; f) 50 mg L-Theanine; g) 7.5 mg 5-Hydroxytryptophan, preferably from 30 mg standardized Griffonia simplicifolia seed extract; h) 50 mg extract of Matricaria chamomilla, comprising preferably 1 mg apigenin, which corresponds to 2%; i) 100 mg extract of Valeriana officinalis (valerian root extract), comprising preferably 0.42 mg valerenic acid (0.42%); and j) 0.7 mg Vitamin B6.

[0042] However, the daily dose of the composition can also be divided into any number of dosage forms, so that a higher number of capsules, lozenges, tablets, pills, dragees or other dosage forms can be used per day.

[0043] Further literature concerning known materials, processes and applications that can be used in accordance with the present invention is known to the person skilled in the art. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2007 / 095605 A1

[0004] DE 19537494 A1

[0004]

Claims

[1] Composition comprising: a) Melatonin up to 5 mg; b) Magnesium up to 500 mg c) Withania somnifera up to 2 g; d) Gamma-aminobutyric acid up to 500 mg; e) L-tryptophan up to 1 g; f) L-Theanine up to 50 mg; g) 5-Hydroxytryptophan up to 100 mg; h) Matricaria chamomilla extract up to 500 mg; i) Valeriana officinalis extract up to 800 mg; and j) Vitamin B6 up to 5 mg. [2] Composition according to claim 1 comprising: a) 1 mg melatonin; b) 500 mg magnesium bisglycinate, preferably comprising 100 mg magnesium and 400 mg glycine; c) 200 mg Withania somnifera, preferably comprising 5 mg withanolides; d) 50 mg gamma-aminobutyric acid; e) 190 mg L-tryptophan; f) 100 mg L-Theanine; g) 15 mg 5-Hydroxytryptophan; h) 100 mg extract of Matricaria chamomilla, preferably comprising 2 mg apigenin; i) 200 mg extract of Valeriana officinalis, preferably comprising 0.84 mg valerenic acid; and j) 1.4 mg Vitamin B6. [3] Dosage form comprising a composition according to claim 1 or 2, or comprising the following composition: k) 0.5 mg melatonin; l) 250 mg magnesium bisglycinate, preferably comprising 50 mg magnesium and 200 mg glycine; m) 100 mg Withania somnifera, preferably comprising 2.5 mg withanolides; n) 25 mg gamma-aminobutyric acid; o) 95 mg L-tryptophan; p) 50 mg L-Theanine; q) 7.5 mg 5-Hydroxytryptophan, preferably from 30 mg standardized Griffonia simplicifolia seed extract; r) 50 mg extract of Matricaria chamomilla, preferably comprising 1 mg apigenin; s) 100 mg extract of Valeriana officinalis, preferably comprising 0.42 mg valerenic acid; and t) 0.7 mg Vitamin B6. [4] Dosage form according to claim 3, wherein the dosage form is a capsule or tablet. [5] Dosage form according to claim 4, wherein the capsule is a hard gelatin capsule, a soft gelatin capsule, an enteric-coated capsule, a hydroxypropylmethylcellulose (HPMC) capsule, a modified-release capsule and / or a film-coated capsule. [6] Dosage form according to claims 3 to 5, wherein the dosage form comprises at least one additive. [7] Dosage form according to claim 6, wherein the at least one additive comprises a filler, a disintegration accelerator, a colouring agent, a film former and / or a thickening agent. [8] Dosage form according to any one of claims 3 to 7, wherein the dosage form comprises at least one excipient, wherein the excipient is preferably sugar, binder, lubricant, oil, wax, gelatin, magnesium stearate, talc, carboxylpolymethylene, carboxylmethylcellulose, cellulose acetate phthalate and / or polyvinyl acetate. [9] Dosage form comprising a composition according to claim 1 or 2, wherein the dosage form contains a smaller amount of the daily dose of the composition, preferably wherein the daily dose is distributed among one or more dosage forms. [10] A composition according to claim 1 or 2, or a dosage form according to any one of claims 3 to 9 as a dietary supplement for reducing the time it takes to fall asleep and / or improving the sleep-wake rhythm.