FIELD

The present disclosure relates to sleep inducing compositions. DEFINITIONS As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicates otherwise.

Anxiolytic: The term "anxiolytic", also known as anti-panic, and anti-anxiety agent, refers to medication or other intervention that inhibits anxiety. Serotonin booster: Serotonin is a monoamine neurotransmitter, biochemically derived from tryptophan, and is primarily found in the gastrointestinal tract (GI tract), blood platelets, and the central nervous system (CNS) of animals, including humans. Serotonin is suggested to be a contributor to feelings of well-being and happiness. Substances that contribute to this feeling of well-being and happiness are referred to as "serotonin boosters". BACKGROUND

The background information herein below relates to the present disclosure but is not necessarily prior art.

Sleep disorders are a group of conditions that affect the ability of a human to sleep well on a regular basis. Sleep disorders can be caused by health problems or by too much stress, and are becoming increasingly common all over the world. Stress, hectic schedules, and other outside influences may result in occasional sleep problems. However, when these issues begin to occur on a regular basis and interfere with daily life, it may indicate a sleeping disorder. People experiencing sleep disorders may have a difficult time falling asleep and may feel extremely tired throughout the day. The lack of sleep can have a negative impact on energy, mood, concentration, and overall health.

There are different types of sleep disorders; some may be caused due to underlying health conditions. Insomnia refers to the inability to fall asleep or to remain asleep. It can be caused by jet lag, stress and anxiety, hormones, or digestive problems. It may also be a symptom of another underlying condition. Sleep apnea is characterized by pauses in breathing during sleep. Parasomnias are a class of sleep disorders that cause abnormal movements and behavior during sleep, such as sleepwalking, sleep talking, groaning, nightmares, bed wetting, teeth grinding, and jaw clenching.

Known treatments for sleep disturbances include the use of sleeping pills, melatonin supplements, breathing device or surgery (usually for sleep apnea), medications for any underlying health issues, a dental guard (usually for teeth grinding). Further, lifestyle adjustments can improve the quality of sleep. However, use of these medications have undesirable side effects, such as burning or tingling in the hands, arms, feet, or legs, changes in appetite, constipation, diarrhea, difficulty keeping balance, dizziness, daytime drowsiness, dry mouth or throat, and depressed breathing while sleeping.

Therefore, there is felt a need to provide a composition that overcomes the drawbacks mentioned herein above.

OBJECTS

Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.

It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.

Another object of the present disclosure is to provide a sleep inducing composition.

Still another object of the present disclosure is to provide a safe sleep inducing composition that does not have any adverse side effects.

Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY

The present disclosure provides a sleep inducing composition. The composition comprises an anxiolytic in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition, a sedative in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition, a serotonin booster in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition, and a coolant in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition. The anxiolytic is an extract of Withania somnifera, the sedative is an extract of Nardostachys jatamansi, the serotonin booster is at least one selected from the group consisting of extract of Bacopa monnieri, extract of Convolvulus pluricaulis, extract of Celastrus paniculatus, and extract of Centella asiatica, and the coolant is selected from extract of Mentha spicata, and Camphor. The extract used in the sleep inducing composition can be at least one of aqueous extract, and alcoholic extract in an oil base.

DETAILED DESCRIPTION

Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details, are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail. The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a," "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," "including," and "having," are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.

Sleep disorders, such as insomnia are a subjective complaint of sleep described as delayed, insufficient in duration and/or poor quality of sleep. Insomnia is a disorder, wherein individuals find it difficult to fail asleep, stay asleep, or both. They don't feel refreshed when they wake up from their sleep. Lack of sleep leads to fatigue and other symptoms. Sometimes, insomnia could be due to some other underlying disorders/ diseases. The short- term insomnia is known as acute insomnia which could last days to weeks and is typically caused by stress or an upsetting event. The long-term or chronic insomnia is usually bad sleep or no sleep at least thrice a week or more, over at least 3 months period. It is often secondary to another problem of combination of problems such as medical conditions, psychological issues, substance abuse, and the like. One of the triggers for primary insomnia is an ever evolving work schedule.

People with insomnia usually report at least one of the symptoms such as waking too early in the morning, refreshing sleep, and trouble falling to sleep. It is seen that lack of sleep affects women more than men and can affect almost ail age-groups. Lack of sleep leads to several medical conditions and is known to be one of the important factors for chronic diseases.

Restoration of the sleep is an important parameter for good Quality of Life (QoL) for all individuals. Poor quality of sleep (non-restorative sleep) and the sleep disturbance is associated with daytime fatigue. This causes clinically significant distress and impairment in social, occupational, or other important areas of functioning and feeling of well-being.

There are several different interventional and non-interventional methods, such as to provide conducive environment and comfortable mattress, room temperature for inducing and sustaining good quality sleep. Medications such as sleeping pills, melatonin supplements, mild tranquilizers, anxiolytic agents, and medications for any underlying health issues are given to reduce anxiety, and stress in the patients with insomnia. However, use of these medications have undesirable side effects, such as burning or tingling in the hands, arms, feet, or legs, changes in appetite, constipation, diarrhea, difficulty keeping balance, dizziness, daytime drowsiness, dry mouth or throat, and depressed breathing while sleeping.

The present disclosure envisages a sleep inducing composition, that mitigates the drawbacks mentioned hereinabove.

The sleep inducing composition of the present disclosure comprises an anxiolytic, a sedative, at least one serotonin booster, and a coolant. In one embodiment, the anxiolytic is an extract of Withania somnifera in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition. The sedative is an extract of Nardostachys jatamansi in an amount in the range of 1 wt% to 99 wt% of the total amount of the composition. Typically, the serotonin booster is at least one selected from the group consisting of extract of Bacopa monnieri, extract of Convolvulus pluricaulis, extract of Celastrus paniculatus, and extract of Centella asiatica. The amount of the serotonin booster is in the range of 1 wt% to 99 wt% of the total amount of the composition. The coolant can be selected from extract of Mentha spicata, and Camphor. The amount of the coolant is in the range of 1 wt% to 99 wt% of the total amount of the composition.

Withania somnifera (Solanaceae) is found in Nepal, China, and Ye man.

Nardostachys jatamansi (Caprifoliaceae) is endemic to the eastern Himalayas, primarily in a belt through Kumaon, Nepal, and Bhutan.

Bacopa monnieri (Plantaginaceae) also known as waterhyssop, thyme-leafed gratiola, water hyssop, herb of grace, is a perennial, creeping herb native to the Australia, Europe, Africa, Asia, and North and South America.

Mentha spicata (Lamiaceae), has a subcosmopolitan distribution across Europe, Africa, Asia, Australia, and North America.

Convolvulus Pluricaulis (Convolvulaceae) is endemic to Burma.

Celastrus paniculatus (Celastraceae) is a climbing shrub found in Asia.

Centella asiatica (Apiaceae) also known as centella, and Asiatic pennywort is native to wetlands in Asia. The plant parts used in the sleep inducing composition of the present disclosure can be derived from the barks, roots, tubers, stigma, kernels, exudates, stolons, rhizome, leaves, seeds, nuts, berries, fruits, stems and flowers of the plants are commercially purchased from the market as value added products and therefore, the specific source of the product is unknown. In an embodiment of the present disclosure, the sleep inducing composition comprises extracts of Withania somnifera, Nardostachys jatamansi, Bacopa monnieri. Convolvulus pluricaulis, Celastrus paniculatus, Centella asiatica, and Mentha spicata. Typically, the extracts used in the sleep inducing composition of the present disclosure can be aqueous extract or alcoholic extract. In one embodiment, the extracts are in an oil base. In an embodiment, the individual components of the sleep inducing composition of the present disclosure are present in equal quantities with respect to each other.

In an embodiment of the present disclosure, the sleep inducing composition comprises the anxiolytic in an amount in the range of 10 wt% to 80 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 80 wt% of the total amount of the composition, the sedative in an amount in the range of 10 wt% to 80 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 80 wt% of the total amount of the composition, the serotonin booster in an amount in the range of 10 wt% to 80 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 80 wt% of the total amount of the composition, and the coolant in an amount in the range of 10 wt% to 80 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 80 wt% of the total amount of the composition.

In another embodiment of the present disclosure, the sleep inducing composition comprises the anxiolytic in an amount in the range of 20 wt% to 60 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 40 wt% of the total amount of the composition, the sedative in an amount in the range of 20 wt% to 60 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 40 wt% of the total amount of the composition, serotonin booster in an amount in the range of 20 wt% to 60 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 40 wt% of the total amount of the composition, and the coolant in an amount in the range of 20 wt% to 60 wt% of the total amount of the composition, preferably in an amount in the range of 20 wt% to 40 wt% of the total amount of the composition.

In an exemplary embodiment of the present disclosure, the sleep inducing composition comprises 25 wt% of Withania somnifera oil, 25 wt% of Nardostachys jatamansi oil, 25 wt% of at least one selected from the group consisting of Bacopa monnieri oil, Convolvulus pluricaulis oil, Celastrus paniculatus oil, and Centella asiatica oil, and 25 wt% of at least one of Mentha spicata oil and Camphor.

In accordance with the embodiments of the present disclosure, the sleep inducing composition can be in a dosage form selected from the group consisting of liquid, gel, oil, and cream. In one embodiment of the present disclosures, the sleep inducing composition is in the form of oil.

The sleep inducing composition of the present disclosure can be applied topically to any portion of the human body. In one embodiment, the sleep inducing composition is topically applied to the umbilical region of a subject. The superficial epigastric artery runs in the superficial fascia of the umbilicus and supply blood to the skin below the umbilical region. This results in the absorption of the ingredients present in the sleep inducing composition directly in the circulatory system of the subject. Another method of application, which is independent and adjuvant to the method mentioned above includes applying the sleep inducing composition to the forehead of the subject, until the ingredients are absorbed into the systemic system.

The sleep inducing composition of the present disclosure can be used for inducing sleep in individuals who experience sleep disorders. The topical formulation provides a soothing and calm effect, and induces drowsiness to the individual. Further, the sleep inducing composition does not have any side effects and can be easily applied. The sleep inducing composition exerts its action by a combination of mechanisms, such as the anxiolytic effect of Withania somnifera, the sedative effect of Nardostachys jatamansi, the feeling of well- being and happiness due to the use of Bacopa monnieri. Convolvulus pluricaulis, Celastrus paniculatus, and Centella asiatica, and the cooling effect of Mentha spicata, and Camphor.

The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

The present disclosure is further described in light of the following laboratory scale experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following laboratory experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial/commercial scale. Experimental Details

Experiment- 1: Sleep inducing composition in accordance with the present disclosure

Sleep inducing composition of the present disclsoure in the form of oil was prepared by using the ingredients as summarized in Table- 1. Oil of Withania somnifera, Nardostachys jatamansi, Bacopa monnieri. Convolvulus pluricaulis, Celastrus paniculatus, Centella asiatica, and Mentha spicata along with Camphor, were commercially purchased from the local market. The amount of each ingredient is given in grams (g).

Table- 1

Coolant

Mentha 25 — 25 25 —

spicata

Camphor — 25 — — 25

The effectiveness of the sleep inducing composition of the present disclosure in inducing sleep was demonstrated by the following anecdotal study.

Healthy individuals between the ages of 40 to 65 years of both genders were included in the study. In order to assess the effectiveness of the sleep inducing composition of the present disclsoure, a specific sleep assessment questionnaire was developed to collect information from the participants on a. Sleep and health history

b. Life balance

c. Sleep hygiene

d. Insomnia severity

e. Epworth Sleepiness Scale to assess Sleep.

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire, which is helpful in diagnosing sleep disorders.

The baseline data was collected from 30 participants having chronic insomnia over months to years. All the participants were given a uniform self-assessment questionnaire to rate their sleep after using the oil on the daily basis, and the following information was collected from each participant: a. Time at which the oil was applied

b. Time taken to fall asleep

c. Number of awakenings during the night

d. Wake up time next morning

e. Signs and symptoms experienced in the morning (e.g. heavy head, sleep feeling, feeling fresh, ability to do daily routine etc.)

f. Data on smoking, alcohol consumption, tea-coffee consumption was also collected.

30 participants were selected for the study and were randomly divided into 2 groups (Group-I and Group-II) containing 15 individuals each. Group-II was the control group and was divided into 5 sub-groups of 3 participants each. All the participants were instructed to apply the oil given to them every day prior to sleep and keep a record of the same. The oil given to Group-I participants contained the sleep inducing composition of the present disclosure. The detail of the composition given to Group-II participants is summarized in Table-2.

Table-2

The participants were all adults above 40 years of age. Some of the individuals also had some underlying chronic disorder such as diabetes, hypertension, Chronic obstructive pulmonary disease (COPD), while the rest of the participants were primary insomnia patients with no co- morbid conditions.

The study was carried out for 15 days and the participants were prohibited from using any other sleep medication/ supplements during the study period.

The sleep inducing composition was able to induce sleep through percutaneous/ transdermal absorption (naval route); the onset of action was variable and so also the duration of sleep. All the participants from Group-I recorded improvement in their sleep duration as well as quality over the period of use. They were able to manage their daily routine the next day and felt more fresh and energetic due to improved sleep. None of the participants reported any negative side effects. Though, some of the participants from Group-II record some level of sedation and lessening in the anxiety level, none of the participants from Group-II record any improvement in the sleep duration or quality. Therefore, it is evident from the above study that the sleep inducing composition of the present disclosure comprising an anxiolytic (Withania somnifera), a sedative {Nardostachys jatamansi), a serotonin booster (selected from Bacopa monnieri, Convolvulus pluricaulis, Celastrus paniculatus, and Centella asiatica), and a coolant (selected from Mentha spicata, and Camphor), in the specific quantity is effective in improving the sleep duration and quality in an individual suffering from insomnia, without any negative side effects. The ingredients of the composition of the present disclosure act synergistically to induce sleep. The sleep inducing composition of the present disclosure is able to pass through the skin as an external/topical application and is able to induce and sustain sleep due to its action on the sleep centres in the Central Nervous System. Improvement in quality of sleep, leads to improvement in quality of life and helps to restore the disturbed physiological processes to normalcy and this in long turn can help for better health and clinical outcomes in individuals with insomnia and other co-morbid conditions.

TECHNICAL ADVANCES

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a sleep inducing composition that is capable of regulating sleep, and does not have any undesirable side effects.

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

The foregoing description of the specific embodiments so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

The use of the expression "at least" or "at least one" suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results. Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.