Composition for the Modulation of Circadian Rhythmicity and Sleep Quality

20210093687 ยท 2021-04-01

    Inventors

    Cpc classification

    International classification

    Abstract

    A composition of matter in the form of a base formula that is specifically formulated to be effective to overcome sleep issues. Optional additions to the base formula are disclosed to be effective in the improvement of specific sleep issues.

    Claims

    1. A circadian rhythm sleep aid effective to overcome sleep issues consisting essentially of: enzyme treated asparagus extract; curry tree leaf extract; citrus polymethoxylated flavones; sceletium tortuosm extract; ashwagandha extract; and black turmeric extract.

    2. The circadian rhythm sleep aid of claim 1, adding Melissa officinalis (L) from lemon balm extract, L-Theanine, and Gamma-aminobutyric acid (GABA).

    3. The circadian rhythm sleep aid of claim 1, adding Magnolia officinalis bark extract, Phellodendron amurense bark, Holy Basil extract, 5-hydroxytryptophan (5-HTP) from Griffonia simplicifolia seed extract, and Cucumis melo (L).

    4. The circadian rhythm sleep aid of claim 1, adding Vitamin B6, Magnesium, Melatonin, GABA, Apocynum venetum leaf extract, and White Peony Extract (Paeonia lactiflora).

    5. The circadian rhythm sleep aid of claim 1, adding Melissa officinalis (L) leaves, 6% rosmarinic acid, Salvia lavandulifolia and Salvia officinalis, L-Theanine, L-ergothioniene.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0025] In the accompanying figures, like reference numerals refer to identical or functionally similar elements throughout the separate views. The accompanying figures, together with the detailed description below are incorporated in and form part of the specification and serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the present invention, in which:

    [0026] FIG. 1 is a simplified block diagram representing the various blends that are based upon the base formula composition;

    [0027] FIG. 2 is a table of Circadian Timing Blend ingredients and their dosage ranges, according to an embodiment; and

    [0028] FIG. 3 shows an exemplary product label listing the ingredients in the fall asleep blend, according to an embodiment.

    [0029] While the invention as claimed can be modified into alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the scope of the present invention.

    DETAILED DESCRIPTION

    [0030] We discuss a composition of matter in the form of a circadian rhythm sleep aid specifically formulated to be effective to overcome sleep issues. Additional embodiments of the composition introduce the addition of optional ingredients chosen to target specific sleep dysfunctions to allow the body to get restorative sleep.

    [0031] The Applicant has conducted a sleep study to determine the efficacy of the invention. The study measured sleep quality and circadian rhythmicity and sleep quality by completing clinically validated and recognized standard questionnaires for evaluating circadian variables. In the study, half of the study's subjects described their sleep problem as lack of feeling rested upon waking. Furthermore, 25% of subjects reported that they had problems falling asleep. 25% of subjects reported their primary sleep concern was repeated nighttime waking. This study showed unexpected results in improving slow wave sleep, not as a function of merely increasing sleep time (which we know is flawed from non-benzodiazepine sleep aids) or stealing it from REM sleep as is commonly seen when making up a sleep deficit, but from managing it via mediating multiple circadian rhythm attributes through the use of the disclosed composition.

    [0032] The disclosed composition supports the circadian timing system in human beings as measured by sleep parameters, including sleep duration, sleep efficiency, sleep waking and sleep latency.

    Base Formula

    [0033] Referring now to FIG. 1, we disclose an embodiment of the invention, a base formula, Circadian Timing Blend 120. The Circadian Timing Blend 120 consists essentially of the following main ingredients preferably contained in one serving (two capsules): Enzyme treated asparagus extract, curry tree leaf extract (Murray Koenigii extract), Citrus polymethoxylated flavones, including nobiletin and tangeretin (from Citrus bioflavonoid extract), Sceletium tortuosum extract, Ashwagandha extract (Withania somnifera root and leaf (standardized to 10% withanolide), black turmeric extract (Kaempferia parviflora). The suggested dosage amounts for each ingredient of the Circadian Timing Blend 120 are provided in Table 1 200 of FIG. 2.

    Targeted Formulas

    [0034] Depending on the targeted sleep issue, other embodiments combine additional ingredients to the Circadian Timing Blend 120 to formulate other compositions effective to address specific sleep concerns. These additional ingredients can account for 50%-70% of the total composition ingredients.

    [0035] For example, a FALL ASLEEP blend 122 adds Melissa officinalis (L) from lemon balm extract, L-Theanine, and Gamma-aminobutyric acid (GABA). Someone who finds it difficult to fall asleep will benefit from taking two capsules 30 to 45 minutes before bedtime.

    [0036] A STAY ASLEEP blend 124 adds Magnolia officinalis bark extract and Phellodendron amurense bark, Holy Basil extract, 5-hydroxytryptophan (5-HTP) from Griffonia simplicifolia seed extract, and Cucumis melo (L). FIG. 3 shows an example of the product label listing the ingredients and amounts per serving. This blend 124 provides the nutrients you need to help you stay asleep by supporting the transition from slow-wave (light) sleep to REM sleep.

    [0037] A DEEP ASLEEP blend 126 adds Vitamin B6, Magnesium, Melatonin, GABA, Apocynum venetum leaf extract, and White Peony Extract (Paeonia lactiflora). Deep sleep is vital to recover from daily wear and tear on the brain and body. This formulation allows you to successfully enter the deep sleep cycle.

    [0038] A POWER NAP blend 128 adds Melissa officinalis (L) leaves, 6% rosmarinic acid, Salvia lavandulifolia and Salvia officinalis, L-Theanine, L-ergothioniene. Power naps as short as 20 minutes have been shown to improve energy, increase mental focus and creativity, improve memory, and enhance physical performance. The POWER NAP blend 128 is a non-drowsy formula that is most effective when taken in conjunction with a 20-minute nap.

    [0039] Although the present invention may be utilized in many different treatment modalities, it is discussed herein as an over-the-counter (OTC) sleep aid medication for compactness of disclosure. Without limiting the invention, a preferred embodiment of the invention is a medicine to be taken orally, such as a tablet, capsule, chewable tablet, or lozenge. Other forms of ingestion are contemplated within the spirit and scope of the disclosure. One with knowledge in the art will appreciate that the above-described formulas can be combined with inactive ingredients as required for chemical stability and to enhance flavor, appearance, and digestibility. It should be understood that one formula, or embodiment, can be combined with another embodiment.