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Ingredient Profiles*
FOR EDUCATIONAL USE ONLY - NOT FOR PROMOTIONAL USE
COMPONENT
EFFECT*
Suntheanine®
Suntheanine® is a patented form of an amino acid that helps regulate serotonin levels and produces a calming effect. L-Theanine reduces stress, resulting in less
time needed to fall asleep. Suntheanine helps the patient wake up alert yet has a relaxing and calming mode of action (GABA, serotonin); inhibition of cortical neuron
excitation and acts as a mild anxiolytic. Suntheanine® naturally helps reduce stress, promotes relaxation and may reduce the stimulant effects of caffeine.
Cyracos®
(Lemon Balm)
Lemon balm is a anxiety-modulating botanical, in vitro inhibitor and neuroendocrine transducer. It offers mild GI benefits and data suggesting worry/stress reduction.
Lemon balm is generally considered safe. It was reported as well-tolerated with no statistically significant differences in side effects between treatment and placebo
when 240 mg was given with valerian root.
Valerian Root
Valerian root supports endogenous melatonin secretion and encourages natural relaxation. It has long been used as a natural ingredient to treat insomnia without
significant negative effects. Valerian root has significant clinical data supporting overall reductions in anxiety and stress without causing drowsiness.
L-Glycine
L-Glycine is an inhibitory neurotransmitter shown to produce a generalized calming effect. L-glycine has also been linked to reducing stress and anxiety while
helping to restore circadian rhythm. Studies report 3g of L-glycine per day, given before bed is safe with no significant side effects. L- glycine has been clinically
documented to improve overall sleep quality in both adult and pediatric studies.
Bromelain
Bromelain exhibits anti-inflammatory effects helping to relieve minor aches and pain that can inhibit the sleep cycle. Bromelain also eases gastrointestinal
discomfort that may contribute to sleeplessness. Bromelain is considered to be safe and nontoxic and without significant side effects at doses from 200-2000 mg.
Bromelain has been shown in clinical studies to naturally reduce the symptoms associated with GERD and improve general gastrointestinal health.
(L-Theanine)
Pantothenic Acid
(B5)
All ingredients found in NoctoPlex are within recommended amounts for children and adolescents
Pantothenic acid helps correct sleep disturbances caused by minor body aches, while naturally lowering tension levels. This helps lessen the time it takes to fall
asleep and promotes sleep duration. It also helps correct sleep disturbances especially those related to stress; muscle cramping and adrenal function.
Recommended Daily Allowances for Vitamin B5 are 4 mg (age 9-13 years) and 5 mg (over 14 years old). There are no established upper intake limits for Vitamin B5
due its generally accepted safety.
Magnesium
Magnesium is a prerequisite for natural melatonin production. Magnesium has been shown to boost mood and can reduce muscle cramps and spasms.
Magnesium is an essential nutrient; the NIH has set tolerable upper intake limits for magnesium supplementation. For children and adolescents from age 9-18
years, this is set at an upper limit of 350 mg.
Melatonin
Melatonin is generally regarded as well-tolerated and considered efficacious in adult and pediatric populations for restoring circadian rhythms.
Zinc
Zinc, in combination with magnesium and melatonin has shown in studies to improve quality of sleep. Zinc helps the body produce adequate levels of natural
melatonin. The NIH recommends tolerable upper intake limits for children and adolescents of 23 mg (9-13 years) and 34 mg (14-18 years).
Vitamin B6
Adequate amounts of B-complex are essential to a healthy sleep cycle. The B vitamins are essential in the diet and are well tolerated. The NIH Recommended
Dietary Allowance for Vitamin B6 is 1.0 mg for age 9-13 years and 1.2 mg (female) or 1.3 mg (male) for age 14-18 years (24). Vitamin B6 has tolerable upper
intake limits of 60-80 mg per day for children and adolescents.
Vitamin B12
Vitamin B12 is a water-soluble vitamin that is readily removed from the body. Because of its accepted safety and low risk of toxicity, there are no recommended
upper intake limits. It’s recommended dietary allowances are 1.8 µg for ages 9-13 years and 2.4 µg for ages over 14 years.
Vitamin C
Vitamin C is necessary in the diet and is a catalyst in the absorption of nutrients in the body.
Clinical Support for Clinical Evaluation
of the Safety and Tolerability:
NoctoPlex for Kids was formulated by a board
certified pharmacologist and each of the 12
ingredients were critically assessed first for safety
and then for efficacy. Further, NoctoPlex for Kids
has been reviewed and vetted for pediatric clinical
trials by the prestigious New England Institutional
Review Board. There have been no reported
adverse events or side effects with the use of
NoctoPlex for Kids or adults.
Randomized, double-blinded, crossover study conducted
using NoctoPlex for Kids vs. placebo and baseline readings
Falling Asleep
Overall Asleep
Waking Up
After Waking Up
NoctoPlex for Kids
(14.8% improvement)
NoctoPlex for Kids
(9.5% improvement)
NoctoPlex for Kids
(17.7% improvement)
NoctoPlex for Kids
(10.2% improvement)
Placebo
(1.6% improvement)
Placebo
(4.9% improvement)
Placebo
(3.57% improvement)
Placebo
(2.2% improvement)
Efficacy:
The New England Independent Review Board
(NEIRB) reviewed and approved the protocol for
a placebo controlled, double blind, pediatric
clinical trial to evaluate the safety and tolerability
of NoctoPlex for Kids. The study formally
approved a study entitled, “A Double Blind,
Cross Over, Efficacy Study of NoctoPlex for Kids
for Improvement of Sleep Quality in Children” in
May of 2015.
The objective of the study was to assess the
effect of NoctoPlex for Kids on pediatric sleep
quality as compared to a placebo in 120
subjects. The study participants received blinded
bottles, took NoctoPlex for Kids and the placebo
units, separated by a two day washout period.
The subject’s caregiver assessed the child’s
change in sleep quality, sleep duration and
mental equity after awaking. The study results
illustrated significant improvements over the
placebo in helping the participants fall asleep,
stay asleep and awaken easier. Significant
improvements in alertness were also reported as
outlined in the chart below.
9x
2x
5x
5x
“NoctoPlex for Kids
shorten the time it took
to get to sleep.”
“NoctoPlex for Kids
significantly increased
overall quality of sleep.”
“NoctoPlex for Kids
lessened the time it
took to wake up.”
“Children experienced
an increase in alertness
upon awakening.”
* FOR HEALTHCARE PROFESSIONAL EDUCATION ONLY: The makers of NoctoPlex for Kids® make no therapeutic claims. NoctoPlex for
Kids® is available through healthcare professional recommendation only. NoctoPlex for Kids® is a dietary supplement. Statements made
about NoctoPlex for Kids® have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any
disease. Effects of each ingredient listed is the interpretation by Union Springs Healthcare of third party clinical information.
Suntheanine® is a registered trademark of Taiyo International. Cyracos® is a registered trademark of Naturex.
© Union Springs Healthcare 2016