Duo Calm

Technical Information

SCHEDULING STATUS:
S0

PROPRIETARY NAME (AND DOSAGE FORM):
Duo Calm: Sleep Formula Capsules

COMPOSITION:
Each capsule provides:

%NRV

Valerian                              300mg                 *

Chamomile                          50mg                  *

Magnesium glycinate       125mg                 6%

Vitamin B6                          1.7mg                  100%

% Nutrient Reference Values (NRVs) for individuals 4 years and older

*NRV not established

PHARMACOLOGICAL CLASSIFICATION:
Category D Medicine. Combination Western Herbal.

PHARMACOLOGICAL ACTION:
Valerian is a natural sedative. Research shows that Valerian reduces sleep latency (the time taken to fall asleep), and also improves the quality of sleep. Chamomile has anti-spasmodic and sedative properties. The mineral Magnesium is responsible for muscle relaxation. Vitamin B6 works with Magnesium to promote muscle relaxation.

INDICATION:
This product is indicated when a deficiency of the active ingredients exists.

CONTRA-INDICATIONS:
If you suffer from a chronic medical condition use this product under the supervision of your healthcare practitioner.

INTERACTION:
If you are taking chronic prescription medication for any anxiety or depression, consult your healthcare practitioner before using this product. Discontinue use of this product 2 weeks prior to any planned surgical procedure.

PREGNANCY AND LACTATION:
Pregnant and breastfeeding women should avoid using this product.

DOSAGE AND DIRECTIONS FOR USE:
Take 1 capsule daily 30 minutes before bedtime.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Discontinue the use of this product where there is sensitivity towards any of the ingredients. Avoid using this product if you operate heavy machinery or drive long distances. Do not consume together with alcohol.

KNOWN SYMPTOMS OF OVERDOSE AND TREATMENT:
Use only as directed.

IDENTIFICATION:
Size 0 capsule with light brown powder in pearl-blue capsule.

PRESENTATION:
Glass bottle with 30 capsules.

STORAGE INSTRUCTIONS:
Store at or below 25º C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER/APPLICATION NUMBER:
This medicine has not been evaluated by the Medicines Control Council, nor is it intended to diagnose, treat, cure or prevent any disease.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Fusion Laboratories
www.fusionlabsonline.com
info@fusionlabsonline.com

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 2017

DISCIPLINE OF THE MEDICINE
Combination Western Herbal

REFERENCES

Valerian

1. Bent S, Padula A, Moore D, Patterson M, Mehling W. “Valerian for Sleep: A Systematic Review and Meta-Analysis.” American Journal of Medicine. 2006; 119(12):1005-1012.
2. Andreatini R, Leite JR. “Effect of Valepotriates (Valerian Extracts) in Generalized Anxiety Disorder: A Randomized Placebo-Controlled Study.” Phytotherapy Research. 1994; 8(7):467-470.
3. Fernandez-San-Martin MI, Masa-Font R, Palacios-Soler L, et al. “Effectiveness of Valerian on Insomnia: A Meta-Analysis of Randomized Placebo-Controlled Trials.” Sleep Medicine. 2010; 11(6):505-511.

Chamomile

1. Srivastava JK, Shankar E, Gupta S. “Chamomile: A Herbal Medicine of the Past with Bright Future.” Molecular Medicine Reports. 2010; 3(6):895-901.
2. Amsterdam JD, Li Y, Soeller I, Rockwell K, Mao JJ, Shults J. “A Randomized, Double-Blind, Placebo-Controlled Trial of Oral Matricaria Recutita (Chamomile) Extract Therapy for Generalized Anxiety Disorder.” Journal of Clinical Psychopharmacology. 2009; 29(4):378-382.
3. McKay DL, Blumberg JB. “A Review of the Bioactivity and Potential Health Benefits of Chamomile Tea (Matricaria Recutita L.).” Phytotherapy Research. 2006; 20(7):519-530.

Magnesium Glycinate

1. Barbagallo M, Dominguez LJ. “Magnesium and Aging.” Current Pharmaceutical Design. 2010; 16(7):832-839.
2. Abbasi B, Kimiagar M, Sadeghniiat K, Shirazi MM, Hedayati M, Rashidkhani B. “The Effect of Magnesium Supplementation on Primary Insomnia in Elderly: A Double-Blind Placebo-Controlled Clinical Trial.” Journal of Research in Medical Sciences. 2012; 17(12):1161-1169.
3. de Baaij JH, Hoenderop JG, Bindels RJ. “Magnesium in Man: Implications for Health and Disease.” Physiological Reviews. 2015; 95(1):1-46.

Vitamin B6

1. Dakshinamurti K, Paulose CS, Viswanathan M. “Neurobiology of Pyridoxine.” Biochemical Cell Biology. 1988; 66(8):556-561.
2. Kennedy DO, Veasey RC, Watson AW, et al. “Effects of High-Dose B Vitamins on Mood and Psychological Functioning.” Human Psychopharmacology. 2010; 25(4):365-375.
3. Mooney S, Leuendorf JE, Hendrickson C, Hellmann H. “Vitamin B6: A Long Known Compound of Surprising Complexity.” Molecules. 2009; 14(1):329-351.

Newall CA, Anderson LA, Phillipson JD; Herbal Medicine – A Guide for Healthcare Professionals; London UK, The Pharmaceutical Press; 1996

Pharmacology Biochemistry and Behaviour 1982; 17: 65-71

Ingredients

Valerian
Valerian is a natural sedative. It offers important health benefits that range from treatment of anxiety to cures for insomnia. Research shows that Valerian, a potent but safe sleep aid reduces sleep latency (the time it takes to fall asleep). It also improves the quality of sleep.

Valerian is also used for anxiety and psychological stress as it reduces blood pressure, heart rate and feelings of pressure when under tension.

Chamomile
Chamomile is caffeine free and a gentle relaxing and sleep aid. Due to its anti-spasmodic properties it is a muscle relaxant.

Because of its calming and sedative properties, it also induces sleep. This is attributed to an antioxidant it contains called, Apigenin. This antioxidant binds to benzodiazepine receptors in the brain which reduces irritability, decreases anxiety and treats insomnia.

Chrysin the phytochemicals also in chamomile, binds to GABA receptors. This reduces brain activity and produces a calming effect in the central nervous system.

Chamomile can decrease symptoms of mild to moderate generalized anxiety disorder and thwarts panic attacks.

In summary, Chamomile has three main effects on the central nervous system.

1. It regulates neurotransmitter transmission to the brain

The active phytochemicals in chamomile affect the neurotransmitters in the brain.

Monoamine transmitters such as serotonin and dopamine are associated with sleep and mood. Chamomile has a positive effect on these transmitters. This results in improved sleep, enhanced mood, and relief of depression.

2. Binds to GABA receptors

Gaba (gamma aminobutyric acid) is a major inhibitory neurotransmitters in our central nervous system. The overall function of GABA is to inhibit transmission in the brain, calming the nervous activity.

Chrysin the phytochemicals in chamomile also bind with the GABA receptors. This helps reduce brain activity, promotes calmness and results in an overall calming effect on the central nervous system to  induces sleep.

3. Influences Neurohormones

Chamomile assists the neurohormones including Melatonin which is responsible for inducing sleep and regulating sleep-wake cycle.

Magnesium glycinate
The body requires large amounts of magnesium. This mineral is therefore known as a macro-mineral. It has wide-ranging effects in the body and used in over 600 cellular actions in the body.

These include muscle relaxation and influencing certain processes that promote sleep.

Magnesium deficiency is common. A deficiency of this vital mineral can cause tightness of muscles, increased stress, reduced serotonin levels and even sleep complications.

It is essential as a muscle relaxation mineral and a key element in the production of the feel-good chemical serotonin.

Magnesium glycinate also binds with GABA and that leads to anti-anxiety effects. It is therefore used to treat mild depression and stress by improving mood and encouraging healthy sleep habits.

Vitamin B6
Vitamin B6 promotes proper function of the nervous system.

Deficiencies in Vitamin B6 contribute to the chemical imbalances related to depression. With vital roles in the production of dopamine and serotonin, Vitamin B is essential to reduce irritability and depression.

Vitamin B6 coacts with magnesium to promote muscle relaxation. It is specifically recommended at bedtime to help improve sleep.

Research

Volunteers were given an aqueous extract of valerian.

Compared with the placebo, the valerian extract resulted in a statistically significant subjective improvement in time required to fall asleep (more or less difficult than usual), sleep quality (better or worse than usual), and number of night-time awakenings (more or less than usual).

(Leathwood PD, Chauffard F, Heck E, Munoz-Box R: Aqueous extract of valerian root (Valeriana officinalis L.) improves sleep quality in man. Pharmacology, Biochemistry and Behavior 17: 65-71, 1982. [PubMed abstract])

Eight volunteers with mild insomnia (usually had problems falling asleep) were evaluated for the effect of valerian on sleep latency (defined as the first 5-minute period without movement).

Results were based on night-time motion measured by activity meters worn on the wrist and on responses to questionnaires about sleep quality, latency, depth and morning sleepiness.

The test samples were 450mg or 900 mg of an aqueous valerian extract and a placebo.

The 450mg test sample of valerian extract reduced average sleep latency from about 16 to 9 minutes, which is similar to the activity of prescription benzodiazepine medication (used as a sedative or tranquilizer). No statistically significant shortening of sleep latency was seen with the 900-mg test sample.

Evaluation of the questionnaires showed a statistically significant improvement in subjectively measured sleep. The 900-mg test sample increased the sleep improvement but participants noted an increase in sleepiness the next morning.

(Vorbach EU, Gortelmeyer R, Bruning J: Treatment of insomnia: effectiveness and tolerance of a valerian extract [in German]. Psychopharmakotherapie 3: 109-115, 1996.)

Longer-term effects in 121 participants with documented nonorganic insomnia.

Participants received either 600 mg of a standardized commercial preparation of dried valerian root or placebo for 28 days. Several assessment tools were used to evaluate the effectiveness and tolerance of the interventions, including questionnaires on therapeutic effect (given on days 14 and 28), change in sleep patterns (given on day 28), and changes in sleep quality and well-being (given on days 0, 14, and 28).

After 28 days, the group receiving the valerian extract showed a decrease in insomnia symptoms on all the assessment tools compared with the placebo group. The differences in improvement between valerian and placebo increased between the assessments done on days 14 and 28.

(Dorn M: Valerian versus oxazepam: efficacy and tolerability in nonorganic and nonpsychiatric insomniacs: a randomized, double-blind, clinical comparative study [in German]. Forschende Komplementärmedizin und Klassische Naturheilkunde 7: 79-84, 2000. [PubMed abstract])

In a randomized, double-blind study, 75 participants with documented nonorganic insomnia were randomly assigned to receive 600 mg of a standardized commercial valerian extract or 10mg oxazepam (a benzodiazepine medication) for 28 days.

Assessment tools used to evaluate the effectiveness and tolerance of the interventions included validated sleep, mood scale, and anxiety questionnaires as well as sleep rating by a physician (on days 0, 14, and 28).

Treatment result was determined via a 4-step rating scale at the end of the study (day 28). Both groups had the same improvement in sleep quality, but the valerian group reported fewer side effects than did the oxazepam group.

(Donath F, Quispe S, Diefenbach K, Maurer A, Fietze I, Roots I: Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 33: 47-53, 2000. [PubMed abstract])

Researchers evaluated sleep parameters with polysomnographic techniques that monitored sleep stages, sleep latency, and total sleep time to objectively measure sleep quality and stages.

Questionnaires were used for subjective measurement of sleep parameters. Sixteen participants with medically documented nonorganic insomnia were randomly assigned to receive either a single dose and a 14-day administration of 600mg of a standardized commercial preparation of valerian or placebo.

Valerian had no effect on any of the 15 objective or subjective measurements except for a decrease in slow-wave sleep onset (13.5 minutes) compared with placebo (21.3 minutes).

During slow-wave sleep, arousability, skeletal muscle tone, heart rate, blood pressure, and respiratory frequency decreased. Increased time spent in slow-wave sleep may decrease insomnia symptoms. The valerian group reported fewer adverse events than did the placebo group.

(Russo EB: Valerian. In: Handbook of Psychotropic Herbs: A Scientific Analysis of Herbal Remedies in Psychiatric Conditions. Binghamton, NY: Haworth Press, 2001: 95-106.)

Frequently Asked Questions

How does Duo Calm work?

• as an anti-spasmodic
• as a natural sedative
• as a muscle relaxant

Will Duo Calm help me fall sleep?

Yes.

Valerian, a potent but safe sleep aid. It reduces sleep latency. Chamomile because of its calming and sedative properties also promotes sleep.

Will Duo Calm induce morning drowsiness?  

There is no evidence of residual or “hangover” effects. Duo calm promotes a natural and refreshing sleep.

Can I take it when I am anxious?

Duo Calm supports well-being and balance during times of stress.

Will Duo Calm help me calm down?

Yes.

It is a relief from pressure often caused by the stresses and strains of modern living.

Valerian is also useful for times of anxiety and psychological stress as it reduces blood pressure, heart rate, and feelings of pressure when under tension.

Magnesium and Vitamin B6 are essentially important during these periods. These ingredients support the healthy functioning of the nervous system.

Will I get addicted to it?

No.

The product in itself is not habit-forming.

As with all sleep medicines they have the potential for causing dependence. In the large majority of cases with Schedule 0 Nutritional Substances, this is usually psychological, not physical.

Duo Calm is however best used as a temporary relief of sleep or stress disturbances.

How old do you have to be to take it?

Duo Calm should not be taken by anyone under the age of 17.

Can I take it during the day to boost my mood or will it put me to sleep? 

It is preferable not to use Duo Calm during the day unless to promote calmness or induce sleep; and only if an individual is not undertaking serious physical or mental activity. Avoid using the product if you operate heavy machinery or drive long distances.

To note, most often sleeping during the day is not part of a person’s natural circadian rhythm.

If you use Duo Calm during the day, limit the length of your sleep so that you can maintain healthy night time sleep routines.

*Depending on the requirement of rest needed during the day, short 15-20 minute naps are also great options.

Can I use Duo Calm daily?

The ingredients in Duo Calm are not habit forming. The product can be used continuously for extended periods of time.

What is the maximum number of Duo Calm capsules I can use each day?

Do not exceed more than 2 capsules per single dose, with a maximum of 2 divided doses per day.

How long before the onset of sleep?

30-45 minutes.

Does Duo Calm have clinical research backing to support its claims?

Duo Calm is supported by a team of clinical researchers and doctors. It is authenticated by clinical evidence and each of its ingredients has proven health benefits. All products developed by Fusion Laboratories conform to the stringent input, processing and quality control criteria of the legislative authorities within the countries in which they are marketed.

Is Duo Calm safe and are there any side effects?

Duo Calm is completely safe and does not have any known side effects. It has a well-established safety profile. Fusion Laboratories manufactures the product under the Good Manufacturing Practices (GMP) standards in a fully controlled facility. This ensures purity, stability of its ingredients and accuracy of the final product. If, for any reason, Duo Calm does not meet stringent pharmaceutical standards, the product is not approved for release from our facility.

If you suffer from a chronic medical condition use this product under the supervision of your healthcare practitioner.

How does a general sleeping tablet work?

There are several different types of prescription sleeping pills, classified as sedative hypnotics. In general, these medications act by working on receptors in the brain to slow down the nervous system. Some medications are used more for inducing sleep, while others are used for staying asleep.

Why choose Duo Calm over other sleep supplements?

• Duo Calm is herbal.
• Duo Calm induces both sleep and promotes a feeling of calmness.
• Fusion Laboratories sources the highest quality ingredients and uses the most advanced technology and research to develop its products.
• Duo Calm has superior product formulation. Its smart and balanced formula is specially designed to allow for optimal absorption, efficacy and enhanced sleep.
• None of the ingredients have been tested on animals.
• Fusion Labs does not use artificial flavourants or preservatives.