β-Rested Prescribing Information

A pharmacist is handing a written prescription to a patient for a bottle of β-Rested, which is on the counter next to them.

 

 

PRESCRIBING INFORMATION for β-RESTED

These highlights do not include all the information needed to use β-RESTED safely and effectively. See full prescribing information for β-RESTED.

β-RESTED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 400mg Valerian (Extract 0.8% Valerenic Acid), 100mg 5-HTP (Griffonia Simplicifolia), Terpene Complex. Each softgel of β-RESTED contains the following inactive ingredients: MCT Oil, Gelatin. 


----------------------------INDICATIONS AND USAGE ----------------------------

β-RESTED is an herbal-based sedative that reduces the time it takes to fall asleep while naturally initiating the natural cycles of sleep. (1.1)

----------------------- DOSAGE AND ADMINISTRATION -----------------------

  • Four softgels of β-RESTED taken orally once forty five mins before sleep. (2.1)

  • WARNING: SELECTIVE CYTOCHROME P450 CYP INHIBITION.

1 INDICATIONS AND USAGE

1.1 β-RESTED is indicated for patients having trouble falling asleep or getting adequate sleep due to nighttime emotional and cognitive hyperactivity. 

2  DOSAGE AND ADMINISTRATION

    • 2.1  General Dosing Information
    • Four softgels one hour before bed with food.
    • 2.2  Avoid coadministration with SSRIs, GABA RECEPTOR AGONISTS.  
    • 2.3 Avoid coadministration with CNS Depressants

3  DOSAGE FORMS AND STRENGTHS

  • β-RESTED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 400mg Valerian (Extract 0.8% Valerenic Acid), 100mg 5-HTP (Griffonia Simplicifolia)

4  CONTRAINDICATIONS

    • 4.1  A History of Depression, Suicidal Ideation. CNS Depressants. 

5  WARNINGS AND PRECAUTIONS

    • 5.1  Competitive Inhibition of CYP2C, CYP3A, SEDATIVE

6  ADVERSE REACTIONS

                  6.1 CLINICAL TRIALS 

 7 DRUG INTERACTIONS

Unknown. Avoid coadministration with SSRIs, MAOIs and CNS Depressants (GABAergic Agonists). 

To report SUSPECTED ADVERSE REACTIONS, contact Synergy BioNaturals., at (480)-744-5300, EMAIL drspero@synergybionaturals.com  

8 PREGNANCY

  •      8.1  Nursing Mothers

9  OVERDOSAGE

10  DESCRIPTION

10.1 COMPOUND SUMMARY

11  CLINICAL PHARMACOLOGY

         11.1  Mechanism of Action

12 CLINICAL STUDIES

13  HOW SUPPLIED/STORAGE AND HANDLING

14  PATIENT COUNSELING INFORMATION

15  BENEFITS AND RISKS

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 β-RESTED is an herbal-based sedative that reduces the time it takes to fall asleep while naturally initiating the natural cycles of sleep.

2 DOSAGE AND ADMINISTRATION

  • 2.1  General Dosing Information
    Four softgels of β-RESTED one hour before bed with food.  

β-RESTED has been studied only as an addition to a healthy lifestyle. There is limited clinical experience with other prescription drugs.

3 DOSAGE FORMS AND STRENGTHS

β-RESTED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 400mg Valerian (Extract 0.8% Valerenic Acid), 100mg 5-HTP (Griffonia Simplicifolia), Terpene Complex. Each softgel of β-RESTED contains the following inactive ingredients: MCT Oil, Gelatin (per serving), are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

4 CONTRAINDICATIONS

4.1 β-RESTED is contraindicated in patients with a history of Depression, Suicidal Ideation. CNS Depressants.

Discontinue β-RESTED in patients who experience nausea, dizziness, or GI cramps.

5 WARNINGS AND PRECAUTIONS

5.1 AVOID TAKING WITH CNS DEPRESSANTS (GABAergic AGONISTS. SEROTONERGIC AGONISTS (SSRIs) and MAOIs. 

β-RESTED with 5.1 together increase the risk of Adverse Reactions.

5.2 STRONG CYP INHIBITION

Competitive Inhibition of CYP2C and CYP3A inhibitors can increase the effectiveness of other prescription drugs.  

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

More studies are needed to understand the pharmacodynamics of the ingredients in β-RESTED with other prescription medications. 

7 DRUG INTERACTIONS

7.1 β-RESTED contains CBD, which has been shown to inhibit CYP2C and CYP3A drug-metabolizing enzymes.  

8 Pregnancy

There are no clinical studies of β-CALMED to determine its use during pregnancy. 

8.1 Nursing Mothers

It is unknown whether the ingredients in β-RESTED are excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, it's not recommended to prescribe β-RESTED to nursing mothers.

9 OVERDOSAGE

There is little risk of overdose. But more clinical studies are needed to determine overdose risk. 

10 DESCRIPTION

β-RESTED contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 400mg Valerian (Extract 0.8% Valerenic Acid), 100mg 5-HTP (Griffonia Simplicifolia)

10.1 COMPOUND SUMMARY


CBD

cannabidiol

(-)-Cannabidiol

(-)-trans-Cannabidiol

CBD

314.5 g/mol

C21H30O2

L-Theanine

L-Theanine

N-Ethyl-L-glutamine

174.2 g/mol

C7H14N2O3

Valerian

Valerenic acid

234.33 g/mol

C15H22O2

5-HTP

5-Hydroxytryptophan

220.22 g/mol

C11H12N2O3

MYRCENE

beta-Myrcene

136.23 g/mol

C10H16


Limonene

Dipentene

136.23 g/mol

C10H16

11 CLINICAL PHARMACOLOGY

11.1 Mechanism of Action

β-RESTED

CBD Broad Spectrum Cannabidiol inhibits the degradation of Anandamide, an endogenous cannabinoid involved in the regulation of pain, mood, and cognition. CBD prevents the breakdown of the endocannabinoid Anandamide by binding with fatty acid-binding protein FABP, which solubilizes and transports endocannabinoids such as Anandamide into the cell where it’s broken down by the enzyme fatty acid amide hydrolase FAAH. CBD has been shown to inhibit the uptake of the neuromodulator adenosine leading to suppression in arousal and onset of sleep. 

Suntheanine®: L-Theanine is structurally similar to glutamic acid, one of the primary excitatory neurotransmitters in the central nervous system.  L-Theanine crosses the blood-brain barrier, where it binds to glutamate receptors, inhibiting excitatory activity in the brain. L-Theaninae increases the production of the inhibitory neurotransmitter GABA which results in a greater movement of chloride into key neurons involved in insomnia and depression, creating a hyperpolarized state where the negatively charged cells become less responsive to excitatory potentials.  Suntheanine is the most bioavailable form of the naturally occurring amino acid L-Theanine, delivering the pharmacologically active (L) isomer, which is well-keyed in neurochemical structures.   

Valerian: Valerenic acid interacts with GABAA neurons similarly to action of the benzodiazepines, by binding to specific subunits on the GABAA receptor complex. Stimulation of GABAA receptors directly opens chloride channels, thereby producing neural inhibition. Valerian increases GABA levels and GABA neurotransmission by stimulating glutamic acid decarboxylase (GAD). Glutamic acid decarboxylase is the rate-limiting enzyme in the synthesis of γ-aminobutyric acid (GABA). Valerian inhibits GABA transaminase activity, the enzyme responsible for breaking down GABA.

Myrcene is a natural muscle relaxant that induces the “couch-lock” sedative effect when synergized with other terpenes such as Limonene.  

Limonene synergizes with the terpene myrcene increasing its anti-inflammatory, anti-oxidative, and anti-proliferative benefits.


12 CLINICAL STUDIES

Visit: www.synergybionaturals.com, or request a copy of clinical studies at thomas@synergybionaturals.com

13 HOW SUPPLIED/STORAGE AND HANDLING

β-RESTED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 400mg Valerian (Extract 0.8% Valerenic Acid), 100mg 5-HTP (Griffonia Simplicifolia), are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

They are supplied as follows:

465077778942 UPC 120 softgels
Storage of β-RESTED softgels
Store at 20-25°C (68-77°F), transfer of β-RESTED is permitted 15-30°C (between 59-86°F). Store softgels in the original package with the bottle tightly closed. Keep the cotton in the bottle to protect from moisture.

14 PATIENT COUNSELING INFORMATION

Advise the patient to read the Suggested Use on the back of the bottle or visit www.SynergyBioNaturals.com for more information.

15 BENEFITS AND RISKS

Adumbrate the uses and potential side effects of of β-RESTED. Tell patients to take β-RESTED exactly as suggested on the bottle. Instruct patients to inform physicians that taking β-RESTED with CNS Depressants, MAOIs, and Serotonergic and GABAergic Agonists is not advised. 


Tell patients to list all medications, over-the-counter medications, or dietary supplements they are taking or plan to take so that the physician understands possible side effects or interactions.

Manufactured by: Synergy BioNaturals 4742 N. 24th St. Suite 300 Phoenix, AZ 85016. Their respective companies own the trademarks depicted herein.

Copyright © 2020 Synergy BioNaturals LLC., All rights reserved.