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Natural Product Number (NPN):

80096859

Market status:

Marketed

Licence Status:

Active

Brand name(s):

SLEEP-GREAT ;
SLEEP-GREAT SLEEP FORMULA

Licence holder:

Healthology International Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Used in Herbal Medicine as a sleep aid (during times of mental stress). Used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative). Helps to temporarily promote relaxation. Helps increase the total sleep time (aspect of sleep quality) in people suffering from sleep restriction or altered sleep schedule (e.g. shift-work and jet lag). Helps re-set the body's sleep-wake cycle (aspect of the circadian rhythm). Helps to prevent and/or reduce the effects of jet lag/minimize jet lag (e.g. daytime fatigue, sleep disturbance) (for people travelling by plane easterly across two or more time zones/if flying east over two or more time zones). Helps to speed up/ reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people who fall asleep slowly/ with delayed sleep phase disorder.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen. Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if you experience any of the following symptoms within a few hours after taking this product: changes in mental state such as restlessness or confusion, increased heart rate, enlarged pupils, loss of muscle coordination, sweating, shivering and/or gastrointestinal symptoms such as nausea, vomiting, diarrhea. Avoid taking with alcohol or products that increase drowsiness. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking medications for seizure, blood pressure, to suppress the immune system (immunosuppressive medications), to affect mental state or increase sedation, steroids or blood thinners. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have cardiovascular, immune, liver or chronic kidney disease, hormonal or seizure disorders, asthma, depression, diabetes, low blood sugar, or migraine. All uses except Jet lag: Consult your health care practitioner if sleeplessness persists for more than 3 weeks (chronic insomnia). Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking carbidopa or drugs/supplements with serotonergic activity. These may include, but are not limited to, L-tryptophan, Sadenosylmethionine (SAMe), St. John's wort, antidepressants, pain killers, over the counter cough and cold medication containing dextromethorphan, anti-nausea medication and anti-migraine medication Stop use and consult a health care practitioner/health care provider/health care professional/ doctor/physician if you show signs of weakness, oral ulcers, abdominal pain accompanied by severe muscle pain or if you experience skin change.

Consult a health care practitioner prior to use if you have had recent surgery or have upcoming surgery. Keep out of reach of children.

Contra-Indications 

Do not use this product if you have scleroderma. Do not use this product if you are pregnant or breastfeeding.

Known Adverse Reactions 

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness. Some people may experience diarrhea, nausea, vomiting and abdominal pain. Stop use if allergy occurs or if you experience headache, confusion, or nausea.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Eriobotrya japonica	65.0 mg	15 : 1 DHE: 975 mg Dry	25.0   % Ursolic acid
L-5-Hydroxytryptophan	50.0 mg
L-Theanine	200.0 mg
L-Tryptophan	50.0 mg
N-Acetyl-5-methoxytryptamine	1.5 mg
Passiflora incarnata	40.0 mg	10 : 1 DHE: 400 mg Dry
Schisandra chinensis	25.0 mg	10 : 1 DHE: 250 mg Dry
Scutellaria lateriflora	50.0 mg	4 : 1 DHE: 200 mg Dry
Valeriana officinalis	50.0 mg	4 : 1 DHE: 200 mg Dry	0.8   % valerenic acid
gamma-Aminobutyric acid	50.0 mg

List of non-medicinal ingredients:

• Hypromellose
• Oryza sativa (Rice) hull powder

Date of licensing:

2020-01-28

Revised date of licence:

2021-08-30