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Natural Product Number (NPN):

80031162

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Sleep 8

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Helps increase the total sleep time in people suffering from sleep restriction or altered sleep schedule; helps relieve the daytime fatigue associated with jet lag; helps to reduce the time it takes to fall asleep in people with delayed sleep phase syndrome; helps re-set the body's sleep-wake cycle.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner prior to use if you have depression, a hormonal disorder, diabetes, liver disease, kidney disease, cancer, endometriosis, cerebral palsy, seizure disorders, migraine, hypertension or if you are taking blood pressure, blood thinning, antidepressant or sedative/hypnotic medications. Consult a health care practitioner if symptoms worsen or persist continuously for more than 3 weeks (chronic insomnia). Exercise caution if involved in activities requiring mental alertness.

Contra-Indications 

Do not drive or use machinery for 5 hours after taking. Consumption with alcohol, other medications, and/or natural products with sedative properties is not recommended. Do not use if you are pregnant, breastfeeding, taking immunosuppressive drugs or cyclosporine, or allergic to plants of the Asteraceae/Compositae/Daisy family.

Known Adverse Reactions 

Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use. Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Humulus lupulus	35.0 mg	4 : 1 DHE: 140 mg	3.5   % Flavonoids
Magnesium	20.0 mg
Matricaria recutita	35.0 mg	20 : 1 DHE: 700 mg	5.0   % Flavonoids
N-acetyl-5-methoxytryptamine	500.0 mcg
Nepeta cataria	15.0 mg
Passiflora incarnata	35.0 mg	8-10 : 1 DHE: 280-350 mg	4.0   % Flavonoids
Saponins	25.0 mg
Scutellaria lateriflora	35.0 mg	10 : 1 DHE: 350 mg	12.5   % Flavonoids

List of non-medicinal ingredients:

• Hypromellose
• Magnesium Stearate
• Purified water
• Silicon dioxide

Date of licensing:

2012-03-30

Revised date of licence: