Note - The product information found within this database originates from organizations not subject to the Official Languages Act and is available in the language in which it was written and submitted to Health Canada.

Note - The market status of a product is now available in the LNHPD and identifies if a product is "marketed" or "not marketed" in Canada. Product licence holders may voluntarily provide the Natural and Non-Prescription Health Products Directorate (NNHPD) with information about whether their product is currently available to Canadian consumers. Where no information has been provided, the default status is "not marketed". The "current status" field remains unaffected and will continue to indicate the status of the product licence (i.e., active, discontinued, stop sale, cancelled, or suspended). Note that where a licence has been suspended, cancelled or under stop sale, the product cannot be legally sold in Canada.

Product licence holders - if you wish to update a product's market status, you are invited to complete the Natural Health Products Market Notification Web Form. As with all other notifications, there is no current service standard. The NNHPD will process the market status update as soon as feasible, based on its available resources. As a reminder, market notification is voluntary; therefore, a licence holder is not required to wait for the LNHPD to be updated before a licensed product is sold in Canada. As such, products that are identified in the LNHPD as "not marketed" may still be sold in Canada.

New search

Natural Product Number (NPN):

80108182

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Sleep 10-5mg ;
Sleep8 Plus

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

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 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 re-set the body's sleep-wake cycle (aspect of the circadian rhythm). 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. Lemon Balm is traditionally used in Herbal Medicine as a sleep aid.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner if sleeplessness persists for more than 4 weeks (chronic insomnia). Consult a health care practitioner if symptoms persist or worsen. Avoid taking with products that cause drowsiness. Consult a health care practitioner 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 prior to use if you have cardiovascular, immune, liver or chronic kidney disease, hormonal or seizure disorders, asthma, depression and/or related diseases, diabetes, low blood sugar, or migraine.

Contra-Indications 

Do not use this product if you are pregnant or breastfeeding. Do not drive or use machinery for 5 hours after taking melatonin. Do not use with alcohol.

Known Adverse Reactions 

Stop use if hypersensitivity/allergy occurs. Stop use if you experience headache, confusion, or nausea. 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	70.0 mg	4.0 : 1.0 DHE: 280.0 mg Dry	3.5   % Bioflavonoids
L-Theanine	100.0 mg
Matricaria chamomilla	70.0 mg	20.0 : 1.0 DHE: 1400.0 mg Dry	5.0   % Bioflavonoids
Melissa officinalis	50.0 mg	10.0 : 1.0 DHE: 500.0 mg Dry
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide	5.0 mg
Nepeta cataria	15.0 mg
Panax notoginseng	50.0 mg	8.0 : 1.0 DHE: 400.0 mg Dry
Passiflora incarnata	70.0 mg	9.0 : 1.0 DHE: 630.0 mg Dry	4.0   % Bioflavonoids
Scutellaria lateriflora	70.0 mg	10.0 : 1.0 DHE: 700.0 mg Dry	12.5   % Bioflavonoids
gamma-Aminobutyric acid	150.0 mg

List of non-medicinal ingredients:

• Hypromellose
• Magnesium stearate
• Purified water
• Silicon dioxide

Date of licensing:

2021-02-15

Revised date of licence:

2022-11-23