MELATONIN - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

• Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Rules for the application of this monograph when combined with other monographs:

• Products containing melatonin must not indicate any uses or purposes related to the maintenance/support of good/general health.
• Products providing a quantity of melatonin that meets the minimum therapeutic dose must indicate a use or purpose associated with melatonin.

Date

April 26, 2024

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information

Proper name(s)	Common name(s)	Source information
		Source ingredient(s)	Preparation(s)
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide N-Acetyl-5-methoxytryptamine	Melatonin Pineal hormone	Melatonin	Synthetic

References: Proper names: RSC 2023; Buscemi et al. 2004; Common names: RSC 2023; Buscemi et al. 2004; Source information: RSC 2023.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications. Note that this list does not include prolonged-release, extended-release or delayed-release dosage forms.

Use(s) or Purpose(s)

• (Used as a) sleep aid (to help promote sleep) (Costello et al. 2014; Wyatt et al. 2006; Brzezinski et al. 2005).
• 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) (Zhdanova et al. 2001; Brusco et al. 1999; Sanders et al. 1999; Skene et al. 1999; Garfinkel et al. 1995; Sack et al. 1991).
• Helps (to) prevent and/or reduce the effects of jet lag/minimize jet lag (e.g. daytime fatigue, sleep disturbance) (for people/if travelling by plane easterly across two or more time zones/flying east over two or more time zones) (Brown et al. 2009; Herxheimer and Petrie 2002; Suhner et al. 1998a; Petrie et al. 1993; Claustrat et al. 1992; Petrie et al. 1989).
• 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 (van Geijlswijk et al. 2010).
• Helps (to) re-set the body's sleep-wake cycle (aspect of the circadian rhythm) (van Geijlswijk et al. 2010; Kunz et al. 2004; Sack et al. 2000).

Note

The above claims can be combined on the product label (e.g. Helps re-set the body's sleep-wake cycle (aspect of the circadian rhythm) and increase the total sleep time (aspect of sleep quality) in people suffering from sleep restriction or altered sleep schedule).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

All uses except jet lag

0.1-10 milligrams of melatonin, per day (Brzezinski et al. 2005; IOM 2004; Kayumov et al. 2001; Koda-Kimble 2001; Zhdanova et al. 2001; Brusco et al. 1999; Jean-Louis et al. 1999; Matsumoto 1999; Sack et al. 1997; Attenburrow et al. 1996; Garfinkel 1995; Zhdanova et al. 1995; Tzischinsky and Lavie 1994; Dollins et al. 1994; Dahlitz et al. 1991; James et al. 1987).

Jet lag

0.5-10 milligrams of melatonin, per day (Brown et al. 2009; Herxheimer and Petrie 2002; Suhner et al. 1998a).

Direction(s) for use

Take as needed, 30 to 60 minutes before bedtime (Andersen et al. 2016; Zhdanova et al. 2001, 1995; Nave et al. 1995).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All uses

• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
• Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
• When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
• When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
• Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).

Contraindication(s)

Do not use if you are pregnant or breastfeeding (IOM 2004).

Known adverse reaction(s)

Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient must comply with the requirements outlined in the NHPID.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

References Cited

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References Reviewed

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