MELATONIN - Sublingual

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For Melatonin products with an oral route of administration, please use the Melatonin-oral monograph.

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

Notes

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

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

Sublingual

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 sublingual 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)

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; Jorgensen and Witting 1998; Sack et al. 1997; Attenburrow et al. 1996; Zhdanova et al. 1995; Garfinkel 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

All uses

Take as needed, 10 to 30 minutes before bedtime. Place under the tongue until it is dissolved (Abdellah et al. 2023; Bartoli et al. 2012; Naguib and Samarkandi 1999; Jorgensen and Witting 1998).

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

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

EXAMPLE OF PRODUCT FACTS:

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

Product Facts Table

References cited

References reviewed