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

Date

July 31, 2018

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

Table 1.Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Common name(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: O' Neil et al. 2013, Martindale 2012, Buscemi et al. 2004; Common name: O' Neil et al. 2013, Buscemi et al. 2004; Source material: O' Neil et al. 2013.

Route of administration

Sublingual (Buscemi et al. 2004)

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Dose(s)

Subpopulation(s)

Adults 18 years and older (IOM 2004)

Quantity(ies)

All uses except jet lag

0.1-10 milligrams of melatonin, per day (Brzezinski et al. 2005; IOM 2004; Andrade et al. 2001; Kayumov et al. 2001; Koda-Kimble 2001; Smits et al. 2001; Zhdanova et al. 2001; Citera et al. 2000; Shamir et al. 2000; Brusco et al. 1999; Jean-Louis et al. 1999; Matsumoto 1999; Dolberg et al. 1998; Lewy et al. 1998; Attenburrow et al. 1996; Garfinkel 1995; Haimov et al. 1995; Tzischinsky and Lavie 1994; Dollins et al. 1993; 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 2009; Suhner et al. 1998a).

Direction(s) for use

All uses except jet lag

Take once a day, at or before bedtime (Murray et al. 2006; Kayumov et al. 2001; Zhdanoya et al. 2001).

Jet lag

Take once a day at bedtime, while travelling, and at destination until adapted to the new time zone/or daily pattern (Brown et al. 2009; Herxheimer and Petrie 2009).

Duration(s) of use

All Products

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks (Buscemi et al. 2004; IOM 2004).

Risk information

Caution(s) and warning(s)

All uses except jet lag

Consult 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).

All uses

Contraindication(s)

Known adverse reaction(s)

Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2009).

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

No statement required.

Specifications

References cited

References reviewed