Monograph: 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 (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-07-31

NHPID name

Melatonin ( O'Neil et al. 2012 )

Proper name(s)

Common name(s)

Source material

Melatonin (Unavailable)

Route Of administration

Sublingual ( Buscemi et al. 2004 )

Dosage form(s)

Those pharmaceutical dosage forms suited to sublingual administration.

Use(s) or purpose(s)

Statement(s) to the effect of:




1 Day per day

Directions for use:
  • Take once a day, at or before bedtime.
  • Take once a day at bedtime, while travelling, and at destination until adapted to the new time zone/or daily pattern.

See Appendix 1 for examples of dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks.

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): Known Adverse Reaction(s): Stop use if allergy occurs or if you experience headache, confusion, or nausea.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.


References cited

References reviewed

Appendix 1:

Examples of dosage preparations, frequencies of use and directions for use

All uses except jet lag:

0.1-10 mg, 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)

Direction for use

All uses:

Jet lag:

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

Direction for use