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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.



December 18, 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)
Proper name(s) Part(s) Preparation

Passiflora incarnata

  • Apricot-vine
  • Maypop
  • Maypop passionflower
  • Passionflower

Passiflora incarnata

Herb top


References: Proper name: USDA 2018, EMA 2014; Common names: USDA 2018, EMA 2014; Source material: EMA 2014.

Route of Administration


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:

(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) and as a sleep aid (during times of mental stress) (EMA 2014; Godfrey and Saunders 2010; Wichtl 2004; Blumenthal et al. 2000; Felter and Lloyd 1983).


Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".



Adolescents 12-17 years and Adults 18 years and older (EMA 2014)


Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

0.25 - 8 grams of dried herb top, per day (EMA 2014)

Methods of preparation: Non-Standardised Aqueous Extracts (Dry extract, Decoction, Infusion)

1 - 8 grams of dried herb top, per day (EMA 2014).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep aid

Consult a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002: DiPiro et al. 2002).

All products


No statement required.

Known adverse reaction(s)

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.


References Cited

References Reviewed