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Drugs and Health Products

Monograph: Passionflower

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Date: 2008-03-20

NHPID Name

Passiflora incarnata (USDA 2008)

Proper Name(s)

Passiflora incarnata L. (Passifloraceae) ( USDA 2008 , EMEA 2007 )

Common Name(s)

Passionflower ( USDA 2008 , EMEA 2007 )

Source Material

Herb top ( EMEA 2007 )

Route Of Administration

Oral

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to mental stress)  (EMEA 2007)

Dose(s)

Adults and adolescents 13 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.25 - 8 Grams per day, dried herb tops

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

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if sleeplessness persists continuously for more than 3 weeks (chronic insomnia)  (Berardi et al. 2002, DiPiro et al. 2002)
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding  (EMEA 2007)
  • Consumption with alcohol, other medications or natural health products with sedative properties is not recommended  (Brinker 2010, EMEA 2007)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
  • Hypersensitivity (e.g. allergy) has been known to occur; in which case, discontinue use  (EMEA 2007)
  • Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness  (EMEA 2007)

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Passion Flower Monograph published in the British or the European Pharmacopoeias.

References cited

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: a pathophysiologic approach, 5th edition. New York (NY): The McGraw-Hill Companies, Inc.; 2002.
  • EMEA 2007. European Medicines Agency. Community Monograph on. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 31 October 2007. [Accessed 2008-03-20]. Available from: http://www.emea.europa.eu/pdfs/human/hmpc/passiflorae_herba/23096206enfin.pdf
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References reviewed

ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use (EMEA 2007)

Dried aerial parts:

0.5-2 g, 1-4 times per day

Infusion:

1-2 g dried aerial parts, 1-4 times per day

Directions for use:

Pour 150 ml of boiling water on dried aerial parts and steep for 10 minutes.

Fluidextract:

  • 0.5-2 g dried equivalent, 1-4 times per day
    (1:1, 25% alcohol, 0.5-2 ml)
  • 2 g dried equivalent, 1-3 times per day
    (1:1, 70% alcohol, 2 ml)

Tincture:

  • 0.25-0.5 g dried equivalent, 1-4 times per day
    (1:8, 25% alcohol, 2-4 ml)
  • 0.25 g dried equivalent, 1-3 times per day
    (1:8, 45% alcohol, 2 ml)