Monograph: Passionflower

Date: 2018-12-18

NHPID name

Passiflora incarnata ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Passiflora incarnata ( USDA 2008 , EMEA 2007 )

Common name(s)

• Apricot-vine
• Maypop
• Maypop passionflower
• 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 (during times of mental stress).
• (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative).  (EMEA 2007)
• (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) and as a sleep aid (during times of mental stress).

Dose(s)

Adults:

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):

• Avoid taking with alcohol or products that cause drowsiness.
• Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.  (Brinker 2010, EMEA 2007)
• Consulter un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin si les symptômes persistent ou s'aggravent.  (EMEA 2007)
• Consult your 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)

Contraindication(s): No statement is required Known Adverse Reaction(s):

• Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness.  (EMEA 2007)
• Stop use if hypersensitivity/allergy occurs.  (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

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)