What is it used for?
(Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) [Source note 2].
(Traditionally) used in Herbal Medicine as a sleep aid (during times of mental stress) [Source note 3].
The above claims can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Traditionally used in Herbal Medicine to help relieve restlessness and/or nervousness and as a sleep aid during times of mental stress).
For multi-ingredient products:
To prevent the product from being represented as a "traditional medicine," any indicated traditional use claim must refer to the specific active ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. Passionflower is traditionally used in Herbal Medicine as a sleep aid during times of mental stress).
When ALL of the active ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.
What this guide covers
The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant on the label.
Who does this guide cover?
Adolescents 12-17 years and Adults 18 years and older [Source note 4]
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Quantities
Methods of preparation: Dry, Powdered, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
0.25 - 8 grams of dried herb top, per day [Source note 5]
Methods of preparation: Non-Standardized Aqueous Extracts (Dry extract, Decoction, Infusion)
1 - 8 grams of dried herb top, per day [Source note 6].
How is it used?
Sleep aid
Take (1 hour) before bedtime, as needed [Source note 7].
Restlessness/nervousness
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
Sleep aid
Ask a healthcare professional if sleeplessness persists for more than 4 weeks (chronic insomnia) (Berardi et al. 2002: DiPiro et al. 2002).
Restlessness/nervousness
Ask a healthcare professional if symptoms persist or worsen.
All uses
Ask a healthcare professional/ physician before use if you are pregnant or breastfeeding [Source note 8].
When using this product avoid taking with alcohol or products that cause drowsiness [Source note 9].
When using this product exercise caution if you drive or use machinery as you may experience drowsiness [Source note 10].
When should it be avoided?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Possible side effects
Stop use if hypersensitivity/allergy occurs [Source note 11].
Storage
Must be established in accordance with the requirements described in the applicable product regulations .
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|
| Passiflora incarnata |
| Passiflora incarnata | Herb top | Dry |
References: Proper name: USDA 2023, EMA 2014; Common names: USDA 2023, EMA 2014; Source information: EMA 2014.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- November 29, 2024
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
Taking a medication too?
Explore our supplement–medication interaction checker. Its coverage and review status are shown with the results; a missing finding does not establish that a combination is safe.