Evigrade

Passionflower (Passiflora incarnata, aerial parts)

Herbal sedative, EMA HMPC traditional herbal medicinal product

ATC code: N05CX-PASSIFLORA

Brand names: NOW Passion Flower, Gaia Herbs Passionflower, Nature's Way Passion Flower, Solgar Passion Flower Extract

Updated · Methodology

Indications

C

Stress and anxiety

Adjunct

Passionflower is used for mild nervous tension and transient anxiety. HMPC in 2014 confirmed traditional-use status based on 30 years of European practice. The Miyasaka Cochrane review 2007 pooled 2 RCTs in GAD and preoperative anxiety – conclusion: data are too sparse to recommend passionflower as monotherapy for anxiety disorders. Several small comparator trials showed effect comparable to low-dose oxazepam in GAD, but methodology was weak and samples small. CG113 (2019) does not mention passionflower. For episodic anxiety before dental procedures or public speaking a short course of 250–500 mg of extract is acceptable. If passionflower was offered for diagnosed anxiety disorder or panic attacks as a replacement for psychotherapy and SSRIs, consider seeking a second opinion.

ICD-10: F41.9 · ICD-11: 6B0Z

D

Insomnia and sleep disorders

Adjunct

Passionflower is positioned as a sleep aid, often combined with valerian and lemon balm. HMPC recognises use for «transient sleep disturbance linked to nervous tension». Passionflower monotherapy RCTs in insomnia are few: one study with a 2 g/day infusion showed improvement in subjective sleep quality, but the sample was 41 people. The 2021 guideline does not include passionflower. For mild episodic insomnia a short course is acceptable. For chronic insomnia the evidence base of CBT-I is substantially stronger.

ICD-10: G47.0 · ICD-11: 7A00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Panic disorder

Not recommended

Passionflower is actively marketed for panic attacks and panic disorder. Clinical data for this diagnosis are very limited: one small GAD RCT is methodologically weak, and no separate RCT in panic disorder exists. HMPC does not include «panic disorder» in the traditional-use indication. CG113 (2019) recommends CBT and SSRIs for panic disorder, not herbal products. Marketing promises to replace benzodiazepines or antidepressants with passionflower are not supported by evidence. Panic disorder is a serious diagnosis with effective treatment. If passionflower was prescribed in place of standard therapy, consider seeking a second opinion.

ICD-10: F41.0 · ICD-11: 6B01

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Passionflower aerial parts contain flavonoids (vitexin, isovitexin, orientin), maltol, harman alkaloids and essential oils. Flavonoids bind the benzodiazepine site of the GABA-A receptor and potentiate GABA signalling – the effect is much weaker than benzodiazepines. Maltol and harman alkaloids may inhibit monoamine oxidase in vitro, but clinical relevance of this inhibition in humans is not proven. HMPC in 2014 classified passionflower herb extract as a traditional herbal medicinal product based on 30 years of use, without large RCT confirmation. Active flavonoid bioavailability is low and varies between manufacturers.

Safety

Contraindications

  • Hypersensitivity to passionflower
  • Age under 12 (EMA HMPC – no data)
  • Pregnancy and lactation
  • Concurrent use with MAOIs – theoretical risk

Serious adverse effects

  • Potentiation of alcohol, benzodiazepines and opioids
  • Isolated case reports of QT prolongation at very high doses

Common adverse effects

  • Drowsiness
  • Dizziness
  • Confusion at over-dosing
  • Nausea

Pregnancy: can you take Passionflower (Passiflora incarnata, aerial parts)?

Safety data in pregnancy are insufficient. Harman alkaloids may theoretically increase uterine tone. EMA HMPC does not recommend use in pregnancy due to lack of adequate studies. AEMPS classifies the product as a traditional herbal medicinal product without a pregnancy indication.

Breastfeeding: can you take Passionflower (Passiflora incarnata, aerial parts)?

Data on transfer of passionflower constituents into human milk are lacking. EMA HMPC does not recommend use during lactation.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Passionflower (Passiflora incarnata, aerial parts) used for?

Passionflower (Passiflora incarnata, aerial parts) is evaluated for the following indications with varying evidence strength: Stress and anxiety (evidence tier C), Panic disorder (evidence tier D), Insomnia and sleep disorders (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Passionflower (Passiflora incarnata, aerial parts)?

Common side effects of Passionflower (Passiflora incarnata, aerial parts) (≥ 1 in 100): Drowsiness, Dizziness, Confusion at over-dosing, Nausea. See the Safety section for uncommon and serious reactions.

Is Passionflower (Passiflora incarnata, aerial parts) safe during pregnancy?

Safety data in pregnancy are insufficient. Harman alkaloids may theoretically increase uterine tone. EMA HMPC does not recommend use in pregnancy due to lack of adequate studies. AEMPS classifies the product as a traditional herbal medicinal product without a pregnancy indication.

Is Passionflower (Passiflora incarnata, aerial parts) compatible with breastfeeding?

Data on transfer of passionflower constituents into human milk are lacking. EMA HMPC does not recommend use during lactation.

Who should not take Passionflower (Passiflora incarnata, aerial parts)?

Passionflower (Passiflora incarnata, aerial parts) is contraindicated in: Hypersensitivity to passionflower; Age under 12 (EMA HMPC – no data); Pregnancy and lactation; Concurrent use with MAOIs – theoretical risk. Full list in the Safety section.

Other drugs in this group

Phenazepam, Phenibut, Pimavanserin, Pimozide, Risperidone, Amisulpride, Clozapine, Melissa officinalis (leaf extract)