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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Food Allergenic Extract [EPC]
Passiflora Incarnata Flower is a botanical extract classified as a Non-Standardized Plant Allergenic Extract, often utilized for its sedative and anxiolytic properties through GABAergic modulation.
Name
Passiflora Incarnata Flower
Raw Name
PASSIFLORA INCARNATA FLOWER
Category
Non-Standardized Food Allergenic Extract [EPC]
Drug Count
11
Variant Count
12
Last Verified
February 17, 2026
About Passiflora Incarnata Flower
Passiflora Incarnata Flower is a botanical extract classified as a Non-Standardized Plant Allergenic Extract, often utilized for its sedative and anxiolytic properties through GABAergic modulation.
Detailed information about Passiflora Incarnata Flower
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Passiflora Incarnata Flower.
Passiflora Incarnata Flower, commonly known as Maypop or Purple Passionflower, is a perennial climbing vine native to the southeastern United States. In clinical pharmacology, Passiflora Incarnata Flower belongs to a class of drugs called Non-Standardized Plant Allergenic Extracts [EPC], though it is most widely recognized in clinical literature for its therapeutic application as a mild sedative and anxiolytic (anxiety-reducing) agent. While the FDA classifies certain preparations of this ingredient under allergenic extracts for diagnostic or desensitization purposes, the botanical itself has a long history of use in traditional and integrative medicine.
According to the FDA's Established Pharmacologic Class (EPC) system, this substance is also associated with categories such as Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], and interestingly, it is sometimes indexed alongside Copper-containing Intrauterine Device [EPC] in specific regulatory databases, though its primary clinical relevance remains in the realm of neuropsychiatric support.
Historically, Passiflora was used by Native Americans for its soothing properties. In modern clinical practice, healthcare providers may discuss its use as a complementary therapy for Generalized Anxiety Disorder (GAD) and insomnia. The FDA has not approved Passiflora Incarnata as an over-the-counter (OTC) sedative or sleep aid in the same way it has approved diphenhydramine; however, it remains a common component in many dietary supplements regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
The pharmacological activity of Passiflora Incarnata Flower is attributed to a complex synergy of phytochemicals, including flavonoids (such as chrysin, apigenin, and luteolin), alkaloids (harman, harmine, and harmaline), and various glycosides. At the molecular level, the primary mechanism of action involves the modulation of the gamma-aminobutyric acid (GABA) system. GABA is the primary inhibitory neurotransmitter in the central nervous system (CNS), responsible for reducing neuronal excitability.
Research suggests that extracts of Passiflora Incarnata bind to the GABA-A and GABA-B receptors. Unlike benzodiazepines, which act as positive allosteric modulators at specific subunits, Passiflora appears to increase the levels of GABA in the synaptic cleft by inhibiting GABA reuptake or promoting its release from presynaptic neurons. This increase in GABAergic tone leads to a hyperpolarization of the postsynaptic membrane, resulting in an anxiolytic and sedative effect. Furthermore, certain flavonoids like chrysin have demonstrated high-affinity binding to the benzodiazepine site of the GABA-A receptor complex in animal models, providing a molecular basis for its calming effects without the significant motor impairment often seen with synthetic sedatives.
The pharmacokinetics of Passiflora Incarnata are complex due to the multi-constituent nature of the extract.
While primarily categorized as an allergenic extract in specific regulatory contexts, Passiflora Incarnata Flower is frequently utilized for the following conditions:
Passiflora Incarnata Flower is available in several preparations, including:
> Important: Only your healthcare provider can determine if Passiflora Incarnata Flower is right for your specific condition.
Dosage for Passiflora Incarnata Flower varies significantly depending on the concentration of the extract and the specific condition being addressed. For Generalized Anxiety Disorder (GAD), healthcare providers typically suggest a standardized extract of 400 mg to 900 mg daily, often divided into two or three doses. If using a liquid tincture (1:5 ratio), a common dose is 2 mL to 4 mL three times daily. For Insomnia, a single dose of 300 mg to 450 mg taken approximately 30 to 60 minutes before bedtime is common. If consumed as a tea, 0.5g to 2g of the dried herb steeped in 150mL of water may be used up to three times per day. Because these products are often non-standardized, it is vital to follow the specific labeling on the product or the instructions provided by a qualified healthcare professional.
Passiflora Incarnata Flower is not routinely recommended for use in children under the age of 12 due to a lack of robust safety data and clinical trials in this population. Some traditional practices use lower doses for children (e.g., 100 mg to 200 mg), but this should never be initiated without the direct supervision of a pediatrician. The risk of paradoxical excitation or excessive sedation is higher in pediatric patients. If a healthcare provider determines the benefit outweighs the risk, they will calculate a weight-based or age-based dose specifically for the child.
Data regarding the use of Passiflora in patients with kidney disease is limited. Since metabolites are primarily cleared through the kidneys, patients with a GFR (Glomerular Filtration Rate) below 30 mL/min should use this substance with extreme caution. A dose reduction of 50% may be considered by a healthcare provider to prevent accumulation and excessive CNS depression.
Because the liver is the primary site for the conjugation of flavonoids and alkaloids, patients with hepatic insufficiency (Child-Pugh Class B or C) should avoid high doses. Impaired metabolism can lead to increased plasma levels and a higher risk of side effects such as dizziness or confusion.
Geriatric patients are more sensitive to the CNS effects of GABAergic substances. Healthcare providers generally recommend starting at the lowest possible dose (e.g., 100 mg to 200 mg) to minimize the risk of ataxia (loss of coordination), falls, and cognitive impairment.
Passiflora Incarnata can be taken with or without food. However, taking it with a light meal may reduce the risk of gastrointestinal upset.
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up, as this increases the risk of excessive sedation.
Signs of an overdose of Passiflora Incarnata Flower include extreme drowsiness, lethargy, muscle weakness, and slowed heart rate (bradycardia). In severe cases, it may lead to CNS depression. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately. Treatment is primarily supportive, focusing on maintaining respiratory function and hydration.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
The most frequently reported side effect of Passiflora Incarnata Flower is somnolence (drowsiness). Patients often describe a feeling of heaviness or a strong urge to sleep shortly after administration. This effect is dose-dependent and typically lasts for 4 to 6 hours. Other common effects include:
> Warning: Stop taking Passiflora Incarnata Flower and call your doctor immediately if you experience any of these.
Data on the long-term use (greater than 8 weeks) of Passiflora Incarnata Flower is sparse. Potential long-term effects may include:
There are currently no FDA black box warnings for Passiflora Incarnata Flower. However, because it is often sold as a dietary supplement, the FDA does not evaluate its safety and efficacy with the same rigor as prescription medications. Patients should remain vigilant for any unusual symptoms.
Report any unusual symptoms to your healthcare provider.
Passiflora Incarnata Flower is generally considered safe for short-term use in healthy adults. However, because it acts as a central nervous system (CNS) depressant, it must be used with caution. Patients should be aware that the potency of botanical extracts can vary significantly between brands, leading to unpredictable effects. Always inform your healthcare team of all supplements you are taking, especially before undergoing any medical procedures.
No FDA black box warnings for Passiflora Incarnata Flower.
For short-term use, routine laboratory monitoring is typically not required. However, for individuals using Passiflora chronically or at high doses, healthcare providers may monitor:
Do not drive, operate heavy machinery, or engage in hazardous activities until you know how Passiflora Incarnata Flower affects you. The sedative effects can be profound and may impair your reaction time and judgment. This impairment may persist into the morning if taken as a sleep aid the night before.
Alcohol should be strictly avoided while taking Passiflora Incarnata Flower. Alcohol synergistically increases the CNS depressant effects of the plant, which can lead to dangerous levels of respiratory depression, extreme dizziness, and loss of consciousness.
While Passiflora does not typically cause a severe withdrawal syndrome, it is advisable to taper the dose gradually if it has been used daily for several weeks. Abruptly stopping may result in 'rebound' anxiety or insomnia, where symptoms return more intensely than before.
> Important: Discuss all your medical conditions with your healthcare provider before starting Passiflora Incarnata Flower.
Passiflora Incarnata Flower is not known to significantly interfere with most common laboratory tests (such as glucose or cholesterol panels). However, its use should be disclosed to a doctor if undergoing a Urine Drug Screen, as some botanical constituents can occasionally cause false-positive results in specific immunoassay tests for benzodiazepines, though this is rare.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Passiflora Incarnata Flower must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis by a healthcare provider include:
Patients who are allergic to other species of the Passionflower genus (such as Passiflora edulis) are highly likely to be cross-sensitive to Passiflora incarnata. Additionally, there is a theoretical risk of cross-reactivity in patients with latex-fruit syndrome, although clinical evidence for this specific link is limited.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Passiflora Incarnata Flower.
Passiflora Incarnata Flower is classified as Category X in the context of pregnancy by many herbal monographs, although it does not have an official FDA pregnancy letter category. Clinical data and animal studies indicate that the harmala alkaloids present in the plant can cause uterine contractions. Therefore, use during any trimester of pregnancy is considered unsafe and should be strictly avoided to prevent potential teratogenicity or pregnancy loss.
It is unknown if the active constituents of Passiflora Incarnata Flower pass into human breast milk. Due to the lack of safety data and the potential for the infant to experience excessive sedation or poor feeding, the use of Passiflora is generally not recommended for nursing mothers. Healthcare providers usually suggest safer, better-studied alternatives for anxiety or sleep during lactation.
As noted in the dosage section, Passiflora is not approved for use in infants or young children. In adolescents (ages 12-18), it may be used under strict medical supervision for short-term anxiety, but healthcare providers must monitor for paradoxical reactions, such as increased agitation or irritability, which are more common in younger populations.
Elderly patients (over 65 years of age) are at a significantly increased risk for adverse effects from Passiflora. Age-related declines in renal and hepatic clearance can lead to higher systemic exposure. The primary concern in this population is the risk of falls and fractures due to ataxia and sedation. Additionally, the risk of polypharmacy (taking multiple medications) increases the likelihood of drug-drug interactions. Geriatric use should always start at the lowest possible dose with frequent monitoring of cognitive status.
In patients with moderate to severe renal impairment, the excretion of flavonoid conjugates may be delayed. While specific GFR-based dosing tables do not exist for this botanical, a cautious approach is required. Patients on hemodialysis should avoid use unless specifically directed by their nephrologist, as the clearance of these complex molecules during dialysis is not well-characterized.
Patients with cirrhosis or other forms of chronic liver disease may have a reduced capacity to metabolize the harman alkaloids. This can lead to prolonged sedation and an increased risk of encephalopathy (brain dysfunction due to liver failure). Use is generally discouraged in patients with a Child-Pugh score of 7 or higher.
> Important: Special populations require individualized medical assessment.
Passiflora Incarnata Flower exerts its therapeutic effects primarily through the modulation of the GABAergic system. The extract contains a variety of bioactive compounds, but the flavonoids (such as chrysin) and the GABA amino acid itself (which is present in the plant) are thought to be the primary drivers of its anxiolytic activity.
| Parameter | Value |
|---|---|
| Bioavailability | Low to Moderate (Highly variable by extract type) |
| Protein Binding | ~70% to 90% (primarily for flavonoids like Chrysin) |
| Half-life | 4 to 12 hours (constituent dependent) |
| Tmax | 1.5 to 2.5 hours |
| Metabolism | Hepatic (Phase II Glucuronidation) |
| Excretion | Renal (80%), Fecal (20%) |
Passiflora Incarnata is categorized as a Non-Standardized Plant Allergenic Extract [EPC]. In a broader therapeutic context, it is considered an Anxiolytic and Sedative-Hypnotic Botanical. It shares similar properties with other GABA-modulating herbs like Valeriana officinalis and Melissa officinalis.
Medications containing this ingredient
Common questions about Passiflora Incarnata Flower
Passiflora Incarnata Flower is primarily used as a natural remedy to manage symptoms of Generalized Anxiety Disorder (GAD) and various sleep disturbances, such as insomnia. Healthcare providers may suggest it for its ability to promote relaxation and reduce nervousness without the heavy 'hangover' effect associated with some prescription sedatives. It is also sometimes explored as a supportive treatment for managing the symptoms of withdrawal from substances like nicotine or opiates. In certain regulatory settings, it is used as an allergenic extract for diagnosing or treating specific plant-based allergies. Always consult with a medical professional before using it for any clinical condition to ensure it is appropriate for your health profile.
The most common side effects reported by users of Passiflora Incarnata Flower include significant drowsiness, dizziness, and a feeling of lightheadedness. Some individuals may also experience mild gastrointestinal issues, such as nausea or stomach cramps, particularly when taking the supplement on an empty stomach. Because it affects the central nervous system, a temporary lack of coordination or 'clumsiness' (ataxia) can also occur. These effects are usually dose-dependent and subside as the body processes the extract. If you experience severe confusion or an allergic reaction, you should seek medical attention immediately.
No, you should strictly avoid consuming alcohol while taking Passiflora Incarnata Flower. Both alcohol and Passiflora act as central nervous system depressants, and combining them can lead to a dangerous synergistic effect. This combination significantly increases the risk of extreme sedation, respiratory depression, and impaired motor function, which can be life-threatening. Even small amounts of alcohol can exacerbate the dizziness and confusion associated with the herb. To ensure your safety, it is best to wait until the supplement has completely cleared your system before consuming any alcoholic beverages.
Passiflora Incarnata Flower is considered unsafe for use during pregnancy and should be avoided. The plant contains specific alkaloids, such as harmine and harmaline, which have been shown in studies to stimulate uterine contractions. These contractions can increase the risk of pregnancy complications, including premature labor or miscarriage. There is also insufficient data to determine if the extract has any teratogenic effects on the developing fetus. Pregnant women or those planning to become pregnant should discuss safer alternatives for managing anxiety or sleep with their obstetrician.
The onset of action for Passiflora Incarnata Flower typically occurs within 30 to 90 minutes after oral ingestion. When used for acute anxiety, many patients report feeling a sense of calm within the first hour. For sleep-related issues, it is generally recommended to take the supplement about an hour before your intended bedtime to allow the sedative effects to peak. The duration of the effect usually lasts between 4 and 8 hours, depending on the individual's metabolism and the dosage taken. Consistent use over several days may be required for some individuals to notice a significant improvement in chronic anxiety symptoms.
While Passiflora Incarnata Flower is not known to be physically addictive in the same way as benzodiazepines, it is generally best to avoid stopping it abruptly if you have been using it daily for an extended period. Suddenly discontinuing a GABAergic substance can sometimes lead to 'rebound' symptoms, where your anxiety or insomnia returns more severely than before. A gradual taper over a few days can help your nervous system readjust more smoothly. If you have been using high doses, consult your healthcare provider for a recommended tapering schedule. Most people using it occasionally do not experience any issues with sudden discontinuation.
If you miss a dose of Passiflora Incarnata Flower, you should take it as soon as you remember, provided it is not too close to your next scheduled dose. If it is nearly time for your next dose, it is safer to skip the missed one and continue with your regular schedule. Never take two doses at the same time to make up for a missed one, as this significantly increases the risk of excessive sedation and other side effects. Maintaining a consistent schedule helps keep stable levels of the active constituents in your system. If you frequently miss doses, consider using a pill reminder or alarm.
There is currently no clinical evidence to suggest that Passiflora Incarnata Flower causes weight gain. Unlike some prescription psychotropic medications that can alter metabolism or increase appetite, Passiflora's primary action is on the GABA system and does not typically involve the metabolic or endocrine pathways associated with weight changes. However, because it can cause sedation and lethargy, some individuals might become less physically active, which could indirectly affect weight over a long period. If you notice any unusual changes in your weight while taking this supplement, you should discuss them with your healthcare provider to rule out other causes.
Passiflora Incarnata Flower can interact with several types of medications, particularly those that also affect the central nervous system. It should be used with extreme caution alongside benzodiazepines, sleep medications, and certain antidepressants, as it can dangerously increase their sedative effects. There is also a potential for interaction with blood-thinning medications like warfarin, which may increase the risk of bleeding. Because of these risks, it is essential to provide your doctor or pharmacist with a complete list of all prescription and over-the-counter drugs you are taking. They can help you determine if Passiflora is safe to include in your regimen.
Passiflora Incarnata Flower is not a prescription drug with a brand-name/generic patent system; instead, it is widely available as a botanical extract and dietary supplement from many different manufacturers. You can find it under various labels, often simply titled 'Passionflower' or 'Passiflora.' While there is no 'generic' version in the traditional pharmaceutical sense, the quality and concentration of the active ingredients can vary significantly between different brands. It is advisable to choose products that are standardized to a specific percentage of flavonoids (like vitexin) and have been third-party tested for purity. Your healthcare provider can recommend a reputable source.