Quick Facts: Therapeutic Domain

• Provides relief of mild symptoms of nervous tension.
• Traditionally used to aid sleep and support the management of temporary difficulty falling asleep.

Uses and Benefits of Персен Ночь

Персен Ночь is a traditionally used herbal preparation indicated for the relief of mild symptoms of mental stress and to support the management of sleep disorders. The product is typically utilized by adults experiencing mild nervous tension and associated temporary difficulty falling asleep.

The preparation is intended to promote a state of calm and relaxation, helping to facilitate the onset of sleep. Its primary benefit is providing relief from mild anxiety symptoms that may interfere with daily rest and sleep quality. Due to the gradual onset of effect associated with its components, it is not suitable for acute interventional treatment. To achieve the optimal management of symptoms, continued use over a recommended period is often necessary. If symptoms persist or worsen after several weeks of continuous use, consultation with a healthcare professional is necessary.

Regulatory References

1. EMA traditional use monograph for Valerian root

The official regulatory eligibility profile for Персен Ночь (Persen Night) defines specific population groups who are permitted, restricted, or absolutely prohibited from using the medicine. This profile is derived from official government labeling, such as the Summary of Product Characteristics (SmPC).

Absolute Contraindication

The medicine is strictly contraindicated in patients with a known hypersensitivity (allergy) to any of its active herbal components (Valerian root, Lemon balm leaf, Peppermint leaf extracts) or to any of the product's excipients.

Populations Not Recommended for Use

Use is not recommended for specific sensitive groups due to the regulatory classification that cites insufficient data on safety and efficacy:

• Children and Adolescents: Patients under the age of 18 years.
• Physiological States: Women who are pregnant or lactating (breastfeeding).

Conditional Use and Caution

The product is generally permitted for use by Adults and the Older Adults (Elderly). However, special caution is required, and consultation with a healthcare professional is mandatory for:

• Patients with underlying medical conditions, such as liver problems or epilepsy.
• Individuals with known intolerance to certain sugars (due to specific excipient content).

Users must also avoid excessive consumption of alcohol during treatment and must not drive or operate machinery if affected by drowsiness.

Interactions with other medicines and products

Interaction Scope

Interaction Classifications (High-Level)

Official Interaction Statements:

• Co-medication with hypnotics is not recommended due to the potential for additive effects on Central Nervous System depression.
• Co-medication with other sedatives is not recommended as additive effects cannot be excluded.
• The effects of the medicine may be potentiated by alcohol; excessive concomitant consumption of alcohol must be avoided.
• Clinically relevant interactions with drugs metabolized by the CYP2D6, CYP3A4/5, CYP1A2, or CYP2E1 pathways have not been observed.

The official interaction profile is structured by a core pharmacodynamic risk, specifically the potential for additive CNS depressive effects when co-administered with other sedating agents or alcohol. This is balanced by regulatory statements documenting the absence of known clinically relevant pharmacokinetic interactions via the common CYP P450 enzyme pathways.

The mechanism of action for the combined extract focuses on modulation of central nervous system (CNS) gamma-aminobutyric acid (GABA) signaling. Active components from Valeriana officinalis (valerenic acids) function as positive allosteric modulators of GABA A receptors, particularly those containing beta 2 or beta 3 subunits. This interaction enhances the chloride ion influx mediated by the inhibitory neurotransmitter GABA, resulting in neuronal hyperpolarization and a decrease in CNS excitability. Valerian derivatives may also inhibit the enzyme GABA transaminase (GABA-T), leading to elevated synaptic GABA concentrations. Components from Humulus lupulus (hops), such as humulone, also act as GABA A receptor positive allosteric modulators. Melissa officinalis (lemon balm) constituents, including rosmarinic acid, further contribute by inhibiting GABA-T and potentially exhibiting direct agonist activity at GABA A receptors. The cumulative effect of these interactions is a system-level increase in inhibitory neurotransmission, which modulates the activity of arousal-promoting brain nuclei and promotes reduced general central nervous system activity.

How to Use Персен Ночь

The administration of this herbal sedative is structured around official regulatory principles, which define the high-level conditions for its use. These guidelines are not instructions for individuals but describe the standardized protocol for administration.

Official Administration Protocol

The product is an oral preparation designated for use in adults and adolescents over 12 years of age. Usage in children below this age is not recommended due to a lack of adequate data. The dosage unit (capsule or tablet) should be swallowed whole with water.

Dosing and Timeframe

The protocol defines distinct dosing patterns for its two primary contexts of use:

Daily administration is mandatory; the medicine is not suitable for acute interventional treatment due to the gradual onset of effect associated with its components. To achieve the required procedural effect, continued daily use over a period of 2 to 4 weeks is recommended. The maximum daily intake is generally limited to four single doses (or their equivalent) across the 24-hour period. If symptoms persist or worsen after the specified duration of use, further consultation is required.

Research evidence / Overview of studies for Персен Ночь

Evidence for Use in Relieving Mild Nervous Tension and Mental Stress

The use of Персен Ночь (Persen Night) has been studied in research exploring mild nervous tension and mental stress. The research base includes systematic reviews and Randomized Controlled Trials (RCTs) that has been studied in trials featuring the main component, Valerian root, often combined with Lemon Balm. Research used assessment scales to monitor patient-reported experiences with symptoms, measuring changes in nervousness and restlessness. These studies typically involved adults experiencing temporary, non-clinical stress.

Studies exploring short-term symptom changes reported how symptoms evolved in the observed populations. Findings describe patterns observed in the studies related to measurements of subjective calmness and self-reported agitation. However, the reported outcomes were based on follow-up durations that were limited, typically lasting only a few weeks. Evidence level varies across studies due to significant differences in the specific plant extracts and doses tested in each trial.

Evidence for Use as an Aid in Managing Temporary Difficulty Falling Asleep

The research has explored studies involving meta-analyses and RCTs of the principal ingredient, Valerian, in research examining temporary difficulty falling asleep. Researchers monitored several key sleep outcomes. These included patient-reported outcomes describing perceived discomfort related to sleep, such as self-assessed subjective sleep quality, the self-recorded time it took to fall asleep (Sleep Onset Latency), and the frequency of nocturnal awakenings.

Data are still emerging, and evidence is limited due to high methodological heterogeneity across trials, including major variation in the specific Valerian extracts used. Research provides insight into short-term changes, but long-term effects are not fully established, and certainty remains low regarding the impact on objective sleep architecture. Comparative evidence against other types of sleep aids is also often lacking.

Research Gaps and Areas of Uncertainty

Research highlights what is known—and what is still uncertain—about this combination. A significant limitation is the heterogeneity of the evidence, meaning the results are hard to compare because researchers used widely varying doses and different extraction methods for the same plant. Data for the specific triple-combination formulation of Valerian, Lemon Balm, and Peppermint (as found in Персен Ночь) are still emerging, with limited information available from large-scale, high-quality, double-blind trials, leaving the precise contribution of each component uncertain.

Key Studies & References

1. European Union herbal monograph on Valeriana officinalis L., radix (Valerian root)
2. Valerian for Sleep: A Systematic Review and Meta-Analysis

Common questions about Combination Pain Reliever (FAQ)

Q: Can I take this medication for migraines?

Official labeling for this combination product indicates it is used for the temporary relief of minor aches and pains, which includes headaches. Regulatory documents for specific formulations may indicate its use for migraine headaches, among other types of pain. This information is based on the Uses section of regulatory sources.

Q: Is it safe to take this product long-term or for chronic pain?

Regulatory directions generally advise that this product should not be used for more than 10 days for pain unless directed by a healthcare provider. Warnings regarding Medication Overuse Headaches are included in labeling, noting that using analgesic products for 10 or more days per month has been associated with headaches worsening or increasing in frequency.

Q: Does this product make you sleepy, or is it safe to drive after taking it?

The official warnings for this combination product, which contains caffeine, commonly list side effects such as nervousness, irritability, and sleeplessness. While drowsiness is not typically listed as a primary warning, if you experience dizziness or any altered mental status after taking the medicine, regulatory information indicates that caution should be exercised before operating machinery or driving.

Q: Can children 2 years old use this product?

This product is labeled for use in adults and children 12 years of age and over. For children under 12, a healthcare provider should be consulted before administration. Official warnings also include the risk of Reye's Syndrome for children and teenagers recovering from flu-like symptoms or chicken pox.

Q: Can I take this if I am pregnant or breastfeeding?

Official product information states that if you are pregnant or breastfeeding, it is recommended to consult a healthcare professional before use. Official warnings emphasize that aspirin should not be used during the last 3 months of pregnancy unless specifically directed by a healthcare provider, due to potential risks to the unborn child.

How to Store and Dispose of Персен Ночь

Official Storage Requirements

This medicine must be stored at a temperature below 25 C and protected from light and moisture by keeping it in a dry place. It is mandatory to store the product in its original container throughout its shelf life, which is two years, and do not use the medicine after the expiry date shown on the package. Consistent with regulatory guidelines, the product must be kept out of the sight and reach of children.

Disposal Instructions

Any unused or expired Персен Ночь must be managed as pharmaceutical waste. Official instructions state that the medicine must not be disposed of via wastewater or household waste. Disposal should be conducted according to local regulations. You should consult a pharmacist for guidance on the proper method for discarding unused medication.