GNH USA

Europe — EMA

Herbal Sleep

Herbal Sleep is an OTC oral supplement with valerian root and passion flower extracts, used to support occasional insomnia and improve sleep quality.

Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra

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What is Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra?

Herbal Sleep is an over‑the‑counter oral herbal supplement that combines a standardized dry extract of Valerian root (5‑6:1) and Passion flower (3‑7:1) dissolved in a 70 % ethanol (V/V) solution. Produced for the EU market, it is marketed as a sleep aid intended for occasional use to support normal sleep patterns.

What is Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra used for?

Herbal Sleep is positioned as a non‑prescription option for individuals seeking natural support for sleep. It may be considered in the following situations:

- Occasional difficulty falling asleep (insomnia) without underlying medical conditions. - Mild sleep disturbances associated with stress or an irregular schedule. - As part of a bedtime routine that includes relaxation techniques. - Situations where a patient prefers a botanical supplement over synthetic hypnotics. - Short‑term use during travel across time zones (jet lag).

What are the side effects of Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra?

Side effects reported with Herbal Sleep are generally mild, but users should be aware of both common and less frequent reactions.

Common: - Drowsiness or a “hangover” feeling the next morning. - Headache. - Dry mouth. - Gastrointestinal discomfort such as mild nausea. - Dizziness, especially when standing quickly.

Serious: - Allergic reactions including rash, itching, or swelling. - Severe dizziness or fainting. - Persistent vomiting. - Worsening of depression or mood changes. - Unusual heart palpitations.

What precautions apply to Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra?

Before using Herbal Sleep, consider the following precautions to ensure safe use:

- Do not operate machinery or drive until you know how the product affects you. - Avoid use if you are pregnant, nursing, or planning pregnancy without consulting a healthcare professional. - Individuals with liver disease, epilepsy, or severe psychiatric conditions should seek medical advice first. - Keep out of reach of children; accidental ingestion may cause excessive sedation. - Discontinue use and seek medical attention if an allergic reaction occurs. - Do not combine with alcohol or other central nervous system depressants.

What does Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra interact with?

Herbal Sleep may interact with certain medications or substances. Review the following guidance:

Avoid: - Alcohol, benzodiazepines, barbiturates, or other sedative‑hypnotic drugs. - Antidepressants, especially SSRIs and MAO inhibitors, due to potential additive CNS effects. - Anticoagulant or antiplatelet agents, as valerian may affect platelet aggregation.

Use with caution: - Over‑the‑counter antihistamines that cause drowsiness. - Herbal supplements such as kava, chamomile, or melatonin. - Medications metabolized by CYP450 enzymes, as valerian may influence enzyme activity. - Any drug that impairs alertness or coordination.

Frequently asked questions

What is the primary purpose of Herbal Sleep?+
Herbal Sleep is intended to provide a natural, over‑the‑counter option to help individuals who experience occasional difficulty falling asleep or staying asleep.
Which botanical ingredients are included in Herbal Sleep?+
The product contains a standardized dry extract of Valerian root (5‑6:1) and a dry extract of Passion flower (3‑7:1) dissolved in a 70 % ethanol solution.
How should Herbal Sleep be taken for best results?+
It is generally recommended to take Herbal Sleep about 30 minutes before bedtime with a small amount of water, following the dosage instructions on the label.
Can Herbal Sleep be used by children?+
Herbal Sleep is not recommended for children unless a qualified healthcare professional advises otherwise.
Is Herbal Sleep safe to use during pregnancy or breastfeeding?+
Pregnant or nursing individuals should consult a healthcare provider before using Herbal Sleep, as safety has not been established for these populations.
What are the most common side effects of Herbal Sleep?+
Common side effects may include mild drowsiness the next morning, headache, dry mouth, mild nausea, and occasional dizziness.
Are there any serious adverse reactions associated with Herbal Sleep?+
Serious reactions are rare but can include allergic skin reactions, severe dizziness, persistent vomiting, worsening mood symptoms, or unusual heart palpitations.
Should I avoid alcohol while taking Herbal Sleep?+
Yes, alcohol can increase the sedative effect of Herbal Sleep and should be avoided to reduce the risk of excessive drowsiness.
Can Herbal Sleep interact with prescription medications?+
Herbal Sleep may interact with sedatives, antidepressants, anticoagulants, and drugs metabolized by CYP450 enzymes; consult a pharmacist or physician if you take such medications.
How long can I safely use Herbal Sleep?+
Herbal Sleep is intended for short‑term use; if sleep difficulties persist for more than a few weeks, seek medical evaluation.
Is Herbal Sleep classified as a controlled substance?+
No, Herbal Sleep is an over‑the‑counter herbal supplement and is not listed as a controlled substance.
Where is Herbal Sleep manufactured?+
The product is manufactured for the European Union market and complies with EU regulations for dietary supplements.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Valerian Root Dry Extract (5-6:1), Ethanol 70 %(V/V), Dry Extract From Passion Flower (3-7:1): Extra
Route
Oral Use
Manufacturer
The Herbal Research Company Limited
Origin
EU

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