Dormiplant

Dormiplant is a combined herbal preparation designed to improve sleep and calm the nervous system. It contains two main active components: dry extract of rhizomes with roots of valerian and dry extract of leaves of lemon balm. Both of these components are known for their calming and sedative properties.

Main components and their actions:

1. Dry extract of rhizomes with roots of valerian:

   • Valerian (Valeriana officinalis) is one of the most well-known remedies for insomnia and nervous excitement. It has a calming effect on the central nervous system, helps reduce the time it takes to fall asleep and improves the quality of sleep.

2. Dry extract of lemon balm leaves:

   • Melissa (Melissa officinalis) – used to reduce stress, anxiety, and nervous tension. Melissa also has a mild antispasmodic effect, which can promote overall relaxation and improve sleep.

Indications Dormiplanta

1. Insomnia: Difficulty falling asleep, waking up frequently, and restless sleep.
2. Increased nervous excitability: Conditions accompanied by anxiety, irritability and stress.
3. Anxiety and worry states: Help with nervous disorders and stressful situations.

Release form

Dormiplant is available in the form of film-coated tablets.

Pharmacodynamics

1. Dry extract of rhizomes with roots of valerian

Mechanism of action: Valerian contains several active components, including valerenic acids and valeriopolysaccharides, which have an anxiolytic (anti-anxiety) and sedative (sleep-inducing) effect. They affect the central nervous system, increasing the activity of inhibitory neurotransmitters such as gamma-aminobutyric acid (GABA), which helps reduce anxiety and improve sleep.

Effects:

• Improving sleep quality
• Reducing anxiety and nervous tension
• Relieving symptoms of stress and nervousness

2. Dry extract of lemon balm leaves

Mechanism of action: Melissa, or lemon balm, also contains a number of active components, including essential oils, terpenes and flavonoids. It has anxiolytic, sedative and antispasmodic effects. Melissa essential oils, including citral and citronellal, have a beneficial effect on the central nervous system, reducing anxiety and promoting muscle relaxation.

Effects:

• Improving mood
• Reduced anxiety and irritability
• Improving sleep quality

Synergistic action

The combination of valerian and lemon balm extracts in Dormiplant allows for their sedative and anxiolytic effects to be enhanced through synergy. This means that the effects of each component are enhanced when used together, making the drug more effective in improving sleep and alleviating nervous tension.

Pharmacokinetics

1. Dry extract of rhizomes with roots of valerian:

   • Absorption: Valerian extract is usually taken orally and absorbed through the gastrointestinal tract. It may be poorly absorbed or not absorbed at all.
   • Distribution: Valerian substances absorbed into the body can be evenly distributed throughout the tissues.
   • Metabolism and excretion: Valerian is metabolized in the liver. The main metabolites are glucuronides and sulfates. They are excreted from the body primarily through the kidneys.

2. Dry extract of lemon balm leaves:

   • Absorption: Melissa extract is also taken orally. Its components may be better absorbed than valerian.
   • Distribution: After absorption, lemon balm components can be evenly distributed throughout the body tissues.
   • Metabolism and excretion: Melissa is also metabolized in the liver, and the metabolites are excreted from the body through the kidneys.

Dosing and administration

Directions for use:

• The tablets are intended for oral administration.
• The tablet should be swallowed whole with a sufficient amount of water, without chewing.

Dosage:

• Adults and children over 12 years of age are recommended to take 2 tablets 2 times a day.
• If necessary, to improve sleep, you can take 2 tablets half an hour before bedtime.

Use Dormiplanta during pregnancy

The use of herbal medicines, including Dormiplant, during pregnancy requires caution. Scientific evidence of the safety of such products for pregnant women is insufficient, which raises concerns, especially regarding their teratogenic effects.

1. Lack of regulation and potential risks: Herbal products such as those containing valerian and lemon balm are often perceived as safe because they are natural, but they may contain substances that can be harmful during pregnancy. There are no strong regulations controlling their sale, and they may cause teratogenic or abortifacient effects, making them risky for pregnant women (Bernstein et al., 2020).
2. Limited data on safety and effectiveness: Research generally shows that some herbs, such as ginger, have been studied and found to be relatively safe in controlled doses, but the effectiveness and safety of many other herbal remedies, including those contained in Dormiplant, are not well supported by scientific research. Pregnant women often use these remedies without consulting a doctor, which can lead to unexpected complications (Sarecka-Hujar & Szulc-Musioł, 2022).
3. Use of herbs during pregnancy: A significant number of pregnant women report using herbal remedies to treat common pregnancy-related problems, often without consulting a health care professional. Self-medication poses risks due to the unknown effects of many herbs on pregnancy and fetal development (Holst et al., 2009).

Although herbal medicines such as Dormiplant are often used during pregnancy, they should be used with caution and under medical supervision. Pregnant women should consult with their doctor to discuss the use of any herbal remedies to avoid potential risks to their health and the health of their unborn child.

Contraindications

1. Allergy to components of the drug: People with known hypersensitivity or allergy to any of the components of Dormiplant (valerian, lemon balm) should avoid using it.
2. Pregnancy and breastfeeding: The safety of using Dormiplant during pregnancy and breastfeeding has not been established, so its use in these cases should be agreed with a doctor.
3. Paediatric age: The use of Dormiplant in children under 12 years of age is generally not recommended without prior consultation with a doctor.
4. Liver problems: People with severe liver problems should use Dormiplant with caution and under medical supervision.
5. Alcohol problems: Because Dormiplant contains alcohol (usually as a preservative), it may not be suitable for people with alcohol dependence or those who are advised not to drink alcohol for medical reasons.
6. Use of other medications: Some drug interactions may occur when Dormiplant is used simultaneously with other medications, so it is important to tell your doctor about all medications you are taking.

Side effects Dormiplanta

1. Drowsiness: Especially at the beginning of treatment or when the dose is increased.
2. Dizziness: May occur in some people.
3. Stomach disorders: Including stomach discomfort, nausea, or vomiting.
4. Allergic reactions: Hives, itching, swelling or even anaphylactic shock in rare cases.

Overdose

• Severe drowsiness or general weakness
• Dizziness
• Low blood pressure (hypotension)
• Respiratory depression
• Reduced response to external stimuli
• Stomach upset (nausea, vomiting, diarrhea)
• Possible increase in side effects such as dry mouth or fatigue

Interactions with other drugs

1. Sleeping pills and sleep-inducing drugs: Taking Dormiplant in combination with other sleeping pills such as benzodiazepines or hypnotics may increase the sedative effect. This may result in excessive decrease in wakefulness and lethargy.
2. Centrally acting drugs: Additional drugs that affect the central nervous system, such as antidepressants, antipsychotics or analgesics, may enhance the sedative effect of Dormiplant.
3. Drugs affecting mental state: Using Dormiplant together with drugs such as barbiturates or antiepileptic drugs may increase or change the effects on mental state.
4. Alcohol: Drinking alcohol with Dormiplant may enhance its sedative effects and increase the risk of side effects such as dizziness, confusion, and drowsiness.
5. Drugs that increase bleeding: Valerian may have a minor effect on prothrombin levels in the blood, so using Dormiplant with anticoagulants or antiplatelet agents may increase the risk of bleeding.