Donormil

Donormil is a trade name for a drug whose main active ingredient is doxylamine. Doxylamine belongs to a class of drugs called histamine H1 receptor antagonists. It is often used as a sleep aid due to its mode of action, which involves suppressing the central nervous system and blocking histamine receptors.

Doxylamine is commonly available in tablet form. It is important to use Donormil as directed by your doctor or the package insert to minimize the risk of side effects and achieve optimal sleep.

Indications Donormila

1. Insomnia: Donormil is used to treat short-term and periodic conditions of insomnia, when falling asleep is difficult or sleep is not deep enough.
2. Reduce nighttime awakenings: The drug may help reduce the number of nighttime awakenings and improve overall sleep duration.
3. Improving the quality of sleep: Donormil can help improve the quality of sleep, making it deeper and more refreshing.
4. Symptomatic treatment of the runny nose: In some cases, doxylamine is used for the symptomatic treatment of the runny nose, especially in combination with other medications to relieve cold symptoms.

Release form

Conventional tablets: Traditional tablets that are taken orally with water.

Pharmacodynamics

Doxylamine blocks the effect of histamine on peripheral and central H1 receptors in the body.

Histamine is a neurotransmitter that plays a key role in regulating wakefulness and sleep. Its action on H1 receptors in the central nervous system is associated with the regulation of wakefulness. Blocking histamine H1 receptors with doxylamine leads to a sedative and hypnotic effect, promoting rapid onset of sleep and improving sleep quality.

In addition, doxylamine also has anticholinergic properties, which may lead to additional sedation and a decrease in hyperactivity in the central nervous system.

In general, the pharmacodynamics of donormyl (doxylamine) is associated with its ability to block histamine H1 receptors and have anticholinergic properties, which leads to sedative, hypnotic and antihistamine effects.

Pharmacokinetics

1. Absorption: Doxylamine is usually rapidly and completely absorbed from the gastrointestinal tract after oral administration.
2. Distribution: Doxylamine has a large volume of distribution, indicating its distribution in many tissues of the body. It can cross the placental barrier and is found in breast milk.
3. Plasma protein binding: Approximately 50-60% of doxylamine is bound to plasma proteins.
4. Metabolism: Doxylamine is metabolized in the liver to form several metabolites, including doxylamine N-oxide and hydroxydoxyamine. The main route of metabolism is N-demethylation, which is carried out by the cytochrome P450 enzyme, mainly CYP2D6 and CYP2C9.
5. Elimination: Doxylamine is excreted from the body primarily through the kidneys in the form of metabolites. Its half-life is approximately 10-12 hours.
6. Pharmacokinetics in different populations: In elderly patients or patients with impaired renal function, the pharmacokinetic parameters of doxylamine may be altered.

Dosing and administration

Method of application:

• Lozenges and regular tablets: Take before bed. The tablet should be swallowed whole with water, without chewing, to maintain controlled release of the active substance. Lozenges should be dissolved slowly in the mouth without chewing.

Dosage for adults:

• The usual dose is 15 mg of doxylamine (usually equivalent to one tablet) 30 minutes before bedtime. In some cases, especially with severe difficulty falling asleep, the dose may be increased to 30 mg (two tablets).

Dosage for elderly patients:

• Older adults or those with other medical conditions may require a dose reduction. It is recommended to start with half the usual dose (about 7.5 mg) to assess the response to the drug.

Special instructions:

• Duration of treatment: Donormil is intended for short-term use, usually no more than 7-10 days. If symptoms of insomnia persist for more than two weeks, you should see a doctor for further evaluation.
• Caution: Doxylamine may cause drowsiness the next day, so after taking the drug you should avoid driving or operating machinery. Alcohol may increase the sedative effects of doxylamine.

Use Donormila during pregnancy

The use of doxylamine (Donormil) during pregnancy is widely discussed in the medical community. Key findings from the research:

1. Safety in Pregnancy: Doxylamine is the first drug recommended for the treatment of morning sickness and vomiting in pregnancy by Canadian guidelines and is often prescribed to pregnant women. Limited data suggest that doxylamine-pyridoxine may be more effective than pyridoxine monotherapy, but there is stronger support for the safety of pyridoxine monotherapy compared with doxylamine-pyridoxine combination during pregnancy. Some conflicting data link the use of doxylamine-pyridoxine to pyloric stenosis and childhood malignancies (Persaud et al., 2014).
2. Efficacy and Safety: A study in a large number of pregnant women found that doxylamine is safe for use during pregnancy and is not associated with an increased risk of birth defects, preterm birth, or low birth weight (Chin et al., 2013).

These data suggest that doxylamine can be used during pregnancy, especially for the treatment of morning sickness and vomiting, with caution and under the guidance of a physician. Always consult your doctor before using any medications during pregnancy.

Contraindications

1. Allergic reaction: People with a known allergy to doxylamine or any other ingredient of the drug should avoid its use.
2. Urine problems: Doxylamine may increase symptoms with previous difficulty urinating. People with prostatic hyperplasia or other urinary problems should avoid using it without consulting a doctor.
3. Liver problems: Patients with severe liver dysfunction or liver failure should use doxylamine with caution.
4. Pregnancy and breast-feeding: Doxylamine can cross the placenta and be excreted in breast milk, so its use is not recommended during pregnancy or breast-feeding without medical advice.
5. Heart and blood pressure problems: Patients with heart failure, arrhythmia, or hypertension should avoid doxylamine or take it under strict medical supervision.
6. Glaucoma: Doxylamine may increase the symptoms of glaucoma (increased intraocular pressure), so its use is not recommended in people with glaucoma without consulting a doctor.

Side effects Donormila

1. Drowsiness: One of the most common side effects of taking Donormil, which may be a desired effect in the treatment of insomnia, but can also cause drowsiness the next day.
2. Dry mouth: This is common with many drugs that affect the nervous system.
3. Dizziness or headache: Some users may experience dizziness or headaches after taking doxylamine.
4. Fatigue or general feeling of being unwell: Doxylamine may make you feel tired or weak.
5. Gastrointestinal problems: Some people may experience nausea, constipation, or other gastrointestinal problems.
6. Increased irritability or nervousness: In rare cases, doxylamine may cause changes in mood or behavior.
7. Difficulty urinating: Like many other antihistamines, doxylamine may cause difficulty urinating, especially in older adults or people with prostate problems.
8. Allergic reactions: Although rare, skin rashes, itching, or other signs of an allergic reaction are possible.

Overdose

1. Extreme drowsiness or prolonged periods of restless sleep.
2. Dizziness and loss of coordination.
3. Difficulty breathing or slow heart rate.
4. Dry mouth.
5. Pupil dilation.
6. Convulsions.
7. Loss of consciousness.

Interactions with other drugs

1. Central depressants: Doxylamine has a sedative effect, so its concomitant use with other central depressants such as alcohol, benzodiazepines or narcotic analgesics may enhance the depressant effects on the central nervous system and lead to an increased risk of respiratory depression.
2. Anticholinergic drugs: Concomitant use of doxylamine with other anticholinergic drugs, such as antihistamines, some antidepressants, or antispasmodics, may increase the anticholinergic effects and lead to increased side effects such as dry mouth, constipation, and urinary retention.
3. Monoamine oxidase inhibitors (MAOIs): Concomitant use of doxylamine with MAOIs may increase sedation and increase the risk of serious side effects such as hypertensive crisis.
4. Drugs that enhance the antidopaminergic effect: Concomitant use with antidopaminergic drugs, such as antipsychotics or antiparkinsonian drugs, may enhance their effect and lead to increased side effects.
5. Alcohol: Drinking alcohol with doxylamine may increase sedation and increase the risk of unwanted side effects.