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 usually available in tablet form. It is important to use Donormil as directed by your doctor or as per 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 intermittent conditions of insomnia, when falling asleep is difficult or sleep is not deep enough.
2. Reduced frequency of night awakenings: The drug may help reduce the number of night awakenings and improve overall sleep duration.
3. Improved sleep quality: Donormil can help improve the quality of sleep, making it deeper and more refreshing.
4. Symptomatic treatment of the common cold: In some cases, doxylamine is used for the symptomatic treatment of the common cold, especially in combination with other medications to relieve cold symptoms.

Release form

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

Pharmacodynamics

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

Histamine is a neurotransmitter that plays a key role in the regulation of 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 produces a sedative and hypnotic effect, promoting rapid onset of sleep and improving its quality.

In addition, doxylamine also has anticholinergic properties, which may lead to additional sedative effects and reduced hyperactivity in the central nervous system.

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

Pharmacokinetics

1. Absorption: Doxylamine is generally rapidly and completely absorbed from the gastrointestinal tract after oral administration.
2. Distribution: Doxylamine has a large volume of distribution, indicating that it is distributed into 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 hydroxydoxylamine. The major metabolic pathway is N-demethylation, which is mediated by cytochrome P450 enzymes, primarily CYP2D6 and CYP2C9.
5. Elimination: Doxylamine is eliminated from the body primarily through the kidneys as 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

Directions for use:

• Oral lozenges and tablets: Take at bedtime. Swallow the tablet whole with water without chewing to maintain controlled release of the active substance. Oral lozenges should be allowed to dissolve slowly in the mouth without chewing.

Dosage for adults:

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

Dosage for elderly patients:

• Elderly people or those with other medical conditions may need a lower dose. 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 insomnia symptoms persist for more than two weeks, a doctor should be consulted for further evaluation.
• Caution: Doxylamine may cause drowsiness the next day, so you should avoid driving or operating machinery after taking the drug. Alcohol may enhance the sedative effect of doxylamine.

Use Donormila during pregnancy

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

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

These data indicate that doxylamine can be used during pregnancy, especially for the treatment of morning sickness and vomiting, provided that it is used with caution and under the guidance of a physician. Always consult a physician before using any medication during pregnancy.

Contraindications

1. Allergic reaction: People with a known allergy to doxylamine or any other ingredient in the drug should avoid using it.
2. Urinary problems: Doxylamine may worsen symptoms of previous urinary difficulty. People with prostate enlargement or other urinary problems should avoid its use without consulting a doctor.
3. Liver problems: Patients with severe liver dysfunction or liver failure should use doxylamine with caution.
4. Pregnancy and breastfeeding: Doxylamine can cross the placenta and be excreted in breast milk, so its use is not recommended during pregnancy and breastfeeding without consulting a doctor.
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 symptoms of glaucoma (increased pressure in the eye), 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 treating insomnia, but can also cause drowsiness the next day.
2. Dry mouth: This is a common occurrence with many medications 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 cause you to feel tired or weak.
5. Gastrointestinal Disturbances: 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 a prolonged period of restless sleep.
2. Dizziness and loss of coordination.
3. Difficulty breathing or slow heart rate.
4. Dry mouth.
5. Dilation of the pupils.
6. Cramps.
7. Loss of consciousness.

Interactions with other drugs

1. Central depressant drugs: Doxylamine has a sedative effect, so its combined use with other central depressant drugs such as alcohol, benzodiazepines or narcotic analgesics may increase the depressant effect 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, certain antidepressants, or antispasmodics, may enhance 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 neuroleptics or antiparkinsonian agents, may enhance their effect and lead to increased side effects.
5. Alcohol: Drinking alcohol with doxylamine may increase the sedative effects and increase the risk of unwanted side effects.