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Reladorm
Last reviewed: 04.07.2025
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Indications Reladorma
It is used to treat chronic insomnia, as well as when a feeling of irritability develops or when sleep is short.
Release form
The medicinal substance is released in tablets, in the amount of 10 pieces inside a blister pack. The pack contains 1 such package.
Pharmacodynamics
The drug has sedative, anxiolytic, hypnotic, central, anticonvulsant and muscle relaxant properties.
The active components of the drug are diazepam with cyclobarbital. Diazepam is an anxiolytic tranquilizer that helps to reduce the excitability of neurons, and in addition to this, slow down spinal polysynaptic reflexes and potentiate the activity of GABA.
The drug does not have a peripheral muscle relaxant effect.
Reladorm reduces the severity of feelings of anxiety, worry, emotional tension and fear, due to which a full-fledged anxiolytic effect develops.
Cyclobarbital is a hypnotic substance with a powerful sedative effect.
Pharmacokinetics
Cyclobarbital is a barbiturate with a medium duration of action. After oral administration, it is absorbed at high speed in the digestive tract. After oral administration of 0.3 g of the substance, the Cmax indicator is noted after 20-180 minutes. Cyclobarbital has a strong connection with blood protein; it easily passes into biological fluids and tissues, and also through the placenta and into mother's milk.
The metabolic processes of cyclobarbital are mostly carried out inside the liver, with the help of microsomal enzymes. During metabolism, the component is transformed into ketocyclobarbital. The processes of hydroxylation of cyclobarbital lead to the formation of inactive hydrophilic metabolic products. Cyclobarbital has a powerful inducing effect on microsomal enzymes responsible for the metabolic processes of many drugs, including their own (autoinducer). As a result, there is a decrease and a reduction in the duration of the effect of the drugs used in the combination, which are biotransformed with the help of cytochrome P450.
The half-life is approximately 6 hours. Cyclobarbital is almost completely excreted through the kidneys in the form of metabolic products.
Diazepam is well absorbed in the gastrointestinal tract; the bioavailability index is approximately 98%. After oral administration of 20 mg of the substance, its blood Cmax values are noted after 0.9-1.3 hours and are equal to 500 ng/ml. Approximately 94-99% of the substance is synthesized with blood protein. It penetrates the BBB and placenta, as well as into breast milk. It has an intense affinity for fatty tissues.
Diazepam undergoes intrahepatic metabolism, which forms two active metabolic products - N-desmethyldiazepam and N-methyloxazepam. They are then converted to oxazepam, which is then synthesized with glucuronic acid.
The half-life of the component is approximately 0.8-2.2 days (it may increase in the elderly, newborns, and people with kidney or liver dysfunction). Diazepam is excreted mainly through the kidneys - in the form of metabolic products and unchanged (approximately 25%).
Dosing and administration
To achieve a hypnotic effect, the medication is taken 60 minutes before bedtime - 1 tablet.
To achieve a sedative effect, it is necessary to take a quarter or half a tablet 1-2 times a day.
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Use Reladorma during pregnancy
Reladorm should not be prescribed in the first trimester (except in emergency situations). Taking the medication during pregnancy may cause an increase in the fetal heart rate.
During the period of using the drug, breastfeeding should be stopped.
Contraindications
Main contraindications:
- hypercapnia;
- myasthenia;
- presence of hypersensitivity to cyclobarbital or diazepam;
- the presence of suicidal tendencies in the patient;
- porphyria;
- liver failure;
- old age.
Side effects Reladorma
The severity and number of side effects are determined by the portion size and the patient's sensitivity to the drug. Among the manifestations:
- lesions affecting the nervous system: headaches, drowsiness, disorientation or confusion are common, as well as slow reactions, ataxia and dizziness. Tremors or feelings of anger and mood deterioration occasionally occur. Dysarthria with slurred speech, memory or accommodation disorders, abnormal behavior and anterograde amnesia also occasionally develop. Emotional changes, emotional depletion, psychosis and nightmares, as well as incorrect pronunciation of words are also rarely observed;
- visual impairment: visual disturbances (diplopia or blurring);
- digestive disorders: gastrointestinal disorders, hypersalivation, dry mouth, nausea or constipation;
- problems with the functioning of the kidneys and urinary tract: urinary retention or incontinence;
- damage to connective tissues and musculoskeletal structure: the appearance of tremors;
- disorders of the cardiovascular system: slight decrease in blood pressure, bradycardia, autonomic signs, arrhythmia and heart failure (this includes cardiac arrest);
- symptoms from the respiratory system: suppression of respiratory processes (this includes respiratory failure);
- systemic disorders: feeling of general weakness (fainting occurs at times);
- lesions of the subcutaneous layer and epidermis: manifestations of skin allergies;
- disorders of the biliary tract and liver: liver dysfunction. Jaundice develops occasionally or an increase in alkaline phosphatase and transaminase levels is noted;
- signs from the mammary glands and reproductive organs: menstrual cycle or libido disorders;
- lesions affecting the lymph and blood: disorder of the morphological blood composition (development of leukopenia or agranulocytosis);
- mental disorders: the appearance of paradoxical reactions (such as a feeling of excitement (also psychomotor) or aggression, insomnia, convulsions and tremors). In the form of a paradoxical reaction, an increase in the feeling of hostility and anxiety, increased muscle tone (mainly in the elderly and children) and hallucinations are also noted. Often, such manifestations develop in the elderly and people with mental illnesses, and also after drinking alcohol;
- Others: joint pain, muscle weakness, and increased risk of fractures and falls (usually in older people).
Systematic use of drugs over many weeks can cause drug dependence or withdrawal syndrome if the drug is suddenly stopped.
Mild withdrawal symptoms include attention deficit disorder, anxiety, and headache. Dizziness, nausea, irritability, hyperhidrosis, vomiting, and sensory disturbances, muscle spasms, and colic may also occur. Heart rate may also increase, and loss of appetite may occur. Sometimes seizures or delirium may occur.
Elderly patients are extremely sensitive to negative symptoms, often experiencing movement disorders and a feeling of fatigue.
Children, the elderly and individuals with hypoprothrombinemia may be at increased risk of developing sedative side effects.
If jaundice, visual disturbances, disorders of the hematopoietic system, urinary incontinence and increased activity of liver enzymes occur, it is necessary to discontinue the use of Reladorm.
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Overdose
Symptoms of poisoning include feeling confused or sleepy, and slurred speech.
Severe intoxication can lead to the development of symptoms that threaten the patient's health and life.
To eliminate the disorders, gastric lavage is performed and activated charcoal is prescribed.
The antidote to Reladorm is considered to be the substance flumazenil.
Interactions with other drugs
The medication can potentiate the activity of sedatives, antidepressants, antipsychotics and opiates.
Use together with substances that slow down the oxidation processes of microsomes causes an increase in the half-life of Reladorm.
The drug destroys the metabolic processes of the substance phenytoin.
The drug is not compatible with griseofulvin, oral contraception, doxycycline, GCS, ethyl alcohol and anticoagulants.
Storage conditions
Reladorm should be kept in a dark place, out of reach of small children. Temperature values should not exceed 25°C.
Shelf life
Reladorm can be used within 36 months from the date of manufacture of the drug.
Application for children
The drug cannot be prescribed in pediatrics.
Analogues
Analogues of the drug are such drugs as Corvaltab, Bellamintal, Belloid with Valocordin and Corvalol with Corvaldin.
Reviews
Reladorm receives quite good reviews from patients. When following the prescribed instructions and used according to the indications, it demonstrates high efficiency.
Attention!
To simplify the perception of information, this instruction for use of the drug "Reladorm" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.