Zolsana

Zolsana is a substance similar to benzodiazepine. Contains the component zolpidem.

Indications Zolsana

It is used for short-term relief of insomnia.

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Release form

The therapeutic element is released in tablet form, 10 pieces inside a cell plate. The pack contains 3, 6, 9 or 12 such plates.

Pharmacodynamics

Zolpidem is a benzodiazepine-like hypnotic drug. It belongs to the imidazopyridine class of drugs, which induce sedative and hypnotic effects (by exerting a specific agonist effect on central benzodiazepine endings that are part of the macromolecular complex of GABA-ω endings (BZ1 and BZ2), which is located in neuronal membranes and acts by opening chloride ion channels).

The high selectivity of zolpidem for the first subtype of ω1-endings (BZ1) contributes to the development of a significant sedative effect at doses that are lower than those causing muscle relaxant, anticonvulsant and anxiolytic activity.

Pharmacokinetics

Zolpidem is completely and rapidly absorbed, resulting in rapid onset of hypnotic effects.

After oral administration, the bioavailability level is 70%. With presystemic exchange processes, the absolute bioavailability index is about 35%. Plasma Cmax values are recorded after 0.5-2 hours after using the drug. Therapeutic plasma indices are determined in the range of 80-200 ng/ml. The distribution volume level is 0.54 l/kg; in elderly people, this index decreases to 0.34 l/kg. Intraplasmic synthesis with protein is approximately 92% of the active element.

Intrahepatic metabolic processes lead to the formation of several metabolic products that have no medicinal activity. A small portion of zolpidem penetrates into breast milk.

The mean half-life is 2.4 hours with a duration of action of 6 hours. Excretion in the form of inactive metabolic products occurs in urine (56%) and faeces (37%).

Dosing and administration

The therapeutic cycle should be as short as possible – no longer than 14 days. The maximum permissible duration of therapy is 1 month, which also includes a period during which the drug is gradually discontinued. In exceptional situations, the period of therapy may be extended.

The duration of the treatment cycle is determined by the doctor, taking into account the course of the disease and the patient's condition. The medication should be taken orally, in the evening, before bedtime. 10 mg of the substance should be used per day. At the same time, elderly people, patients with sensitivity to zolpidem and people with moderate or mild renal failure should take 5 mg of the drug once a day. If there is no effect, and the drug is tolerated without complications, the dosage is increased to 10 mg. The maximum daily dose is 10 mg.

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Use Zolsana during pregnancy

There is too little information about the safety of zolpidem in lactating or pregnant women. Therefore, it is not prescribed during these periods (especially in the first trimester). If Zolsana is prescribed to a woman of reproductive age, she should be warned about the need to stop the drug and inform her doctor if she plans to become pregnant.

If the medication is used late in pregnancy or during labor, the newborn may develop hypothermia, low blood pressure, and moderate respiratory depression (due to the drug's medicinal effects).

Contraindications

Among the contraindications:

• severe intolerance associated with the components of the drug;
• severe liver failure;
• sleep apnea syndrome;
• severe respiratory failure;
• myasthenia;
• acute alcohol poisoning or chronic alcoholism.

Side effects Zolsana

Often, the use of drugs leads to headaches, feelings of confusion or drowsiness, decreased emotionality, as well as dizziness, gastrointestinal disorders (nausea, diarrhea or vomiting), vertigo, rashes, diplopia or amnesia, and decreased attention.

Anterograde amnesia may occur, especially if large doses of the drug are used, which may be accompanied by inappropriate behavior. Depression may develop or symptoms of existing depression may be exacerbated. In elderly people, paradoxical mental symptoms often appear: a feeling of excitement, aggression, anxiety or irritability, behavioral disorders, nightmares, hallucinations, anger and psychosis, as well as obsessive ideas.

Occasionally, muscle weakness, fatigue, or ataxia may occur.

A weakening of libido is occasionally observed. These symptoms develop at the initial stage of therapy and disappear after repeated use of the drug.

Even the use of therapeutic doses of the drug can cause physical dependence: discontinuing the drug can provoke withdrawal syndrome.

Psychological dependence may also develop along with drug abuse.

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Overdose

Signs of poisoning: dizziness, nausea, ataxia, visual disturbances, bradycardia and respiratory distress. In addition, a feeling of drowsiness, unstoppable vomiting, convulsions, loss of consciousness, inappropriate behavior, and also a treatable coma.

Gastric lavage, the use of activated carbon, symptomatic and supportive procedures are prescribed (it is necessary to constantly monitor the work of the cardiovascular system and breathing). At the same time, it is necessary to refuse the use of any sedatives, even if the patient is agitated.

Zolpidem cannot be excreted by dialysis.

Interactions with other drugs

Combination with hypnotics, anticonvulsants, neuroleptics, antidepressants, as well as muscle relaxants, anesthetics, antihistamine sedatives and opioid analgesics can potentiate the hypnotic effect. Combination with opioid analgesics can potentiate the feeling of euphoria, which increases psychological dependence.

Substances with a strong inducing effect on the enzymes of hemoprotein 450 potentiate the metabolic breakdown of zolpidem, due to which its plasma indices fall (by almost 60%), and the medicinal effectiveness is weakened.

Use together with inhibitors of CYP 3A4 components (except itraconazole) may provoke an increase in plasma values of zolpidem and potentiation of the drug effect.

During the period of using Zolsana, you should refrain from drinking alcohol, because it potentiates the sedative activity of zolpidem.

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Storage conditions

Zolsana should be stored in a place closed to children. Temperature values - no higher than 25°C.

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Shelf life

Zolsana can be used for a period of 5 years from the date of manufacture of the drug.

Application for children

Zolsana is not prescribed to children under 18 years of age.

A newborn baby, if its mother used the drug in the last stage of pregnancy, may experience withdrawal syndrome due to the development of physical dependence.

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Analogues

The drug's analogues are Hypnogen, Zolpidem, Nitrest with Zonadin, and also Snovidel and Ivadal with Sanval.