Ivadal

Ivadal is a pharmacological drug of hypnotic action, belonging to imidazopyridines. In terms of the activity of the produced amnestatic, anxiolytic, muscle relaxant, anticonvulsant and sedative effect, it has similarities with the benzodiazepine group. Thanks to the use of the drug, the duration of the period of falling asleep is reduced, the number of awakenings is reduced, sleep becomes longer and has better quality.

The medicine has the necessary qualities that allow it to be rightfully classified as an “ideal sleeping pill.” Even when taken in the minimum required dose, it ensures rapid falling asleep, and increasing the dosage does not increase the strength of its effect. This is a deterrent for those who suffer from insomnia, preventing them from independently increasing the dose of the medicine. As a result of using this sleeping pill, a person wakes up at night much less often. The medicine does not cause significant changes in the structure and stages of sleep. Its effect on the level of wakefulness during awakening, on memory, cognitive functions and reaction speed is minimal. And stopping taking it is not associated with any deterioration in the patient's condition.

Due to this, the medicine is deservedly recognized as a leader in the world market of pharmacological products aimed at normalizing healthy sleep processes. If there are any problems with sleep, then with the use of Ivadal it becomes a truly full-fledged time of night rest for the body from all the tense modern rhythm of life, problems and all sorts of stressful situations that a person can face during the day.

Indications Ivadal

The main indications for the use of Ivadal are due to the need to treat transient and situational insomnia, which manifests itself in a complex of symptoms that occur in relation to all processes associated with sleep: falling asleep, sleep itself in its various phases, and awakenings - at night or too early.

The decision to prescribe a sleeping pill, including Ivadal, should be preceded by a comprehensive consideration of the existing factors in connection with sleep disorders and a thorough study of the patient's medical history. In the case of necessity, it may be appropriate to correct the causes that negatively affect healthy sleep processes, including medications.

If insomnia is observed for a period of one week to 14 days, during which appropriate treatment is carried out, this may serve as evidence of either a malfunction of the central nervous system, or suggests the presence of some primary mental disorder. In order to confidently state or, on the contrary, refute their existence in each specific case, it is necessary to record possible changes caused by this as a result of regular observation of the patient's condition.

Difficulty falling asleep, restless sleep and frequent night awakenings may be caused by the fact that a person is in a depressive state. Therefore, in order to determine the manifestations inherent in depression, it is necessary to assess the mental state of the person suffering from insomnia over certain periods of time.

Thus, indications for the use of Ivadal are justified in cases where it is necessary to achieve restoration of normal sleep processes, which are caused by situational and transient disorders. If insomnia appears as a consequence of certain anomalies of the mental sphere or psycho-emotional state of a person, then it is necessary to direct treatment to the underlying disease, the concomitant manifestation of which is sleep problems.

Release form

The release form of Ivadal is as follows.

This sleeping pill is available in the form of oblong tablets.

The tablets are covered with a film coating of white or almost white colour. There is a break line in the middle of each tablet, and on the surface of one side there is an imprint "SN 10".

One tablet contains zolpidem tartrate in the amount of 10 milligrams.

In addition to this main component, the composition includes:

• hypromellose,
• sodium carboxymethyl starch, type A,
• microcrystalline cellulose,
• lactose monohydrate,
• magnesium stearate.

The shell is formed by combining the components:

• hypromellose,
• titanium dioxide E171,
• macrogol 400.

The tablets are in blisters, which are placed in cardboard boxes.

Blisters contain 7, 10, 20 pieces respectively.

Depending on the number of tablets in a blister, the cardboard packs, together with a folded leaflet with instructions for use, contain:

• 1 blister of 7 tablets,
• 2 blisters of 10 pieces,
• one 20-tablet blister.

Pharmacodynamics

The pharmacodynamics of Ivadal is that its therapeutic doses after entering the body produce an effect consisting of reducing the time it takes to fall asleep. The effect of the drug also results in providing deeper and better quality sleep, which is a positive factor in reducing the frequency of night awakenings.

The peculiarity of the pharmacological action of the component zolpidem, which is fundamental to the beneficial properties of Ivadal, is the

The effect of increasing the duration of sleep at stage 2. This stage is characterized by a significant increase in the thresholds of perception of the senses, mainly hearing. Therefore, the better a person sleeps at stage 2, the less likely it is that any, even minor, random sounds can lead to sudden awakening. The effect of the drug is also that, thanks to it, the subsequent 3rd and 4th stages of sleep become longer, which are often combined under one designation - the so-called delta sleep. It is delta sleep or deep sleep that lasts most of the entire time of night rest. The quality and duration of this stage of sleep is very important for good rest, replenishment of the body's energy expenditure during the day, as well as strength, both physical and mental, and restoration of the nervous system.

Thus, the pharmacodynamics of Ivadal is characterized by the actualization under its influence in the body of primarily the hypnotic effect, and also sedative, muscle relaxant, amnestic, anxiolytic and anticonvulsant manifestations.

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Pharmacokinetics

Pharmacokinetics of Ivadal in relation to the process of absorption of the drug is manifested in the fact that the drug after oral administration has a bioavailability of 70%. In blood plasma, the maximum concentration is noted in the time interval from half an hour to 3 hours after entering the body.

Zolpidem is distributed linearly within the therapeutic dose range. To a significant extent (slightly more than 90%) it binds and forms a compound with proteins contained in blood plasma. The indicator characterizing the volume of distribution in adults is 0.54 ± 0.02 l / kg.
The drug is metabolized mainly in the kidneys - 60%, and in the intestinal tract - approximately 40 percent, as well as in the liver. It has such a specific feature relative to the latter as that under its action liver enzymes are not induced.

Zolpidem is eliminated after it is converted into inactive metabolites. The elimination half-life is typically approximately two and a half hours (0.7 to 3.5).

The elderly age of patients causes such a pharmacokinetic feature as a decrease in the liver clearance of this drug. The characteristic changes in values inherent in this are distinguished by a tendency to increase the maximum concentration by approximately half, while the half-life can be 3 hours. Changes towards a decrease also concern the volume of distribution. In elderly patients, it is 0.34 ± 0.05 l/kg.

During the administration of Ivadal by people with renal failure, it may be noted that the clearance of the drug is moderately reduced. This phenomenon does not depend on whether hemodialytic procedures were performed. Zolpidem is not removed during hemodialysis or other types of dialysis.

In case of liver dysfunction, the bioavailability of the drug increases, clearance is reduced, and the half-life increases to 10 hours.

The pharmacokinetics of Ivadal has a number of characteristic features and can appear differently in patients of different ages and in the presence of certain diseases in the anamnesis, which determines the specificity of the processes occurring in the body after taking this medicine.

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Dosing and administration

The method of administration and dosage of Ivadal involves its oral administration. The medicine should be taken as soon as possible before going to bed or while already in bed.

The dosage at the beginning of treatment should always be as minimal as possible to achieve the appropriate dose ratio and a sufficient measure of the beneficial effect it produces on the patient's condition. It should be noted here that in order to achieve such an optimal balance of drug doses and the strength and effectiveness of the effect it produces, one should never go beyond the upper limit of the maximum permissible amount per day. This value for adults is 10 milligrams.

In cases where there is liver dysfunction, in elderly patients and in a weakened state, the initial dose is halved - 5 mg. Exceeding the 10-milligram daily dosage is allowed only if the clinical effect of using the drug is insufficient. An important point here is that this becomes possible only if good tolerability of the drug is noted.

Treatment with Ivadal should be of a minimum duration: from several days to a 4-week course, with a period of dose reduction included in this time period. Courses of treatment exceeding the extreme regulated periods may be prescribed with extreme caution after repeated clinical assessment of the patient's condition.

Transient insomnia, such as that caused by time zone changes during travel, can be treated by taking the medication for 2 to 5 days. Situational insomnia, which can occur as a consequence of certain psychotraumatic situations, requires 2-3 weeks of treatment.

Short-term use of Ivadal does not require gradual withdrawal of the drug. After a long course of treatment, to avoid rebound insomnia, the dose should be gradually reduced at first until complete discontinuation of the drug.

The method of application and dosage regulate the basic rules and principles, adhering to which it becomes possible to achieve the maximum positive effect from Ivadal, and minimize the risk of occurrence of all kinds of accompanying negative phenomena.

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Use Ivadal during pregnancy

The use of Ivadal during pregnancy is included in the list of prohibited drugs during the first trimester of pregnancy. Currently, there is not enough reliable and unambiguous scientifically substantiated data confirmed by all the necessary studies on the use of this medication by pregnant women. Due to this, it is recommended to refrain from using Ivadal in the following 2nd and 3rd trimesters.

Here we cannot ignore the fact that high doses of the drug during the 2nd and 3rd trimesters can lead to such a harmful result as fetal freezing and cause changes in the frequency of its heart contractions. As for later terms, closer to the time when the resolution of labor should occur, even a small amount of active substances of the benzodiazepine group is fraught with the fact that the child may develop axial hypotension, arterial hypotension, apnea or transient respiratory depression, hypothermia, and disorders of the sucking reflex.

In addition, abuse of sleeping pills or sedatives in late pregnancy can lead to the formation of physical dependence in the child and the associated withdrawal syndrome in the postpartum period. This in turn causes increased excitability and tremors in the newborn, which may be observed some time after birth.

Zolpidem - the main component of Ivadal in some quantities can be excreted with the mother's breast milk during lactation. For this reason, the drug should also not be used during pregnancy and breastfeeding.

Women of reproductive age who use the drug, if they become pregnant or decide to plan a child, should consult a healthcare professional who will help determine whether the use of Ivadal during pregnancy is justified.

If the appointment of Ivadal in the 2nd and 3rd trimester of pregnancy is dictated by a high level of expediency, it is necessary to carefully weigh, compare and evaluate the ratio of the expected favorable result for the woman preparing to become a mother and the possible negative consequences for the normal development and health of the future baby.

Contraindications

Despite all the advantages and effectiveness of the drug in terms of improving the processes and quality of sleep, there are certain contraindications to the use of Ivadal, which we will consider below.

This sleeping pill is not suitable for use in cases of acute or severe respiratory failure, as well as sleep apnea syndrome.

To avoid the possibility of encephalopathy, Ivadal should be excluded from the list of medicinal prescriptions when there is chronic or acute liver failure.

The drug is not allowed to be used in children and adolescents under 18 years of age.

It is strongly recommended to refrain from using Ivadal throughout the first trimester of pregnancy.

The drug is considered unacceptable for prescription due to congenital galactosemia, galactose or glucose malabsorption syndrome, and lactase deficiency.

Another factor that determines the ban on the use of Ivadal is the presence of hypersensitivity to the components included in its composition.

Due to the fact that dependence on zolpidem may develop, special attention should be paid to cases in which the drug is prescribed to patients with severe pseudoparalytic myasthenia (asthenic bulbar palsy), and in addition to this, when there is liver dysfunction, chronic alcoholism, drug addiction or other types of dependence.

Sleeping pills based on the active component zolpidem are not included in the list of prescriptions for the main treatment of mental illnesses, and the use of Ivadal if there are symptoms of a depressive state of the patient, as well as other sedative and hypnotic pharmacological agents should be done with special caution.

Contraindications to the use of Ivadal, as it turns out, differ in a fairly wide range of cases in which the beneficial effect of its use can be significantly offset by the possibility of all sorts of accompanying negative phenomena. Therefore, before taking the drug, it is necessary to carefully weigh all the "Pros" and "Cons".

Side effects Ivadal

Side effects of Ivadal are largely determined by the doses of the drug and the individual reactions of the patient's body in each specific case. The central nervous system is especially susceptible to side effects, and mainly in elderly patients.

The negative response of the central nervous system to the use of Ivadal often becomes the appearance of excessive drowsiness, the occurrence of conditions similar to intoxication, headaches, dizziness. Instead of a beneficial effect on improving sleep processes, in some cases it can increase insomnia. Anterograde amnesia may develop, which is sometimes accompanied by behavioral disorders. The drug can also act as a hallucinogen, provoke nightmares during sleep, lead to confusion, excessive excitement and increased irritability.

The detrimental effect of Ivadal on the organs of vision may be the occurrence of diplopia, manifested in double vision of objects during visual perception.

The digestive system often responds to the effects of the drug with nausea, vomiting, abdominal pain and diarrhea.

Side effects of Ivadal also include muscle weakness, increased fatigue, excessive sweating, rashes and itching on the skin. It is possible to develop an allergic reaction in the form of urticaria, angioedema.

Thus, side effects can always take place, and in a fairly large number of their manifestations. In order for the beneficial effect produced by the drug to become most fully positive for the patient's condition rather than cause any undesirable consequences, its intake should be started only after consulting and following the recommendations of a medical specialist.

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Overdose

Symptoms that occur when the maximum permissible doses of the drug are exceeded are in the form of phenomena that arise as a result of CNS depression. Impaired consciousness may manifest itself in mild forms, in the form of inhibition and confusion, or be phenomena associated with the occurrence of severe impairment of consciousness, possibly even a comatose state.

Overdose of Ivadal is also associated with the risk of developing arterial hypertension and respiratory depression.

For treatment in a period of less than one hour after ingestion of an excessive dose of the drug, if the person has not lost consciousness, the first step is to induce vomiting. If this is impossible or if the patient is unconscious, it is necessary to wash the stomach. After more than one hour, a probe is inserted into the esophagus.

If the person is conscious, activated charcoal should be taken orally to reduce the absorption of zolpidem.

Therapy and treatment in case of overdose is symptomatic and aims to support the body's basic vital functions – the functioning of the respiratory and cardiovascular systems.

A severe overdose may require the use of a drug such as flumazenil, which is a benzodiazepine receptor antagonist. However, its use is associated with a risk of seizures. This risk is especially high in patients with epilepsy.

An overdose, either during the use of Ivadal itself or in combination with other drugs and substances that depress the nervous system, which also includes alcohol, can pose a threat to the patient’s life.

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Interactions with other drugs

The interactions of Ivadal with other drugs consist of a number of features of combinations in which the drug can exhibit certain adverse effects in the patient’s body.

It is unacceptable to use Ivadal in combination with ethanol. For the entire period of treatment with this drug, it is necessary to exclude medications containing ethyl alcohol, as well as to refuse alcohol consumption.

Great caution should be exercised when used in combination with drugs that depress the functions of the central nervous system - anxiolytic and sedative drugs, antidepressants with sedative properties, barbiturates, neuroleptics, morphine derivatives (such as cough suppressants and opioid analgesics). Combinations with antiepileptic drugs, sedatives with antihistamine properties, and pharmacological agents with central hypotensive action should require close attention.

The combination of Ivadal with Buprenorphine is a negative factor that causes an increased likelihood of respiratory depression, the most terrible consequence of which can be a fatal outcome.

When combined with ketoconazole, a potent CYP3A4 inhibitor, zolpidem somewhat enhances its sedative effect.

Rifampicin, being an inducer of CYP3A4, by accelerating the metabolic processes of zolpidem in the liver leads to a decrease in its effectiveness due to a decrease in its concentration in the blood plasma.

As we can see, interactions with other drugs can be very diverse. Some of them contribute to some enhancement of the positive effect it produces, while others, on the contrary, are capable of causing such changes in the pharmacological action of Ivadal that they reduce the effectiveness of its use in a certain way.

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Storage conditions

Storage conditions suggest that the drug should be kept in a place where a constant ambient temperature of no more than 25 degrees Celsius is maintained. Also, this storage place should be inaccessible to children.

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Shelf life

Shelf life: 4 years.