Iwadal

Iwadal is a pharmacological drug of sleeping pills belonging to imidazopyridines. According to the activity of the amnestatic, anxiolytic, myorelaxing, anticonvulsant and sedative effect produced, it has a similarity with the benzodiazepine group. Thanks to the use of the medicine, the duration of the sleep period is reduced, the number of awakenings decreases, the sleep becomes longer and has a better quality.

The medicine possesses the necessary necessary qualities, allowing with all the grounds to classify it as the "ideal sleeping pills". Once taken, even in the minimum required dose, it ensures a rapid falling asleep, and the increase in dosage does not lead to an increase in the strength of its action. This is a deterrent for those who suffer from insomnia, preventing their self-increasing doses of the drug. Due to the use of this hypnotic, a person wakes up much less frequently at night. The medicine does not cause significant changes in the structure and stages of sleep. Its influence on wakefulness level during awakening, memory, cognitive functions and reaction speed is minimal. A cessation of reception is not associated with the appearance of any deterioration in the patient's condition. 

Due to this, the medication is deservedly a recognized leader in the world market of pharmacological agents aimed at normalizing the processes of healthy sleep. If there are any problems with sleeping, whatever, there is a problem with the use of Iwadal, it really becomes a full time of the night rest of the body from all the stressful modern rhythm of life, problems and all sorts of stressful situations that a person can face during the day. 

Indications Iwadal

The main indications for Iwadal are conditioned by the need to treat insomnia of a transient and situational nature that manifests itself in a complex of symptoms occurring in relation to all processes associated with sleep: falling asleep, actually sleeping in its various phases, and awakening - at night or too early.

Decision on the prescription of sleeping pills, including Ivadal, should be preceded by a thorough consideration of the available factors in connection with sleep disturbances and careful study of the patient's medical history. In sprparluchae need, there may be a reason to implement correction of the causes of the negative impact on the processes of healthy sleep, including medication.              

If insomnia is observed during the period from one week to 14 days during which appropriate treatment is carried out, it can act as evidence of or malfunction of the central nervous system, or suggests the presence of any primary mental disorder. To state with confidence or, on the contrary, to refute their existence in each specific case, respectively, it is required as a result of regular monitoring of the patient's condition to fix possible changes caused by this.        

Difficulties in falling asleep, restless sleep, and frequent nocturnal awakenings can cause a person to be depressed. Therefore, to determine the manifestations of inherent depression, it is necessary to assess the state of the psyche of a person suffering from insomnia at certain time periods.    

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

[1]

Release form

The form of Iwadal is as follows.

This medication of sleeping pills is transferred in the form of tablets of oblong form.

The tablet is coated with a film shell that is white or almost white in color. In the middle of each tablet there is a fault line, and on the surface of one side there is an impression "SN 10".

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

In addition to this main component, the structure includes:

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

The shell is formed by the combination of components:

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

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

Blisters contain 7, 10, 20 pieces, respectively.

Depending on the number of tablets in the blister in the cardboard bundles along with the folded sheet of instructions for use are:

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

[2]

Pharmacodynamics

Pharmacodynamics Iwadal lies in the fact that its therapeutic doses after they enter the body produce the effect of reducing the time of falling asleep. The result of exposure to the medication is also the provision of a deeper and better sleep, which is a positive factor for reducing the incidence of nocturnal awakenings.       

A feature of the pharmacological action of the component zolpidem, which is fundamental in the beneficial properties of Iwadal, is the one produced by it

The effect of increasing the duration of sleep in the 2 nd stage. This stage is marked by a significant increase in the threshold of perception of the sensory organs, mainly the hearing. Therefore, the better a person sleeps in the 2 nd phase, the less likely is that any, even minor, random sounds can lead to a sudden awakening. The action of the drug is also due to the fact that the subsequent 3 rd and 4 th stages of sleep become more frequent, which are often combined within the same designation - the so-called delta sleep. It is delta sleep or deep sleep that lasts most of the time at night. The quality and duration of this stage of sleep is very important for a good rest, replenishing the energy costs of the body for the day, as well as forces, both physical and mental, and restoring the nervous system.

So, the pharmacodynamics of Ivadal is characterized by the actualization, in the first place, of the hypnotic effect, in addition to the sedative, myorelaxing, amnestic, anxiolytic and anticonvulsant manifestations. 

[3], [4]

Pharmacokinetics

Pharmacokinetics Iwadal regarding the process of absorption of the drug is manifested in the fact that the drug after ingestion has a bioavailability of 70%. In plasma, the maximum concentration is noted in the time interval from half an hour to 3 hours after ingestion.    

Zolpidem is distributed linearly within the therapeutic range of doses. To a large extent (slightly more than 90%) enters into connections and forms a connection with the proteins contained in the blood plasma. The indicator characterizing the extent to which the distribution occurs in adults is 0.54 ± 0.02 l / kg.
Metabolism drug is mainly in the kidneys - 60%, and in the intestinal tract - about 40 percent, as well as in the liver. Has such a specific feature regarding the latter, such that under its action hepatic enzymes are not induced.

Elimination of zolpidem occurs after it is transformed into inactive metabolites. The half-life process takes, as a rule, approximately two and a half hours (from 0.7 to 3.5). 

The elderly age of patients causes such a feature of pharmacokinetics as a decrease in the hepatic clearance of this drug. The inherent characteristic changes in the values differ in the tendency to increase the maximum concentration by about half, while the duration of the half-life can be 3 hours. Changes in the direction of decrease in this case also concern the volume of distribution. It is 0.34 ± 0.05 l / kg in elderly patients.

During the adoption of Ivadal by people who have renal insufficiency, it can be noted that the clearance of the drug is moderately reduced. Such a phenomenon does not reside in any dependence on whether hemodialytic procedures have been performed. The withdrawal of zolpidem during hemo dialysis or other dialysis does not occur.       

With liver dysfunction, the bioavailability of the drug increases, the clearance is decreased, and the elimination half-life increases to 10 hours. 

Pharmacokinetics Iwadal has a number of characteristic features and is able to appear differently in patients of different ages and with a history of certain diseases, what determines the specificity of the processes occurring in the body after taking this medication.    

[5]

Dosing and administration

The method of administration and dose of Ivadal suggest its oral ingestion. The medicine should be taken in the shortest time, before going to bed or immediately being in bed.

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

In those cases where there is hepatic dysfunction, in elderly patients and in a weakened state the initial dose is reduced by half - 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 also that it becomes possible only if a good tolerance of the drug is noted.   

Treatment with Ivadal should have a minimum duration: from several days to a 4-week course, including a period of dose reduction during this time interval. Treatment rates exceeding the deadlines can be prescribed with extreme caution after a repeated clinical assessment of the patient's condition is made.   

With transient insomnia arising, say, in connection with the change of time zones during the journey, will help to cope with taking the medication for from 2 to 5 days. Situational insomnia that can arise as a consequence of certain psychotraumatic situations requires a 2-3-week treatment.     

Periods of use Iwadal for a short time does not require the gradual withdrawal of the drug. After a long course of treatment, in order to avoid the appearance of ricochet insomnia, the doses should first be reduced gradually until the reception is completely stopped. 

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

[8], [9], [10]

Use Iwadal during pregnancy

Use of Iwadal during pregnancy refers to a list of drug prohibitions that are unacceptable during the first trimester of gestation. At present, there are not enough reliable and unambiguous scientifically grounded data confirmed by all necessary studies for the use of this medication by pregnant women. Therefore, from the use of Iwadal it is recommended to abstain also in the subsequent 2nd and 3rd trimester.  

Here one can not ignore the fact that high doses of medication during the 2nd and 3rd trimester can lead to such a harmful result as fetal fading and cause changes in the frequency of his heartbeats. With regard to later terms, then closer to the time when the birth permit should be approached even by 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, disturbances of the sucking reflex .

In addition, the abuse of hypnotic or sedative drugs in late pregnancy can lead to the formation of a child's physical dependence and associated withdrawal syndrome in the postpartum period. This, in turn, is the cause of increased excitability, tremor of the newborn, which can be observed after a certain time after delivery.        

Zolpidem - the main component of Iwadal in a certain amount can be allocated together with the breast milk of the mother during lactation. For this reason, the use of the drug during pregnancy and lactation should also not be resorted to.   

Women of reproductive age who use the drug, if they have a pregnancy or have decided to plan a child, should consult a medical specialist who will help determine whether it is justified to use Iwadal during pregnancy.

If the appointment of Iwadal 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 outcome for the woman preparing to become a mother and possible negative consequences for the normal development and health of the future baby.    

Contraindications

With all the merits and effectiveness of the drug in terms of improving the processes and quality of sleep, there are certain contraindications to the use of Iwadal, which we consider below.

This hypnotic is unacceptable 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 medications when there is a chronic or acute liver failure.

It is not allowed to use the drug against children, as well as adolescents under 18 years.  

It is strongly recommended to refrain from applying Iwadal throughout the first trimester of pregnancy.

The drug is considered unacceptable for the purpose because of congenital galactosemia, malabsorption syndrome of galactose or glucose, deficiency of lactase.

The factor that determines the ban on the use of Iwadal is also the presence of increased sensitivity to the constituent components.

In view of the fact that dependence on zolpidem can form, attention should be paid to cases in which the drug is prescribed for patients with severe pseudo-paralytic myasthenia gravis (asthenic bulbar paralysis), and in addition, when hepatic dysfunction occurs, chronic alcoholism, drug addiction or other addictions are noted.     

Drugs of hypnotics based on the active component of zolpidem are not included in the list of prescriptions for the main treatment of mental illness, and if Iadal has symptoms of depressive state of the patient, as well as other sedative and hypnotic pharmacological agents should be done with extreme caution.   

Contraindications to the use of Ivadal, it is clear, differ in a fairly wide range of cases in which a favorable effect on its use can be substantially offset by the possibility of all accompanying negative phenomena. Therefore, before taking the drug, you must carefully weigh all the "For" and "Against". 

[6]

Side effects Iwadal

Side effects of Iwadal are largely conditioned by the doses of the drug and the individual reactions of the organism of the patient in each particular case. Particularly prone to the occurrence of side effects of the central nervous system, and mainly in patients in old age.

In response to the negative response of the central nervous system to the application of Ivadal, there is often the appearance of excessive drowsiness, there are conditions similar to intoxication, headaches, dizziness. Instead of a beneficial effect on the improvement of sleep processes, in some cases it can increase insomnia. There can be a development of anterograde amnesia, which is sometimes accompanied by behavioral disorders. The drug is also able to act as a hallucinogen, to provoke nightmares during sleep, lead to confusion, excessive excitement and increased irritability.

The harmful effect of Ivadal on the organs of vision can be the emergence of diplopia, manifested in the doubling of objects in visual perception.               

The digestive system on the effect of the drug often responds with the appearance of nausea, vomiting, abdominal pain and diarrhea.  

A side effect of Ivadal's application is also a weakness in the muscles, increased fatigue, excessive sweating, rash and itching on the skin. Perhaps the development of an allergic reaction in the form of hives, angioedema.    

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

[7]

Overdose

The symptomatology arising in the case of exceeding the maximum allowable doses of the drug occurs in the form of phenomena that arise as a result of CNS depression. Disturbances of consciousness can manifest themselves in mild forms, in the form of inhibition and confusion of consciousness, and represent phenomena associated with the onset of severe disorders of consciousness, perhaps even a coma.         

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

For treatment during a period of less than one hour after ingestion of an excessive dose of the drug, if a person has not lost consciousness, the primary action is to induce vomiting. In case of impossibility of that or at an unconsciousness of the patient it is necessary to spend lavage of a stomach. After a lapse of more than one hour, a probe is inserted into the esophagus.

If a person is conscious, he should take activated charcoal inside to reduce the absorption of zolpidem.

Therapy and treatment for overdose is symptomatic and aims to maintain the basic functions of the body - the work of respiratory and cardiovascular systems.

An overdose of a large degree of severity may become topical in deciding on the use of a drug such as flumazenil, which is an antagonist of benzodiazepine receptors. However, its use is associated with a risk of seizures. This probability is especially high in patients with epilepsy.   

Overdosing, both during the intake of Iwadal itself, and in combination with other drugs and substances depressing the nervous system, including alcohol, can pose a threat to the life of the patient.

[11], [12], [13]

Interactions with other drugs

The interaction of Iwadal with other drugs is a number of features of combinations in which the drug may exhibit some of its adverse effects in the patient's body.

It is unacceptable to use Iwadal in combination with ethanol. For the entire period of the course of treatment with the use of this drug, it is required to exclude drugs containing ethyl alcohol, as well as to refuse to drink alcohol.

With great caution, one should approach joint use with medications that depress central nervous system functions - anxiolytic and sedative drugs, antidepressants with sedative properties, barbiturates, neuroleptics, morphine derivatives (such as cough and opioid analgesics). Close attention should be given to a combination with antiepileptic drugs, sedative antihistamine drugs, pharmacological agents of central antihypertensive action.               

The combination of Iwadal with buprenorphine is a negative factor causing an increase in the likelihood of respiratory function depression, the most terrible consequence of which can be fatal.    

Forming a combination with ketoonazole, a powerful inhibitor of CYP3A4, zolpidem enhances to some extent the sedative effect it produces.    

Rifampicin, being the inducer of CYP3A4, due to the acceleration of 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 you can see, interactions with other drugs can be very diverse. Some of them contribute to some enhancement of the positive effect produced by them, others, on the contrary, are capable of causing such changes in the pharmacological action of Iwadal, which in a certain way reduce the effectiveness of its application. 

[14], [15], [16]

Storage conditions

Storage conditions suggest that the drug should be in a place in which a constant temperature of the medium does not exceed 25 degrees Celsius. Also, this storage location should not be accessible to children.  

[17], [18]

Shelf life

Shelf life - 4 years.