Universal reference book for medicines
Product name: ONIRIA (ONIRIA)

Active substance: zolpidem

Type: Soporific drug

Manufacturer: ITALFARMACO (Italy)
Composition, form of production and packaging
Drops for ingestion
as a clear, colorless or light yellow solution.

1 ml

zolpidem tartrate 10 mg

Excipients: citric acid monohydrate 20 mg, sodium benzoate 0.25 mg, sodium hydroxide to pH 4.0, hydrochloric acid to pH 4.0, water purified to 1 ml.

30 ml - bottles of orange glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Zolpidem is a hypnotic, which belongs to the group of imidazopyridines.
Differing in structure from benzodiazepines, zolpidem has a sedative effect, while anxiolytic, anticonvulsant and central miorelaksiruyuschee effect is expressed slightly.
The effect comes quickly.
Zolpidem is rapidly absorbed from the digestive tract.
According to the classification allosteric sections of the complex of? -aminobutyric acid (GABA), with which benzodiazepines bind, are called co-modulating sites or receptors.
To date, three subtypes have been identified:? 1 ? 2 and? 3 . Unlike benzodiazepines, which unselectively bind and activate all three subtypes of? -receptors, zolpidem selectively binds to? 1- receptor, therefore, the sedative effect of the drug is observed at lower doses than the doses necessary for the development of myorelaxing, anticonvulsant and anxiolytic effect.
?
1 -receptors are mainly located in the fourth layer of the sensory cortex of the cerebral hemispheres, in the cerebellum, the variolium bridge, and the lower tubercles of the quadruple. Zolpidem showed a low affinity for? 2- receptors (lumbar spine, hippocampus) and? 3 receptors (certain peripheral regions). The pharmacological action of zolpidem differs from that of benzodiazepines. Interaction with? -receptors leads to the discovery of neuronal ion channels of chlorine.
Shortens the time of falling asleep., Reduces the number of nocturnal awakenings, increases the total duration of sleep and improves its quality.
Lengthens the II stage of sleep and the stage of deep sleep (III and IV).
PHARMACOKINETICS

After taking the dose, 5 mg and 10 mg of C max are respectively 59 mg / ml and 121 ng / ml, TC max from 0.5-3 hours (mean TC max 1.6 hours).

When there is food in the stomach, the absorption of zolpidem slightly slows down.
To accelerate the onset of sleep, zolpidem should not be taken concurrently or immediately after meals. The pharmacokinetics of zolpidem remains unchanged for several weeks of use.
Bioavailability of zolpidem reaches 70%, the connection with plasma proteins is 92%.

There is a linear relationship between the dose of the drug and the concentration of zolpidem in the plasma.

Metabolized in the liver with the formation of three inactive metabolites, which are excreted by the kidneys (about 60%) and through the intestine (about 40%).

T 1/2 of zolpidem is between 0.7-3.5 hours (on average about 2.4 hours).

The total clearance of zolpidem is 0.26 l / h / kg, the volume of distribution is 0.54 l / kg.

Does not induce microsomal liver enzymes.
Do not cumulate.
In elderly people, clearance in the blood plasma can decrease without a significant increase in T 1/2 , (on average 3 hours), while C max increases by 50%.
In patients with severe renal failure, the clearance does not increase significantly. In patients with hepatic insufficiency, bioavailability increases, T 1/2 increases to 10 h.
INDICATIONS

Sleep disorders:

- difficulty falling asleep;

- early and nocturnal awakenings.

DOSING MODE

The bottle is equipped with a dropper.
1 ml corresponds to 25 drops, which is equivalent to 10 mg of zolpidem.
Drops for ingestion should be taken with the liquid (water) just before bedtime.

The duration of treatment should be as short as possible.
On average, it should be from a few days to two weeks and should not exceed 4 weeks, including the cancellation period. Cancellation should take place taking into account the individual characteristics of the patient.
In the case of long-term use of the drug to reduce the possibility of a "ricochet" insomnia, the abolition of zolpidem should be gradual (first a decrease in the daily dose and then a drug withdrawal).

Adults

The recommended daily dose is 10 mg (25 drops).
The daily dose of zolpidem should not exceed 10 mg.
SIDE EFFECT

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1 / 10000 to <1/1000) and very rarely (<1/10000), including individual messages;
the frequency is unknown - based on the available data, the frequency of occurrence can not be determined.
The frequency of most side effects depends on the dose.
Side effects are more common in women than in men.
From the central and peripheral nervous system:

Often: drowsiness, a feeling of intoxication, headache, dizziness, increased insomnia, anterograde amnesia (the effects of amnesia can be associated with behavioral reactions), the risk of developing it increases in proportion to the dose, hallucinations (including visual and auditory), increased excitability, "nightmarish" dreams, emotional lability, vertigo, ataxia.

Infrequent: migraine, parasthesia, tremor, confusion, decreased concentration of attention (with insufficient sleep time), irritability, euphoria.

Rarely: aggressiveness, delirium, psychotic disorders, somnambulism, inadequate behavior and other behavioral disorders (these reactions occur more often in the elderly).

Very rarely: anger.

The frequency is unknown: dysphoria, behavioral disorders, drug dependence (can develop including when taking therapeutic doses), when the drug is canceled, the "cancellation" or "ricochet" syndrome insomnia, decreased libido, addiction to the drug (reduction of sedative and hypnotic effects when applied in a few weeks).Most side effects from the psyche are paradoxical reactions.

From the digestive system:

Often: diarrhea.

Infrequently: nausea, vomiting, abdominal pain, dysphagia, flatulence, hiccough, gastroenteritis.

Rarely: increased activity of hepatic enzymes.

From the musculoskeletal system:

Not very often: muscle weakness, arthritis.

From the skin and subcutaneous fat:

Infrequent: rash, itching, hives, increased sweating.

Rarely: pallor, swelling of the Quincke.

On the part of the organs of vision:

Infrequently: diplopia.

From the cardiovascular system:

Infrequently: tachycardia, cerebrovascular disorders, increase and decrease in blood pressure, orthostatic hypotension.

On the part of the respiratory system:

Infrequent: bronchitis, cough, shortness of breath.

From the endocrine system:

Infrequently: hyperglycemia.

Other:

Often: feeling tired.

Infrequent: trauma, falls (mainly in elderly patients), peripheral edema, fever.

If any undesirable phenomena not listed in these instructions for use appear, you should consult your doctor.

CONTRAINDICATIONS

- Hypersensitivity to zolpidem and other auxiliary components of the drug;

- severe acute or chronic liver failure;

- sleep apnea syndrome;

- severe respiratory failure;

- I trimester of pregnancy and lactation period;

- age under 18 years (efficiency and safety not established).

With care: liver failure of mild and moderate severity, depression, alcoholism, drug addiction and other addictions, second and third trimesters of pregnancy, respiratory failure of mild and moderate degree, grave gravis gravis, patients with mental illness.

PREGNANCY AND LACTATION

The drug Oniria is contraindicated in the first trimester of pregnancy.
If you need to administer Oniria in the II and III trimesters of pregnancy, you should carefully evaluate the expected benefit of therapy for the mother and the potential risk to the fetus and newborn. In studies on animals, the teratogenic and embryotoxic effect of the drug was not detected.
Women of reproductive age who take the drug should be warned about the need to see a doctor in the case of a planned or onset of pregnancy, and during treatment with Oniria, patients should use reliable contraceptive methods.

In the case of zolpidem at the end of pregnancy or during labor (even at low doses), hypothermia may develop in the newborn, transient respiratory depression or apnea, axial hypotension, lower blood pressure, and sucking disorders.

In addition, children born to mothers who took sedatives / hypnotics for a long time at the end of pregnancy may become physically addicted, and there is a risk of developing a "cancellation" syndrome in the postnatal period.
Zolpidem penetrates into breast milk, therefore it is contraindicated for use during breastfeeding. If you need to use the drug Oniria during lactation, breastfeeding should be discontinued.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution in liver failure of mild to moderate severity.

APPLICATION FOR CHILDREN

Contraindicated up to 18 years.

APPLICATION IN ELDERLY PATIENTS

When prescribing benzodiazepines and related compounds, elderly patients need to be cautious about the risk of developing sedative and / or muscle relaxant effects, which can lead to falls with serious consequences.

Patients should always be warned about the recommended duration of treatment, which is determined by the type of insomnia.

SPECIAL INSTRUCTIONS

In all cases, before the appointment of a sleeping pill, one should establish the cause of sleep disorders and correct (including medicamental) causes underlying them.Preservation of insomnia within 7-14 days of treatment indicates the presence of primary mental disorders and / or disorders of the nervous system.
Therefore, in order to identify these disorders, the patient's condition must be reassessed regularly.
Mental diseases

Sleeping pills, such as zolpidem, are not recommended as the main treatment for mental illness.

Depression

The use of zolpidem in patients with symptoms of depression, as well as other drugs with sedative / hypnotic effects, requires special care.
Such patients should be treated for depression and do not prescribe benzodiazepines and their close-to-effect drugs in monotherapy, because these drugs can mask symptoms of depression that can continue to develop against their background while maintaining or increasing suicidal tendencies. In connection with the fact that the cause of insomnia may be depression, then in case of persistent insomnia persistence, a repeated assessment of the patient's mental state should be conducted in order to identify possible depression.
Amnesia

Sedatives / hypnotics, such as zolpidem, can cause anterograde amnesia.
This condition is most often observed a few hours after taking the drug and therefore to reduce the risk of its development, patients should have conditions for a continuous 8-hour sleep.
Mental and "paradoxical" reactions

As is known with the use of sedatives / hypnotics, incl.
and zolpidem, the following conditions may occur: increased insomnia, nightmares, agitation, nervousness, delirium, hallucinations, confusion and onyricism, psychotic symptoms, disinhibition with impulsivity, euphoria, increased excitability, anterograde amnesia, increased suggestibility, aggressiveness.
These reactions can be accompanied by the following potentially behavioral disorders that are potentially dangerous for the patient or others: unusual for the patient behavior with the phenomena of automatism, autoaggression or aggression towards others, followed by amnesia.

If these effects occur, zolpidem should be discontinued.
The probability of occurrence of these effects is higher in elderly patients.
Somnambulism and related complex behavior

In some people, benzodiazepines and related drugs can cause a syndrome of combined disorders of consciousness, behavior and memory of varying degrees of severity.
In patients receiving zolpidem, there was walking in sleep and other related complex behavior: driving in a sleepy state, cooking and eating, phone calls, the commission of sexual intercourse with incomplete awakening with amnesia of these actions. Taking alcohol and other drugs with CNS depressant together with zolpidem, as well as taking zolpidem at doses exceeding the recommended dose, apparently increases the risk of such behavior. If the patient reports an episode (s) of this behavior, the Onia medication should be discontinued.
Addiction

After a course of taking sedative / hypnotic drugs like zolpidem for several weeks, some reduction in their sedative and hypnotic effects is possible.

Formation of dependence

The use of benzodiazepines and related drugs, especially prolonged ones, can lead to the formation of physical and / or mental dependence.
The risk of dependence is increased with an increase in the dose of the drug and the duration of treatment, it is also higher in patients with alcoholism or the abuse of other drugs and non-medicinal substances in the anamnesis. Such patients should be monitored carefully when receiving sleeping pills.
However, dependence can also occur with the use of therapeutic doses and / or in patients without individual risk factors.

When using the drug Oniria in therapeutic doses, dependence on the drug is extremely rare.

In the case of dependence on the drug Oniria, upon termination of its administration, the development of the "withdrawal" syndrome is possible, the common symptoms of which are: insomnia, headache and myalgia, dysphoria, anxiety, muscle tension and irritability.
Less often (in more severe cases of the "cancellation" syndrome), there is agitation or even episodes of confusion, derealization, depersonalization, numbness and paresthesia of the extremities, excessive sensitivity to light, noise, physical contact, hallucinations and convulsions.
The syndrome of "cancellation" can be observed for several days after the termination of treatment with the drug Oniria.
When taking zolpidem (as well as other short-acting benzodiazepines), there may be symptoms of the "cancellation" syndrome in the interval between two doses, especially in high doses.
Regardless of the indications for use, the combination of zolpidem with benzodiazepines increases the risk of dependence.
There are reports of drug abuse cases.
"Ricochet" insomnia

Transient syndrome with the abolition of sleeping pills as a return to insomnia in a strengthened form.
It can be combined with other reactions, including mood changes, anxiety and dysphoria. It is important that the patient be warned about the possibility of a "bounce" phenomenon, which will reduce the anxiety about the occurrence of such symptoms when the drug is discontinued.
Risk of cumulation

Benzodiazepines and related compounds remain in the body for approximately five half-lives.
In elderly patients or in patients with liver failure, a significant increase in T 1/2 is possible, which may lead to cumulation of zolpidem in its repeated administration. Based on the features of pharmacokinetics of zolpidem, cumulation is not expected in renal failure.
Use in elderly patients

When prescribing benzodiazepines and related compounds, elderly patients need to be cautious about the risk of developing sedative and / or muscle relaxant effects, which can lead to falls with serious consequences.

Patients should always be warned about the recommended duration of treatment, which is determined by the type of insomnia.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment with Onriia, caution must be exercised when managing transporeal means and engaging in other potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

If the duration of sleep was not sufficient after taking Onriia, the risk of disturbances in psychomotor reactions increases, which may pose an additional hazard in the management of transport and other potentially hazardous activities.

OVERDOSE

In case of an accidental overdose with Onario, the doctor should be consulted immediately.
Symptoms are mainly caused by depression of the central nervous system: there are possible disorders of consciousness from mild forms (confusion, inhibition) to severe (up to coma), ataxia, lowering blood pressure, respiratory depression, life-threatening patient.
Treatment: if after taking an excessive dose less than 1 hour has passed and the patient is conscious, vomiting should be attempted.
If it is not possible to induce vomiting, or in the case of an unconscious patient, gastric lavage is recommended. If after an accidental or deliberate administration of an excessive dose of the drug, more than 1 hour has elapsed, the patient should be allowed to take or inject through the probe (in the unconscious state) activated charcoal to reduce the absorption of zolpidem.
In overdose being symptomatic therapy (in a hospital) and treatment aimed at maintaining the basic functions of an organism, in particular the functions of respiration and the cardiovascular system.
Sedative drugs should not be used after zolpidem overdose, even when agitation occurs.
In the case of severe overdose for differential diagnosis and / or treatment should consider the introduction of flumazenil in the hospital (antagonist of benzodiazepine receptors), but it should be remembered that inhibition of benzodiazepine receptors can cause neurological disorders (seizures), especially in patients with epilepsy. Zolpidem is not displayed by hemodialysis.
DRUG INTERACTION

Before taking this medication the patient should inform the doctor about all the medications he takes, including non-prescription.
Not recommended combinations: Ethanol enhances the sedative effect of zolpidem.
Combinations requiring caution in use: Medicines (PM), CNS depressants (neuroleptics, barbiturates and other hypnotics, anxiolytics / sedatives, antidepressants with sedative, narcotic analgesics, antitussives central action), antiepileptics, drugs for general anesthesia, H blockers 1histamine receptors with sedation, centrally acting antihypertensives; baclofen; thalidomide; pizotifen - increased inhibitory action on the central nervous system and the risk of respiratory depression. Buprenorphine - the risk of respiratory depression.
Ketoconazole (a potent inhibitor of isozyme CYP3A4) 200 mg 2 times a day, and ritonavir increased T 1/2 , area under the curve "concentration-time" and reduce the clearance of zolpidem (possibly increasing sedation zolpidem).
Itraconazole (an inhibitor of the isoenzyme CYP3A4) - a small, clinically insignificant change in the pharmacokinetics and pharmacodynamics of zolpidem.
Interactions which should be taken into account:
Rifampicin (inductor isoenzyme CYP3A4) accelerates metabolism, reduces the concentration and, consequently, the efficiency of zolpidem.
Flumazenil eliminates the hypnotic effect of zolpidem.
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not higher than 25 ° C, protected from light. Store 60 days after the first opening of the vial.
Keep out of the reach of children. Shelf life - 2 years.
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