Ivadal is an imidazopyridine hypnotic drug that has anticonvulsant, muscle relaxant, anxiolytic, sedative and amnestic properties.
Release form and composition
Ivadal is produced in the form of coated tablets, packaged in blisters of 7, 10 or 20 pcs.
The active ingredient of the drug is zolpidem (in the form of tartrate), its concentration in a single tablet is 10 mg.
Auxiliary components are: hypromellose, sodium carboxymethyl starch, magnesium stearate, lactose monohydrate and microcrystalline cellulose.
The composition of the tablet coating shell: hypromellose, macrogol 400 and titanium dioxide.
Indications for use
Ivadal is used for situational and transient disorders of sleep in adults, including difficulty falling asleep, night and early awakenings.
Do not prescribe the drug:
- Children and teenagers under 18;
- During lactation;
- In the first trimester of pregnancy.
Ivadal is contraindicated in:
- Acute or severe respiratory failure;
- Congenital galactosemia;
- Sleep apnea syndrome;
- Acute and severe liver failure;
- Lactase deficiency;
- Glucose-galactose malabsorption syndrome;
- Hypersensitivity to zolpidem or any auxiliary component.
Caution in applying Iwadal should be observed in patients with:
- Severe pseudoparalytic myasthenia;
- Drug addiction and other forms of addiction;
- Impaired liver function;
- Chronic alcoholism.
If Ivadal is contraindicated categorically in the first trimester of pregnancy, it can be prescribed in the second and third trimesters, but only in cases of emergency if the expected benefit for the expectant mother exceeds the potential risks to the fetus.
Dosing and Administration
As indicated in the instructions, Ivadal should be taken once a day, just before bedtime.
The recommended single (and at the same time daily) dose for an adult patient is 10 mg of zolpidem (1 Ivadal tablet).
To reduce the dosage in half (up to 1/2 table) is necessary for older and weakened people, as well as for patients with impaired liver function. And only with insufficient clinical effect, but provided that the drug is well tolerated in this category of patients, the dose can be increased to 10 mg.
In case of transient insomnia (for example, due to a change in the situation during the trip), the drug can be taken for no more than 5 days. In case of situational insomnia (for example, caused by a traumatic situation) - within 2-3 weeks.
The duration of treatment should be minimal. The maximum allowable duration of Iwadal is 3 weeks + 1 week for dose reduction, i.e. only 4 weeks, including a period of gradual withdrawal of the drug. Longer therapy can be prescribed only after re-clinical assessment of the patient's condition.
It should be noted that in the case of a short reception (up to 5 days) gradual withdrawal of the drug is not required. But with long courses it is possible to develop rebound insomnia, so the treatment is stopped by gradually reducing the dose - first, it is halved and only then canceled by Ivadal.
Adverse reactions, especially on the part of the central nervous system, depend on the dosage and individual response of the patient. Most often observed in older people, and their severity decreases when taking Iwadal just before bedtime or already in bed.
The most common side effects of the drug are:
- Headache, agitation, drowsiness or aggravation of insomnia, dizziness, intoxication, nightmares, hallucinations;
- Nausea and / or vomiting, abdominal pain, diarrhea.
Rarely, but in some cases such side effects are noted:
- Dysphoria, irritability, anterograde amnesia, impaired consciousness, excitability, aggressiveness, somnambulism, gait disturbance, behavioral abnormalities, decreased sexual desire, confusion, falls (more often observed in elderly patients who do not adhere to the doctor's recommendations), addiction to the drug, manifested a decrease in the hypnotic effect (usually with prolonged use);
- Excessive sweating, urticaria, rash, pruritus, angioedema;
- Increased liver enzymes;
- Muscle weakness;
- Increased liver enzymes;
- Feeling tired
With the abrupt cancellation of the drug after a long reception, even in therapeutic doses, drug dependence may develop, which is manifested by rebound insomnia or withdrawal syndrome.
Overdose as zolpidem alone, as well as in combination with other drugs that have a depressant effect on the central nervous system (including alcohol), can be dangerous to human life. Its symptoms manifest as impaired consciousness from mild forms (inhibition and confusion) to severe (coma), arterial hypotension, ataxia, and respiratory depression.
If after taking a too high dose less than 1 hour has passed, and the person is conscious, it is necessary to induce vomiting. If this is not possible, or the patient is unconscious, it is recommended to do a gastric lavage. If, after the accidental or deliberate ingestion of a large dose of zolpidem, more than 1 hour has passed, it is necessary to give the patient (or enter through a probe if he is unconscious) activated charcoal. Further, in a hospital, symptomatic therapy is prescribed, primarily aimed at maintaining the basic functions of the body, in particular cardiovascular and respiratory. Hemodialysis is ineffective. In severe overdose of zolpidem, flumazenil (a benzodiazepine receptor antagonist) may be required. This measure is taken in cases of extreme necessity, because flumazenil can cause neurological disorders (including convulsions), especially in patients with epilepsy.
Before the appointment of a sleeping pill, it is always necessary to establish the cause of sleep disorders and correct the underlying causes. Continued insomnia for 7–14 days indicates that there are primary psychotic disorders and / or disorders of the nervous system. Therefore, it is important to regularly reassess the patient's condition.
With extreme caution, the sleeping medicine should be used for depression. It should not be prescribed as a single agent, since Ivadal may mask the symptoms of depression, and the disease may develop with an increase in suicidal tendencies.
Ivadal should be taken only at bedtime. This is due to the fact that zolpidem can cause anterograde amnesia, most often occurring several hours after taking the drug.
The risk of addiction increases with prolonged treatment and / or in high doses, as well as in patients who in the past have abused alcohol or other drugs and non-medicinal substances. Such people during the period of therapy should be under especially careful medical supervision.
Zolpidem can not be taken in combination with benzodiazepines, because increases the risk of addiction.
In some cases, Ivadal may cause drowsiness and dizziness. If, after taking the drug, the duration of sleep was not sufficient, the risk of psychomotor disturbances increases. This should be considered by people driving a vehicle and engaging in potentially hazardous activities.
During treatment Ivadalom is forbidden to consume alcoholic beverages and take medicines containing ethanol.
If possible, you should avoid combining zolpidem with buprenorphine and pizothiphene, because When you receive this combination, the risk of respiratory depression, or even death, is significantly increased.
It is not recommended to combine with Ivadal and the following drugs:
- Other hypnotics;
- Antidepressants with a sedative effect;
- Antihistamines with sedative effect;
- Antiepileptic drugs;
- Morphine derivatives (antitussives and opioid analgesics);
- Means for anesthesia;
- Antihypertensive drugs of central action.
- According to the active substance: Zolpidem, Hypnogen, Zolsana, Nitrest, Zonadin, Oniria, Snovitel and Sanval;
- According to the mechanism of action: Zopiclone, Andante, Imován, Relaxax, Somnol, Piklodorm, Thorson, Slipwell.
Terms and conditions of storage
It is necessary to store Ivadal at a temperature up to 25 ºС in a dry, dark place. Shelf life - 4 years.