Sonovan (melatonin) 3 mg, 30 pcs.

film-coated tablets

1 film-coated tablet contains:

active substance:

 melatonin 3 mg;

Excipients:

 calcium hydrogen phosphate 112 mg,

3.5 mg pregelatinized corn starch,

magnesium stearate 1.5 mg,

microcrystalline cellulose 40 mg;

film coating composition:

 Opadry 85F48105 II White 5 mg, including:

polyvinyl alcohol 2,345 mg,

macrogol (polyethylene glycol 4000) 1.18 mg,

talc 0.87 mg,

titanium dioxide 0.605 mg.

adaptogenic agent.

For sleep disorders, including caused by a disturbance in the rhythm of "sleep-wakefulness", such as desynchronosis (a sharp change in time zones).

Hypersensitivity to the components of the drug, autoimmune diseases, liver failure, severe renal failure, children under 18 years of age.

Classification of the incidence of side effects according to the recommendations of the World Health Organization:

very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000) , very rarely (<1/10000), including individual messages; the frequency is unknown (according to available data, it is not possible to establish the frequency of occurrence).

Infectious and parasitic diseases:

rarely: herpes zoster.

Disorders from the blood and lymphatic system:

rarely: leukopenia, thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions.

Metabolic and nutritional disorders:

rarely: hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders:

infrequently: irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety;

rarely: mood changes, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, decreased mood, depression.

Disorders from the nervous system:

infrequently: migraine, headache, lethargy, psychomotor hyperactivity, dizziness, drowsiness;

rarely: fainting, memory impairment, impaired attention, delirium, restless legs syndrome, poor sleep quality, paresthesia.

Violations of the organ of vision:

rarely: decreased visual acuity, blurred vision, increased lacrimation.

Hearing disorders and labyrinth disorders:

rarely: vertigo, positional vertigo.

Disorders from the cardiovascular system:

infrequently: arterial hypertension;

rarely: angina pectoris, palpitations, hot flashes.

Violations of the gastrointestinal tract:

infrequently: abdominal pain, abdominal pain in the upper abdomen, dyspepsia, ulcerative stomatitis, dry mouth, nausea;

rarely: gastroesophageal disease, gastrointestinal disturbance or upset, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, bloating, hypersecretion of saliva, halitosis, abdominal discomfort, gastric dyskinesia, gastritis.

Violations of the liver and biliary tract:

infrequently: hyperbilirubinemia.

Violations of the skin and subcutaneous tissues:

infrequently: dermatitis, sweating at night, itching and generalized itching, rash, dry skin;

rarely: eczema, erythema, dermatitis of the hands, psoriasis, generalized rash, itchy rash, nail damage;

frequency unknown: Quincke's edema, swelling of the oral mucosa, swelling of the tongue.

Violations of the musculoskeletal and connective tissue:

infrequently: pain in the limbs;

rarely: arthritis, muscle spasm, neck pain, night cramps.

Violations of the kidneys and urinary tract:

infrequently: glucosuria, proteinuria;

rarely: polyuria, hematuria, nocturia.

Violations of the genitals and breast:

infrequently: menopausal symptoms;

rarely: priapism, prostatitis;

frequency unknown: galactorrhea.

General disorders and disorders at the injection site:

infrequently: asthenia, chest pain;

rarely: fatigue, pain, thirst.

Laboratory and instrumental data:

infrequently: deviation from the norm of laboratory parameters of liver function, weight gain;

rarely: increased activity of “liver” transaminases, a deviation from the norm of the content of electrolytes in the blood, a deviation from the norm of the results of laboratory tests.

Pharmacokinetic interaction

• It is known that at concentrations significantly higher than therapeutic, melatonin induces the CYP3A isoenzyme  in vitro . The clinical significance of this phenomenon is not fully understood. If signs of induction develop, consideration should be given to reducing the dose of the drugs used simultaneously. 
• At concentrations significantly higher than therapeutic, melatonin does not induce isoenzymes of the CYP1A group in vitro . Therefore, the interaction of melatonin with other drugs due to the effect of melatonin on isoenzymes of the CYP1A group is apparently insignificant.  
• Melatonin metabolism is mainly mediated by CYP1A isoenzymes. Therefore, the interaction of melatonin with other drugs is possible due to the effect of melatonin on isoenzymes of the CYP1A group.
• Caution should be exercised in patients taking fluvoxamine, which increases the concentration of melatonin (increase in AUC by 17 times and Cmax by 12 times) due to inhibition of its metabolism by isoenzymes of cytochrome P450 (CYP): CYP1A2 and CYP2C19. This combination should be avoided.
• Caution should be exercised in patients taking 5- and 8-methoxypsorolen, which increases the concentration of melatonin due to inhibition of its metabolism.
• Caution should be exercised in patients taking cimetidine (an inhibitor of CYP2D isoenzymes), since it increases the plasma melatonin content by inhibiting the latter.
• Smoking can reduce the concentration of melatonin due to the induction of the CYP1A2 isoenzyme.
• Caution should be exercised in relation to patients taking estrogens (for example, contraceptives or hormone replacement therapy) who increase the concentration of melatonin by inhibiting their metabolism by the isoenzymes CYP1A1 and CYP1A2.
• Inhibitors of CYPA2 isoenzymes, for example, quinolones, are able to increase the exposure of melatonin.
• Inducers of the CYP1A2 isoenzyme, such as carbamazepine and rifampicin, are able to lower the plasma concentration of melatonin.
• There is a wealth of evidence in the literature on the effects of adrenergic and opioid receptor agonists / antagonists, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan and alcohol on the secretion of endogenous melatonin. Studies of the mutual influence of these drugs on the dynamics or kinetics of melatonin have not been conducted.

  Pharmacodynamic interaction

• While taking melatonin, you should not drink alcohol, as it reduces the effectiveness of the drug.
• Melatonin potentiates the sedative effect of benzodiazepine and nonbenzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. In a clinical study, there were clear signs of a transient pharmacodynamic interaction between melatonin and zolpidem an hour after they were taken. The combined use can lead to a progressive disorder of attention, memory and coordination compared with zolpidem monotherapy.
• During the studies, melatonin was prescribed in conjunction with thioridazine and imipramine, drugs that affect the central nervous system. None of the cases revealed a clinically significant pharmacokinetic interaction. However, concomitant use with melatonin led to an increase in the feeling of calm and difficulties in performing certain tasks in comparison with imipramine monotherapy, as well as to an increase in the feeling of “clouding in the head” in comparison with thioridazine monotherapy.

Inside. In case of sleep disturbance, desynchronosis - 1 tablet once a day 30-40 minutes before bedtime.

When used as an adaptogen when changing time zones - 1 day before the flight and in the next 2-5 days - 1 tablet 30-40 minutes before bedtime.

The maximum daily dose is 6 mg.

Elderly patients

With age, there is a decrease in the metabolism of melatonin, which must be considered when choosing a dosage regimen for elderly patients. With this in mind, in elderly patients, it is possible to take the drug 60-90 minutes before bedtime.

Renal failure

The effect of varying degrees of renal failure on the pharmacokinetics of melatonin has not been studied, so melatonin should be used with caution in such patients. Patients with severe renal failure are not recommended.

According to available literature data, the use of melatonin in a daily dose of up to 300 mg did not cause clinically significant adverse reactions. Hyperemia, abdominal cramps, diarrhea, headache and scotoma were observed with the use of melatonin in doses of 3000 - 6600 mg for several weeks.

When using very high doses of melatonin (up to 1 g), involuntary loss of consciousness was observed. With an overdose, drowsiness may develop.

Treatment - gastric lavage and the use of activated charcoal, symptomatic therapy. The clearance of the active substance is expected within 12 hours after ingestion.

During the period of use of the drug Sonnovan®, it is recommended to avoid exposure to bright light.

It is necessary to inform women who want to become pregnant about the presence of a weak contraceptive effect in the drug.

There is no clinical data on the use of melatonin in patients with autoimmune diseases, and therefore, the use of this category of patients is not recommended.

Impact on the ability to drive vehicles and mechanisms

The drug Sonnovan® causes drowsiness, in connection with this, during the treatment period, you should refrain from driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.