Somnol
Somnol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Somnol
ATX code: N05CF01
Active ingredient: zopiclone (zopiclone)
Producer: Grindex JSC (Latvia)
Description and photo updated: 2019-27-08
Somnol is a hypnotic drug.
Release form and composition
The drug is available in the form of film-coated tablets: biconvex, round, white, on the one hand there is a risk; on the cut a white core (10 pieces in blisters, one or two packages in a cardboard box and instructions for use of Somnol).
Composition of 1 tablet:
- active substance: zopiclone - 7.5 mg;
- auxiliary components: dried potato starch, sodium carboxymethyl starch, anhydrous calcium hydrogen phosphate, silicon dioxide, magnesium stearate;
- film casing: White Opadry 33G28707 (macrogol 3000, triacetin, hypromellose, titanium dioxide, lactose monohydrate).
Pharmacological properties
Pharmacodynamics
The active substance of Somnol - zopiclone, is a derivative of cyclopirrolone. It has a hypnotic, sedative, anticonvulsant, muscle relaxant and tranquilizing effect. The mechanism of action is due to the ability of the drug to affect the receptors of the central nervous system, which belong to the macromolecular complex GABA, and modulate the opening of channels for chlorine ions.
Somnol helps to reduce the time to fall asleep, the frequency of night and early awakenings, increase the duration of sleep, improve the quality of sleep and awakening. These effects of zopiclone are combined with a characteristic electroencephalographic profile, which differs from that observed with benzodiazepines.
For insomnia, the drug shortens the first phase of sleep, prolongs the second phase, and also maintains or prolongs the stages of deep sleep (III and V) and rapid (paradoxical) sleep. After taking Somnol, falling asleep occurs within 30 minutes and sleep continues for 6-8 hours.
The use of the drug for 4 weeks does not cause the development of significant rebound insomnia. There is no decrease in the hypnotic effect when taking Somnol for a period of up to 17 weeks.
Pharmacokinetics
Once in the gastrointestinal tract, zopiclone is rapidly and completely absorbed. Maximum plasma concentrations are reached within 1.5–2 hours and are about 30 ng / ml and 60 ng / ml after taking doses of 3.75 and 7.5 mg, respectively. Food intake does not affect the absorption of Somnol.
Zopiclone weakly binds to plasma proteins (~ 45%). The likelihood of protein-binding interactions with other drugs is very low. The substance is rapidly distributed from the systemic circulation, the volume of distribution is 91.8-10.4 liters. It easily penetrates the blood-brain barrier, as well as into breast milk (the concentration in milk is about the same as in plasma), while no more than 1% of the dose received by the woman during the previous day enters the child's body.
Interindividual differences in the pharmacokinetic parameters of the drug are insignificant. Zopiclone and its metabolites do not cumulate.
The drug is metabolized in the liver to form two metabolites: a pharmacologically active N-oxide derivative and a pharmacologically inactive N-demethyl metabolite. The half-life of metabolites is 4.5 and 7.4 hours, respectively.
The half-life of unchanged zopiclone is approximately 5 hours. The clearance of the substance is predominantly metabolic, as indicated by the low values of the renal clearance of unchanged zopiclone (8.4 ml / min) compared to its plasma clearance (232 ml / min).
The drug is excreted: with urine, mainly in the form of metabolites - up to 80%, with feces - about 16%.
In elderly patients, there is a slight decrease in the metabolism of zopiclone in the liver and an increase in the half-life up to 7 hours, however, accumulation in plasma was not detected even with repeated administration of Somnol. Cumulation of the active substance and its metabolites was not detected during long-term treatment in patients with renal insufficiency.
With cirrhosis of the liver, the demethylation process decreases, therefore, the plasma clearance of zopiclone decreases by about 40%. In this connection, dose adjustment is required.
Indications for use
Somnol is used in adult patients to treat situational, chronic, and transient insomnia, including difficulty falling asleep and early and nocturnal awakenings.
Contraindications
Absolute:
- chronic and acute hepatic failure of severe degree;
- severe respiratory distress;
- sleep apnea syndrome;
- myasthenia gravis;
- lactase deficiency, glucose-galactose malabsorption syndrome, congenital galactose intolerance (the drug contains lactose);
- children and adolescents up to 18 years of age (the safety and efficacy of using Somnol in this category of patients have not been established);
- lactation period;
- hypersensitivity to the main or auxiliary components of the drug.
Relative (Somnol is used with caution):
- a history of drug, alcohol or drug dependence;
- impaired renal and / or liver function;
- simultaneous use with alcohol or other psychotropic drugs (due to an increased risk of abuse or dependence);
- advanced age over 65 years.
Somnol, instructions for use: method and dosage
Somnol tablets are intended for oral administration in the evening, just before going to bed.
The drug is recommended for short-term use, no more than 4 weeks, including the period of dose reduction. The decision to increase the duration of therapy beyond this period is taken only after re-evaluating the patient's condition.
Treatment begins with the lowest effective dose. It is forbidden to take Somnol in doses exceeding the maximum.
Adult patients aged 18–65 years are prescribed 1 tablet (7.5 mg) of Somnol once a day.
Standing / pathology, for which the recommended starting dose Somnola decrease to 1 / 2 tablets (3.75 mg) once daily:
- impaired renal function;
- dysfunction of the liver (in the future, it is possible to be careful, taking into account individual sensitivity, increasing the dose to 7.5 mg once a day);
- respiratory failure;
- age over 65 years (in the future, it is possible to be careful, taking into account individual sensitivity, increasing the dose to 7.5 mg once a day).
The maximum daily dose of Somnol is 7.5 mg.
In case of transient insomnia, the duration of the drug use is 2–5 days, in case of situational insomnia - 2–3 weeks, in chronic insomnia - it is determined individually after consulting a doctor.
Side effects
- digestive system: very often - a metallic or bitter taste in the mouth; possibly - dry mouth, nausea, dyspepsia, a slight increase in the activity of alkaline phosphatase and / or liver enzymes in the blood serum;
- nervous system: upon awakening, headache, drowsiness, depression, dizziness, anterograde amnesia, impaired coordination of movements, aggressiveness, euphoria are possible; paradoxical and mental reactions - confusion, confusion, nightmares, irritability, depressed mood, hallucinations, inappropriate behavior, impaired libido, sleepwalking (the listed adverse reactions are more often observed in older patients and are rarely severe);
- allergic reactions: skin rash, itching, angioedema and / or anaphylactic reactions.
When treatment with Somnol is discontinued, rebound insomnia may occur (increased or renewed insomnia, frequent awakenings) or drug dependence may develop, but these side effects appear only after prolonged use; in very rare cases, convulsions are possible.
If the duration of treatment is more than 4 weeks, with a sharp withdrawal of Somnol, a withdrawal syndrome may occur, which is manifested by the following symptoms: headache, anxiety, agitation, muscle pain, insomnia, irritability, tension, impaired consciousness. In severe cases, depersonalization, increased sensitivity to light, noise and physical contact, impaired perception of reality, epileptic seizures, limb numbness and loss of sensation, hallucinations may develop. If treatment with the drug has not exceeded 4 weeks, then the development of a withdrawal syndrome is unlikely.
Overdose
In case of an overdose, there is a depression of the central nervous system (CNS) of varying severity - from drowsiness to coma, which depends on the size of the dose of Somnol taken. In mild cases, drowsiness, apathy, and confusion occur. In more severe cases, hypotension, ataxia, respiratory depression, lethargy, coma are observed, in rare cases - atrioventricular block. These symptoms are usually not life threatening for the patient. However, with the simultaneous use of alcohol or other drugs with a depressing CNS effect, an overdose of Somnol can be severe and life-threatening. Associated risk factors, such as a weakened patient's condition or the presence of a medical condition, can aggravate the symptoms and in some cases even lead to death.
After taking an excessive dose of the drug, if no more than 1 hour has passed, gastric lavage and activated charcoal should be taken. With severe symptoms of central nervous system depression, flumazenil may be prescribed as an antidote. However, it is contraindicated to use it if an overdose of Somnol is combined with an overdose of other drugs, as well as as a diagnostic agent for an overdose of unknown drugs to establish or exclude a diagnosis of benzodiazepine intoxication. If required, in a hospital, symptomatic and supportive therapy is carried out under the control of vital body functions (cardiovascular and respiratory). Zopiclone has a large volume of distribution, so hemodialysis is ineffective.
special instructions
Before prescribing the drug Somnol, it is necessary to find out the cause of insomnia and eliminate possible factors that could cause such sleep disturbances.
Benzodiazepines and their analogs are not first line drugs for psychosis.
The risk of drug dependence or abuse is increased in the following cases:
- Increasing the dose of zopiclone and exceeding the recommended duration of therapy.
- Joint intake of sleeping pills with alcohol or other psychotropic substances.
- Excessive use of alcohol and / or other drugs simultaneously with zopiclone therapy.
- The presence of anxiety in the patient.
In order to avoid the withdrawal syndrome and the occurrence of rebound insomnia, Somnol is recommended to be canceled gradually, gradually reducing the dose and warning the patient about this.
To reduce the risk of developing anterograde amnesia, the drug should be taken immediately before bedtime, and the total duration of sleep should be at least 7-8 hours.
Somnol is not intended to treat depression; moreover, it may mask the symptoms of the disease. Therefore, in cases where insomnia is due to depression, it is preliminarily recommended to treat the underlying disease.
If paradoxical and mental reactions appear, Somnol therapy should be discontinued.
Influence on the ability to drive vehicles and complex mechanisms
The drug belongs to sedatives that cause drowsiness, therefore, after taking Somnol, you must refrain from driving a car or performing potentially dangerous activities associated with increased concentration.
Application during pregnancy and lactation
Due to the lack of clinical experience, Somnol is not recommended for use in the first trimester of pregnancy. If it is necessary to carry out therapy in the third trimester, if possible, prescribe the drug in the minimum effective dose, and also observe the condition of the newborn for the development of hypothermia, hypotension, drowsiness, respiratory depression and withdrawal symptoms.
Women of reproductive age, in case of suspicion or planned pregnancy, should contact their doctor.
Zopiclone penetrates into the mother's milk, therefore, it can cause sedation in the infant (decreased tone and weakness), in this regard, Somnol is contraindicated during lactation.
Pediatric use
The sleeping pill is not intended for use in children and adolescents (under 18 years of age).
With impaired renal function
The recommended starting dose for patients with impaired renal function is 3.75 mg.
For violations of liver function
For impaired liver function, the initial recommended dose is 3.75 mg. If necessary, it is further increased to 7.5 mg.
Somnol is contraindicated in patients with severe hepatic impairment.
Use in the elderly
Treatment of patients over the age of 65 begins with a daily dose of 3.75 mg. If the need arises, its increase is possible, provided that the drug is well tolerated.
Drug interactions
The drug is not recommended to be taken simultaneously with ethanol, as it enhances the sedative effect of zopiclone.
When Somnol tablets are used together with tranquilizers, antidepressants, anesthetics, narcotic analgesics, hypnotics, antipsychotics, sedatives, anticonvulsants, as well as blockers of histamine H 1 receptors with a sedative effect, an increase in the inhibitory effect on the central nervous system can be observed. Before taking Somnol and the listed medicines at the same time, it is recommended to evaluate the expected benefits and risks of the treatment.
When used together with narcotic analgesics (including opiates and morphine derivatives), euphoria may increase and the risk of drug dependence may increase.
With the simultaneous administration of Somnol: with trimipramine - the effectiveness of trimipramine decreases; with barbiturates and narcotic analgesics - respiratory depression is possible, and in case of an overdose, death; with clozapine - increases the risk of shock with cardiac and / or respiratory arrest.
Antifungal drugs, erythromycin and other inhibitors of hepatic enzymes enhance the effect of Somnol, while phenytoin, rifampicin and carbamazepine reduce its therapeutic effect.
Analogs
Somnol's analogues are Andante, Belsomra, Deksdor, Donormil, Dormikum, Zolpidem, Ivadal, Imovan, Midazolam, Nitrazepam, Nitrest, Oniria, Reladorm, Relaxon, Sanval, Thorson.
Terms and conditions of storage
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Somnol
Reviews about Somnol are mostly positive: the drug effectively helps to cope with insomnia.
In negative messages, patients write that this sleeping pill is highly addictive, which is very difficult to overcome. Experts, however, note that in order to avoid dependence when taking any such drugs, it is important to strictly adhere to all the doctor's recommendations and in no case do not increase the dose on your own.
Price for Somnol in pharmacies
The approximate price of Somnol is 172-199 rubles. per pack of 20 tablets.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
