Belsomra (Belsomra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSuvorexantSuvorexant
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  • Belsomra
    pills inwards 
    MSD FARMASYUTIKALS, LLC     Russia
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    Dosage of 10 mg

    Active substance: suvorexant 10.00 mg.

    Excipients: copovidone 40.00 mg, lactose monohydrate 20.94 mg, cellulose microcrystalline 41.25 mg, croscarmellose sodium 12.50 mg, magnesium stearate 0.313 mg.

    Film Sheath: Opadry II Green 39K110000 (5.6 mg) contains lactose monohydrate 35.0%, hypromellose-2910 33.0%, titanium dioxide 23.58%, triacetin 8.0%, dye diamond blue aluminum varnish 0.23%, iron oxide yellow 0.19%.

    Dosage of 15 mg

    Active substance: suvorexant 15.00 mg.

    Excipients: copovidone 60.00 mg, lactose monohydrate 31.41 mg, cellulose microcrystalline 61.88 mg, croscarmellose sodium 18.75 mg, magnesium stearate 0.469 mg.

    Film Sheath: Opadry II white 39K18561 (8.0 mg) contains lactose monohydrate 35.0%, hypromellose-2910 33.0%, titanium dioxide 24.0%, triacetin 8.0%.

    Dosage of 20 mg

    Active substance: suvorexant 20.00 mg.

    Excipients: copovidone 80.00 mg, lactose monohydrate 41.88 mg, cellulose microcrystalline 82.50 mg, croscarmellose sodium 25.00 mg, magnesium stearate 0.625 mg.

    Film Sheath: Opadry II white 39K18561 (8.8 mg) contains lactose monohydrate 35.0%, hypromellose-2910 33.0%, titanium dioxide 24.0%, triacetin 8.0%.

    Description:

    Dosage of 10 mg: round, biconvex tablets, film-coated light green color, engraved "33" on one side, smooth on the other side.

    Dosage of 15 mg: oval, biconvex tablets, film-coated white, with the company logo on one side and engraved "325" on the other side.

    Dosage of 20 mg: round, biconvex tablets, coated with a white film shell, with an engraving "335" and a company logo on one side, smooth on the other side.

    Pharmacotherapeutic group:Sleeping Pills
    ATX: & nbsp

    N.05.C   Sleeping and sedatives

    Pharmacodynamics:

    Mechanism of action

    Suvorexant is a highly selective, highly affinity antagonist of orexin O receptorsX1R (Ki 0.55 nmol / L) and OX2R (TOi 0.35 nmol / l).

    Orexin neuropeptide signaling system is the main mechanism providing the state of wakefulness. Nerve cells that produce orexin are located in the hypothalamus and affect the brain neurons responsible for the wakefulness process. Suvorexant triggers the physiological process of the transition of the brain from the state of waking to sleep by reversibly blocking the binding of wake neuropeptides (orexins A and B) to OX1 receptorsR and OX2R, thereby suppressing the maintenance of wakefulness.

    Suvorexant does not have direct pharmacological activity or the ability to bind (Ki > 10 μmol / L) with gamma-aminobutyric acid (GABA) receptors, serotonin, dopamine, noradrenaline, melatonin, histamine, acetylcholine, or opioid receptors.

    Effect of Belsomr's preparation on QTc interval

    The influence of suvorexant on QTc the interval was evaluated in a randomized placebo-and actively-controlled (with moxifloxacin 400 mg) cross-over study involving healthy volunteers (n = 53). An analysis of the study of suvorexant intake in doses up to 240 mg showed that the upper limit of the one-sided 95% confidence interval for the largest adjusted for placebo and the initial value interval QTc was less than 10 ms. In this way, suvorecant does not extend the interval QTc in any significant quantities.

    Pharmacokinetics:

    In the dose range of 10 mg to 80 mg, exposure to suvorexant increasescI do not ctrough dose-proportional to the decrease in absorption. Pharmacokinetic parameters of suvorexant in healthy volunteers and patients with insomnia are the same.

    Suction

    The maximum concentration of suvorexant is achieved on average after 2 hours (in the range from 30 minutes to 6 hours) when the drug is administered on an empty stomach. The average absolute bioavailability of suvorexant in a dose of 20 mg is 62% (5-95 percentile: 55% to 69%).

    The intake of suvorexant concomitantly with fatty foods led to a slight change in the area under the concentration-time curve (AUC) or maximum concentration (CmOh) and increasing the value tmax for about 1.5 hours. Suvorexant can be taken regardless of food intake. However, to achieve a more rapid effect of the onset of sleep suvorecant should not be taken during or immediately after meals.

    Distribution

    The average volume of distribution of suvorexant is approximately 49 liters. Suvorexant actively binds (> 99%) to human plasma proteins and practically does not penetrate into the red blood cells. Suvorexant binds to human serum albumin and α1-acid of the glycoprotein.

    Metabolism

    Suvorexant is excreted from the body mainly by metabolism, primarily with the help of isoenzyme CYP3A with insignificant participation of isoenzyme CYP2C19. The main circulating substances are suvorecant and a metabolite of hydroxy-suvorexant.It is not assumed that the metabolite is a pharmacologically active substance.

    Excretion

    The main way of removing suvorexant through the intestine: about 66% The radioactively measured dose was excreted by the intestine and 23% was excreted by the kidneys. Suvorexant is excreted from the body mainly in the form of metabolites, while in the form of unchanged suvorexant in faeces and urine, less than 1% of the administered dose was detected.

    With the dosing regimen once a day, the systemic pharmacokinetics of suvorexant is linear with a dose cumulation not exceeding twofold.

    The equilibrium state after taking the suvorexant once a day is achieved through 3 days and corresponds to the average value of t1/2 about 12 hours (95% CI: 12 to 13).

    Special patient groups

    The effect of impaired renal and hepatic function on the pharmacokinetic parameters of suvorexant was studied in special studies of pharmacokinetics.

    Patients with impaired renal function

    The exposure of suvorexant (expressed in concentrations of total and unrelated suvorexant) was the same in patients with impaired renal function of a serious degree (renal clearance of creatinine ≤30 mL / min / 1.73 m2) and in healthy volunteers.Correction of the dose in patients with impaired renal function is not required.

    Patients with impaired hepatic function

    The exposure of suvorexant after single dose was the same in patients with impaired liver function of moderate severity (7-9 on the Child-Pugh scale) and in healthy volunteers. However, the apparent final half-life of suvorexant increased from about 15 hours (range 10-22 hours) in healthy volunteers to 19 hours (range 11-49 hours) in patients with impaired liver function of moderate severity. Correction of the dose in patients with impaired liver function of mild and moderate severity is not required.

    The pharmacokinetic parameters of suvorexant have not been evaluated in volunteers with severe hepatic dysfunction (10-15 points on the Child-Pugh scale), therefore, the use of the drug is not recommended for this group of patients (see the sections "Contraindications" and "Special instructions").

    Age, sex, body mass index (BMI) and race

    Age, sex, BMI, and race were included in the population pharmacokinetic model as factors that allow the determination of pharmacokinetic parameters in healthy volunteers and predict the exposure in the patient population. The influence of sex, BMI and race did not lead to clinically significant changes in the pharmacokinetic parameters of suvorexant.

    The analysis of pharmacokinetic parameters in healthy volunteers and patients, both young (<65 years) and elderly (≥65 years), shows that the exposure of suvorexant was comparable in the elderly after taking the drug at a dose of 15 mg and in young people after taking the drug in a dose 20 mg (see the section "Dosing and Administration" and "Special instructions").

    After taking the drug Belsomra in a dose of 40 mg value AUC and FROMmax suvorexant in women is higher than in men, by 17% and 9%, respectively. The average concentration of suvorexant 9 hours after taking the dose is 5% higher in women in the range of doses studied (10-40 mg). Correction of the dose of the drug Belsomr, depending on gender, is not required.

    The apparent overall clearance of suvorexant is inversely proportional to BMI. In patients with obesity values AUC and CmOh higher by 31% and 17% respectively, compared with those in patients without obesity. The average concentration of suvorexant about 9 hours after taking 20 mg is 15% higher in obese patients (BMI> 30 kg / m2) in relation to that in patients with normal BMI (BMI ≤25 kg / m2). Correction of the dose of the drug Belsomra depending on the BMI is not required.

    Indications:

    The drug Belsomra is indicated for the treatment of insomnia, characterized by difficulty in falling asleep and / or maintaining sleep.

    Contraindications:

    - Known hypersensitivity to suvoreksantu or any other component of the drug (including in the anamnesis);

    - impaired hepatic function;

    - narcolepsy and cataplexy;

    - simultaneous use of Belsomra with strong inhibitors isoenzyme CYP3A (such as ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan);

    - simultaneous use of the drug Belsomra with other medicinal drugs used to treat insomnia;

    - pregnancy;

    - the period of breastfeeding;

    - children under 18 years of age (efficacy and safety not studied).

    The drug Belsomra contains lactose, so patients with rare hereditary lactose intolerance, lactase deficiency or impaired glucose-galactose absorption should not take this drug.

    Carefully:

    - Addiction or abuse of medicines (or narcotic drugs) drugs) or alcohol in history;

    - disturbances in the function of respiration, including obstructive sleep apnea, chronic obstructive pulmonary disease.

    Pregnancy and lactation:

    The use of Belsomr during pregnancy and during breastfeeding is contraindicated.

    Clinical studies on the use of the drug Belsomra in pregnant women have not been conducted.

    In two separate studies, oral administration of suvorexant at doses of 30, 150 and 1000 mg / kg or 30. 80 and 325 mg / kg to pregnant female rats during organogenesis resulted in a decrease in fetal body weight when taking a dose of more than 80 mg / kg. Plasma exposures (AUC) when taking a dose that does not lead to an effect, exceeded the exposure achieved in a person with a maximum recommended dose (MPD) of 20 mg / day, about 25 times. In two separate studies, oral administration of suvorexant at doses of 40, 100 and 300 mg / kg or 50, 150 and 325 mg / kg to pregnant female rabbits during organogenesis did not result in visible undesirable phenomena in embryo-fetal development. The increased toxicity when taking a dose of 325 mg / kg led to the premature euthanasia of pregnant female animals. At the highest values ​​of maternal exposure (AUC) the values ​​of this parameter in the fetus exceeded the exposure achieved in humans when taking MPD, about 40 times. The use of suvorexant (orally at doses of 30, 80 and 200 mg / kg) in pregnant female rats during gestation and lactation resulted in a decrease in the body weight of the offspring when the highest test dose was taken. Plasma AUC when taking a dose that did not lead to an effect, exceeded the exposure achieved in humans when taking MPD, approximately 25 times.

    There is no data on the isolation of suvorexant in human milk, however suvorecant and its metabolite hydroxy-suvorexant were released into the milk of rats at concentrations higher than those in the plasma of the parent (9 and 1.5 times, respectively).

    Dosing and Administration:

    For oral administration.

    Adult patients (before the age of 65 and after age 65)

    The recommended dose for patients under the age of 65 is 20 mg, for patients over the age of 65, 15 mg. The recommended dose should be taken no more often than 1 time per night, within 30 minutes before bedtime and not later than 7 hours before the expected time of awakening.

    Simultaneous use with moderate inhibitors of isoenzyme CYP3A

    The recommended dose of Belsomr's drug when used concomitantly with moderate isoenzyme inhibitors CYP3A is 10 mg. The recommended dose should not be exceeded (see section "Interaction with other drugs").

    Effect of food on the effect of the drug

    When taking the drug Belsomr during or immediately after eating the effect of the drug may occur later.

    Side effects:

    Because clinical trials are conducted under substantially different conditions, the incidence of adverse reactions observed in clinical trials of the drug can not be exactly comparable with the incidence of adverse drug reactions in clinical trials of other drugs and may not correspond to the frequency of adverse reactions observed with the drug in clinical use practice.

    1263 adult patients participated in controlled studies on the efficacy of the drug for 3 months, including 493 patients who received the drug Belsomr at doses of 15 mg and 20 mg.

    In long-term studies, an additional number of patients (n = 521) received treatment with Belsomra in doses exceeding the recommended levels, including 160 patients who received Belsomr for at least 1 year.

    The combined safety data described in Table 1 reflect the profile of adverse reactions detected during the first 3 months of treatment.

    Undesirable reactions, leading to cancellation of treatment

    The frequency of cessation of treatment due to the development of adverse reactions in the group of patients taking the drug Belsomr at doses of 15 mg and 20 mg and in the group of patients taking placebo was 3% and 5%, respectively. No individual adverse reaction resulted in the cessation of treatment with a frequency of ≥1%.

    Undesirable reactions, Identified in placebo-controlled clinical trials

    In clinical studies in patients with insomnia who took the drug Belsomra doses of 15 or 20 mg, the most frequent adverse reaction (reported at a frequency of 5% or more in patients receiving the Belsomr drug, and at least 2 times more often than in the placebo group) was drowsiness (7% for the drug Belsomra, 3% for placebo). When taking Belsomra in doses of 15 or 20 mg, the incidence of drowsiness was higher in women (8%) than in men (3%).

    Table 1 shows the number of patients in% with adverse reactions,revealed during the first three months of treatment, according to the combined data of controlled studies on the effectiveness of the drug duration 3 month.

    The profile of adverse reactions in elderly patients was largely comparable to the profile of adverse reactions in younger patients. The adverse reactions reported during long-term treatment for 1 year were basically those observed during the first 3 months of treatment.

    Table 1. Number of patients in% with undesirable reactions, whose incidence ≥2% compared with the placebo group, revealed in controlled studies on the effectiveness of the drug lasting 3 months.

    Placebo

    Preparation Belsomra (in a dose 20 mg in young patients and 15 mg in elderly patients)


    n = 767

    n = 493

    From the gastrointestinal tract



    Diarrhea

    1

    2

    Dry mouth

    1

    2

    Infectious and parasitic diseases



    Upper respiratory tract infections

    1

    2

    From the nervous system



    Headache

    6

    7

    Drowsiness

    3

    7

    Dizziness

    2

    3

    Disorders of the psyche



    Unusual dreams

    1

    2

    On the part of the respiratory system, the organs of the thorax and the mediastinum



    Cough

    1

    2

    In clinical studies, cases of development of carotid paralysis and hypnagogic / hypnopomatic hallucinations were reported in patients taking Belsomr's preparation (<1%).

    Laboratory indicators

    In placebo-controlled clinical trials involving patients with insomnia, clinically significant differences in biochemical and general blood counts, as well as in the general urinalysis in the group of patients taking the Belsomr drug, and in the placebo group were not identified.

    Undesirable reactions identified in the post-marketing period of drug use

    The following undesirable reactions were identified during the post-marketing application of the Belsomr drug. Since reports of these undesirable reactions are obtained spontaneously from a population of undetermined size, it is not always possible to reliably estimate the frequency of the reactions and establish a cause-and-effect relationship with the effect of the drug.

    Disorders of the psyche: nightmares.

    Overdose:

    There are limited data on the pre-registration clinical experience of the effect of an overdose of Belsomr's drug.In the course of pharmacological clinical studies, healthy volunteers took doses up to 240 mg of suvorexant in the morning, with a dose-related increase in the incidence and duration of drowsiness. In case of an overdose, general symptomatic and maintenance therapy should be carried out, and if necessary, gastric lavage should be performed immediately. If necessary, intravenous solutions (eg, 0.9% sodium chloride solution, Ringer's solution) should be administered. As in all cases of drug overdose, it is necessary to control breathing, pulse, blood pressure and other relevant indicators of the body's condition and conduct general supportive therapy. The value of dialysis for overdose is not determined. Because the suvorecant actively binds to proteins, it is not expected that hemodialysis will contribute to the removal of suvorexant.

    As in all cases of drug overdose, one should consider the possibility of taking several medications simultaneously.

    Interaction:

    Substances depressing the central nervous system

    With the simultaneous use of Belsomr's drug with alcohol,psychomotor disorders. No changes in the pharmacokinetic parameters of these substances were detected (see section "Special instructions").

    With the simultaneous use of the drug Belsomra with paroxetine, there was no clinically significant pharmacokinetic or pharmacodynamic interaction (see section "Special instructions").

    The effect of other drugs on the action of suvorexant

    The main way to remove suvorexant is metabolism under the influence of isoenzyme CYP3A.

    Inhibitor inhibitors CYP3A

    Simultaneous use of suvorexant with ketoconazole (a strong inhibitor of isoenzyme CYP3A) significantly increased (in 2.79 times) the exposure of the suvorexant.

    Simultaneous use of Belsomr's preparation with strong inhibitors of isoenzyme CYP3A (such as ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended (see the sections "Contraindications" and "Special instructions").

    Simultaneous application of suvorexant with diltiazem (moderate inhibitor of isoenzyme CYP3A) increased (in 2.05 times) the exposure of the suvorexant.

    The recommended dose of Belsomra is 10 mg, while it is used with moderate isoenzyme inhibitors CYP3A (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, cryotinib, imatinib and verapamil) should not be exceeded (see section "Method of administration and dose").

    Inductors of isoenzyme CYP3A

    The exposure of the suvorexant can be significantly reduced when used simultaneously with strong isoenzyme inducers CYP3A (such as rifampicin, carbamazepine and phenytoin). Perhaps reducing the effectiveness of suvoreksanta.

    Effect of suvorexant on other drugs

    With a consistent multiple use suvorecant is a weak isoenzyme inhibitor CYP3A and intestinal p-glycoprotein.

    Midazolam

    Simultaneous application of suvorexant with midazolam (sensitive substrate isoenzyme CYP3A) slightly increased the exposure of midazolam. As with most drugs metabolized by the CYP3A isoenzyme, it is not expected that the use of suvorexant can lead to an increase in plasma concentrations to clinically significant values.

    Digoxin

    Simultaneous use of suvorexant with digoxin slightly increased the concentration of digoxin due to inhibition of intestinal p-glycoprotein. In the case of simultaneous use of the drug Belsomra with digoxin should monitor the concentration of digoxin according to clinical indications.

    Other concomitant therapy

    No clinically significant pharmacokinetic interactions were observed with the simultaneous use of suvorexant with warfarin or oral contraceptives.

    Special instructions:

    Patients with narcolepsy and cataplexy

    Since the study of the drug Belsomra in patients with narcolepsy and cataplexy was not performed, treatment of this group of patients with the drug is not recommended.

    Action on the central nervous system (CNS)

    Belsomr's drug is an agent that depresses the central nervous system, and can disrupt wakefulness during the day, even if the prescribed mode of administration is observed. The doctor prescribing treatment with the drug should control the appearance of drowsiness and symptoms of CNS depression in the patient.

    Taking Belsomra's drug may adversely affect the ability to drive vehicles and can increase the risk of falling asleep during vehicle management. After taking Belsomr's drug, patients should avoid hazardous activities such as driving or other dangerous mechanisms. In addition, the patient should be warned about a possible deterioration in performance the next day after taking the drug.

    The patient should be warned about refraining from drinking alcohol concomitantly with Belsomr's drug due to increased CNS depression (see section "Interaction with Other Drugs").

    Simultaneous use of the drug Belsomr with other means, depressing the central nervous system (eg, benzodiazepines, opioids, tricyclic antidepressants), increases the risk of CNS depression.

    The risk of emergence of the next day's impairment, including impairment of the ability to drive vehicles, is increased if, from the time of taking Belsomr's drug before awakening, there is time insufficient for proper sleep, and also when taking a dose exceeding the recommended dose,while taking the drug with other drugs that depress the central nervous system (for example, benzodiazepines, opioids, tricyclic antidepressants), or while taking the drug with drugs that increase the concentration of the drug Belsomr in the blood.

    The use of Belsomr along with other medications used to treat insomnia is not recommended.

    Patients with concomitant diseases

    Since sleep disorders can be a manifestation of physical and / or mental disorders, the treatment of insomnia should begin only after a thorough examination of the patient.

    Ineffective therapy for 7-10 days may indicate the presence of primary psychiatric and / or other diseases requiring diagnosis.

    An increase in insomnia or the appearance of new cognitive or behavioral disorders can be the result not of insomnia, but not of a diagnosed underlying mental or physical disorder, and may manifest itself during a course of treatment with sleeping pills such as Belsomra.

    Patients with pathological thinking and behavioral disorders

    Various cognitive and behavioral disorders (eg, amnesia, anxiety, hallucinations and other psychoneurological symptoms) associated with the use of drugs with hypnotics like Belsomr's preparation have been reported. There have been reports of episodes of unconscious complex behavior, such as "driving in a dream" (ie driving in a state of incomplete awakening after taking a hypnotic) or other episodes of unconscious complex behavior (somnambulism, cooking and eating in a dream), Amnesia events associated with the use of drugs with hypnotics. These reactions can occur both in patients who have not previously taken drugs with hypnotics, and in patients who have previously taken such drugs. The use of alcohol and other drugs that depress the central nervous system can increase the risk of such behavior. It is necessary to stop using Belsomra in patients who report cases of unconscious complex episodes (see "Interaction with other drugs").

    Patients with depression / suicidal thinking

    Reported worsening of the course of depression, including the development of suicidal thoughts and actions (including completed suicides) in patients with primary depression, taking drugs with hypnotics. When any new behavioral signs or symptoms of depression appear, a thorough and immediate assessment of the patient's condition is required.

    Patients with respiratory failure

    The effect of the Belsomr drug on respiratory function should be considered when administering the drug to patients with impaired breathing function. Care should be taken when prescribing Belsomr's drug to patients with impaired breathing.

    Obstructive sleep apnea

    The inhibitory effect of the Belsomr drug on respiratory function was studied in a randomized, placebo-controlled, cross-over study with two periods in patientsn = 26) with obstructive sleep apnea (OSA) of mild and moderate severity after one and after four consecutive nights of drug treatment. When taking the drug at a dose of 40 mg once a day, the average value of the apnea-hypopnea index with the difference in treatment methods (suvorecant - placebo) for the 4th day of treatment was 2.7 (90% CI: 0.22 to 5.09). Clinically significant effect of the drug Belsomr on respiratory function in patients with OSA can not be ruled out. The study of the drug Belsomra in patients with OSA severe degree was not conducted.

    Chronic obstructive pulmonary disease

    The inhibitory effect of the Belsomr drug on respiratory function was studied in a randomized, placebo-controlled, cross-over study with two periods in patientsn = 25) with chronic obstructive pulmonary disease (COPD) of mild and moderate severity after one and after four consecutive nights of drug treatment. The drug Belsomra (in young patients at a dose of 40 mg, in elderly patients at a dose of 30 mg) did not exert a depressant effect on respiratory function in patients with COPD of mild and moderate severity (determined by oxygen saturation). Clinically significant effect of Belsomr's drug on respiratory function in patients with COPD can not be excluded. A study of the Belsomr drug in severe COPD patients was not conducted.

    Strong inhibitors of the isoenzyme CYP3A

    Simultaneous use of Belsomr's preparation with strong inhibitors of isoenzyme CYP3A not recommended (see the sections "Contraindications" and "Interaction with other medicines").

    Patients with impaired hepatic function

    The pharmacokinetic parameters of suvorexant were similar in patients with a violation of liver function of moderate severity and in healthy volunteers. Correction of the dose in patients with impaired liver function of mild and moderate severity is not required. The study of the drug Belsomra in patients with impaired hepatic function was not carried out, therefore, the use of the drug in this group of patients is not recommended (see the section "Contraindications").

    Patients with impaired renal function

    The pharmacokinetic parameters of suvorexant were similar in patients with a violation of the function of the kidneys of a serious degree and in healthy volunteers. Correction of the dose in patients with impaired renal function is not required.

    Children

    Studies to study the safety and efficacy of using Belsomr in children have not been carried out, therefore, treatment with a drug for children under 18 years is not recommended (see "Contraindications").

    Elderly patients

    In clinical studies examining the safety and efficacy of the Phase III preparation of Belsomr (n= 1784), 829 patients aged 65 years and over and 159 patients aged 75 years and older participated. Clinically significant differences in the safety or efficacy of the drug were not observed in the group of patients of the indicated age and in the group of younger patients when taking the drug at the recommended doses. However, the sensitivity of some elderly patients can not be ruled out (see the section "Dosing and Administration").

    Abuse

    In a study of potential abuse in a group of recreational consumers of combinations of psychoactive substances (n = 36), suvsxang (in doses of 40, 80 and 150 mg) showed a similar effect to zolpidem (in doses of 15, 30 mg) on ​​the subjective assessment of "drug addiction".

    As with other drugs with hypnotics, due to the risk of misuse or abuse, care should be taken when prescribing Belsomr's drug to patients with a history of addiction or abuse of medicines (or narcotic drugs) or alcohol.

    Addiction

    In completed clinical trials of Belsomr's drug, no symptoms of physical dependence were observed with prolonged use of the drug. In addition, there were no signs of withdrawal syndrome after discontinuation of Belsomr's drug.

    Effect on the ability to drive transp. cf. and fur:

    The administration of Belsomra may adversely affect the ability to drive vehicles and work with machinery, and may increase the risk of falling asleep during vehicle management. After taking the drug, patients should avoid hazardous activities such as driving or other dangerous mechanisms. In addition, the patient should be warned about a possible deterioration in performance the next day after taking the drug Belsomr.

    Form release / dosage:Tablets, film-coated, 10 mg, 15 mg and 20 mg.
    Packaging:

    For 10 tablets in a blister of PVC / Al / PA and aluminum foil.

    For 1 or 3 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store in the original packaging, in a dry, protected from light place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004058
    Date of registration:29.12.2016
    Expiration Date:29.12.2021
    The owner of the registration certificate:MSD FARMASYUTIKALS, LLC MSD FARMASYUTIKALS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp28.01.2017
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