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Somnol® (Zopiclone) 7.5 mg, 10 coated tablets

$18.20

Somnol® (Zopiclone) a sleeping tablet that is widely used to treat the short-term treatment of insomnia in adults. Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended. The approved adult dose is 7.5 mg taken shortly before bedtime for up to a maximum of 4 weeks.

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Description

Somnol® (Zopiclone) a sleeping tablet that is widely used to treat the short-term treatment of insomnia in adults. Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended. The approved adult dose is 7.5 mg taken shortly before bedtime for up to a maximum of 4 weeks.

Common brand names: Zimovane, Imovane, Zoclone, Zopiclone Actavis, Zopiclone Kent,, Apo-Zopiclone, Sandoz Zopiclone, PMS-Zopiclone, Zopiclone Sanis Health, Rhovane, RAN-Zopiclone, Zopiclone Mylan, Zopiclone Ranbaxy, Zopiclone Zydus

 


 

Composition

One tablet contains the active substance – zopiclone 7.5 mg,
excipients: calcium hydrogen phosphate, anhydrous, potato starch, magnesium stearate, sodium starch glycolate (type A), silicon dioxide

 

Indications for use

  • Transient, situational insomnia
  • Chronic insomnia (short-term treatment)

 

Method of administration and dosage

Somnol tablets 7.5 mg are administered orally.

Adults are prescribed 1 tablet shortly before going to bed.

The duration of continuous treatment is no more than 4 weeks.

Somnol is not prescribed for children and adolescents under the age of 18.

Patients with impaired renal function are recommended to begin treatment with a dose of 3.75 mg, although the cumulation of the drug in this group of patients was not observed.

Patients with impaired liver function are recommended to start treatment with a dose of 3.75 mg, since the elimination of the drug in this group of patients is reduced. If necessary, the dose can be carefully increased to 7.5 mg, taking into account the sensitivity of the patient.

Elderly patients are initially prescribed 3.75 mg of the drug. If necessary, the dose of the drug can be gradually increased, taking into account the individual sensitivity of the patient.

The maximum single and daily dose of somnol is 7.5 mg.

 

Side effects

Cases of withdrawal syndrome are known when Somnol® therapy is discontinued. Withdrawal symptoms vary and may include rebound insomnia, muscle pain, anxiety, tremors, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, irritability.

In severe cases, the following symptoms are possible: derealization, depersonalization, hyperacusis, numbness and tingling sensation in the extremities, hypersensitivity to light, noise and physical contact, hallucinations. In very rare cases, seizures are possible.

Often
dry mouth
– dysgeusia (bitter taste), residual drowsiness
Sometimes
– headache, dizziness
– nausea
– tiredness
– nightmares, agitation
Seldom
– anterograde amnesia
– rash, itching
– confusion, irritability, aggressiveness, hallucinations
– violation of libido
– fall (mainly in adult patients)
Rarely
– angioedema, anaphylactic reactions
– increased levels of transaminases and / or alkaline phosphatase in the blood (mild to moderate)
Frequency unknown
– dyspepsia
– diplopia
– anxiety, delirium, irritability, abnormal behavior for the patient (possibly associated with amnesia) and somnambulism, dependence, withdrawal syndrome
– ataxia
– muscle weakness

Contraindications

– hypersensitivity to the drug
– severe myasthenia gravis
– severe liver dysfunction
– severe sleep apnea
– respiratory failure
– congenital galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
– pregnancy and lactation
– children and adolescents up to 18 years old

 

Drug interactions

Combinations not recommended

Alcohol

The sedative effect of benzodiazepines and related drugs is enhanced by alcohol. Driving or operating machinery can become hazardous if vigilance is reduced.

Patients should avoid taking alcoholic beverages and medicines containing alcohol.

Combinations requiring precautions for use

Rifampicin

Decreased plasma concentrations and decreased efficacy of zopiclone due to increased liver metabolism. Clinical monitoring. If necessary, you can use another sleeping aid.

Combinations to be taken into account

– Other central nervous system depressants

Morphine derivatives (analgesics, antitussives and substitution therapy, except buprenorphine), antipsychotics, barbiturates, sedatives, anxiolytics, other hypnotics, sedatives antidepressants, sedatives H1-antihistamines, antihypertensive drugs of central action, bacteriophene, thalifen, thalifen Central nervous system (CNS) suppression increases. Reduced vigilance can make driving or operating machinery dangerous.

Moreover, with the simultaneous use of zopiclone with morphine derivatives (analgesics, antitussives and replacement therapy) and barbiturates, the risk of respiratory depression increases, which in case of an overdose can be fatal.

Buprenorphine

When used as replacement therapy, the risk of lethal respiratory depression increases. The balance of benefits and harms of this combination should be carefully weighed. The patient must be warned about the need to strictly observe the prescribed dose.

Clozapine

Increased risk of acute vascular insufficiency with respiratory and / or cardiac arrest.

– Clarithromycin, ketoconazole, itraconazole, voriconazole, nelfinavir, ritonavir

Slightly increased sedative effect of zopiclone.

 

Special instructions

Drug addiction

Taking sedatives/sleeping drugs such as zopiclone can lead to physical and mental drug dependence or abuse.

The risk of addiction or abuse is increased:

– with the dose and duration of treatment

– if you have a history of alcohol and/or drug abuse

– when taken with alcohol or other psychotropic drugs.

Sudden discontinuation of treatment when physical dependence develops may be accompanied by withdrawal symptoms.

Ricochet insomnia

A transient syndrome in which the symptoms for which sedatives / hypnotics have been prescribed may return in an intensified form when the latter is canceled.

Since the risk of this phenomenon is higher after stopping treatment with Somnol®, especially after prolonged therapy, it is recommended to gradually reduce the dosage and inform the patient accordingly.

Tolerance

After taking repeated doses, a decrease in the effectiveness of other sleeping pills may develop. However, there is no marked tolerance in patients treated for up to 4 weeks.

Amnesia

Anterograde amnesia may occur, especially after interrupted sleep or if sleep is delayed after taking the pill. To reduce this risk, patients should:

– take a pill just before bedtime, that is, in bed

– to take care of the conditions most conducive to a good night’s sleep.

Other psychiatric and paradoxical reactions

Cases of other psychiatric and paradoxical reactions are known, such as anxiety, agitation, irritability, aggression, delirium, irritation, nightmares, hallucinations, abnormal behavior for the patient, and other adverse behavioral effects that have arisen when taking sedatives / hypnotics such as zopiclone. If such reactions occur, zopiclone should be discontinued. Such reactions are more common in adults.

Sleepwalking and associated behavior

Sleepwalking and other associated behaviors, such as drowsy driving, cooking and eating, or making phone calls with amnesia after the event, have been reported in patients treated with zopiclone who were not fully awakened after taking it.

Concomitant use of alcohol and other CNS depressants with zopiclone increases the risk of this behavior in the same way as taking zopiclone in doses exceeding the maximum recommended dose. It is strongly recommended to consider the issue of abolishing zopiclone for patients with similar disorders.

Depression

Like other hypnotics, Somnol® is not part of the therapy for depression and can mask its symptoms.

The shell of somnol tablets contains a dye that contains lactose, so patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not be prescribed this drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery.

Since somnol belongs to the group of sedatives that cause drowsiness, after taking the drug, you cannot drive vehicles or perform the work of an operator of various devices and mechanisms.

 

Overdose

Symptoms: depression of the central nervous system, in which there is a complex of symptoms from drowsiness to coma. Usually, this depression of the central nervous system does not threaten the patient’s life. However, with the combined use of somnol with drugs that have a depressing effect on the central nervous system, an overdose can be severe and life-threatening for the patient.

Treatment: symptomatic treatment, focusing on the normalization of breathing and heart activity. The benzodiazepine receptor antagonist flumazenil can be used as an antidote. If the diagnosis of an overdose is established soon after taking the drug, it is advisable to perform gastric lavage. In case of an overdose of somnol, the use of hemodialysis does not give a therapeutic effect.

 

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children!

Shelf life – 3 years
Do not use after the expiration date printed on the package.

Additional information

Ingredient

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