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Introduction About ZOPITRAN 7.5MG TABLET

ZOPITRAN 7.5MG TABLET contains Zopiclone which belongs to the group of medicines known as Hypnotics and Sedatives. It is indicated for the short-term management and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and or early morning awakenings.

Insomnia is a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep. You may still feel tired when you wake up. It also affects your health, work performance and quality of life.

ZOPITRAN 7.5MG TABLET is not recommended for use in patients suffering from myasthenia gravis (muscle weakness), severe liver diseases, severe breathing problems, sleep apnoea (serious breathing problem while sleeping) and in patients who had stroke. Consult your doctor before taking.

ZOPITRAN 7.5MG TABLET should be used with caution in patients suffering from depression or any other mental illness, personality disorder, kidney disease, somnambulism (sleep walking), thyroid disorder, epilepsy (seizures). Consult your doctor before taking.

ZOPITRAN 7.5MG TABLET is not recommended for use in pregnant and breast-feeding women. Contact your doctor before taking.

ZOPITRAN 7.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking.

ZOPITRAN 7.5MG TABLET should be used with caution in elderly patients above age 65 years. Consult your doctor before taking.

The most common side effects of taking ZOPITRAN 7.5MG TABLET are dry mouth, bitter or metallic taste, feeling sleepy or drowsy, headache and fatigue, dizziness, lightheadedness and difficulty with coordination. Contact your doctor if you get any side effects. Specific serious side effects include suicidal thoughts in some patients. Consult your doctor immediately if you experience such thoughts.

Uses Of ZOPITRAN 7.5MG TABLET

Manage insomnia

How ZOPITRAN 7.5MG TABLET Works

ZOPITRAN 7.5MG TABLET helps to improve your sleep by binding to benzodiazepine receptors in brain and increases the level of a chemical in the brain called GABA (a neurotransmitter helps to transfer messages in the brain) and produces a calming effect on the brain. Thus, helps to manage sleep disorders.

How to use ZOPITRAN 7.5MG TABLET

Take ZOPITRAN 7.5MG TABLET as advised by your doctor. Do not crush or chew the medicine while consuming it with water. Your doctor will decide the correct dosage and duration for you depending upon your age, body weight and disease condition.

Side Effects Of ZOPITRAN 7.5MG TABLET

Common

dry mouth
metallic or bitter taste
feeling sleepy or drowsy
headache, fatigue
dizziness, lightheadedness
difficulty with coordination
falling (especially in elderly patients)

Uncommon

nausea, vomiting
diarrhoea, constipation
increased or loss of appetite
epigastric pain, indigestion, heart burn
weakness
confusion, depression
palpitations (especially in elderly patients)
amnesia (memory loss)
difficulty breathing
coated tongue or bad breath
severe itching, tingling sensation, rashes
reduced sexual drive, impotence, ejaculation failure
feeling of drunkenness
euphoria
hypotonia
speech disorder
tremor
rebound insomnia
muscle pain
rages
psychoses (mental illness)

Rare

itchy, lumpy rash (urticaria)

Stop taking ZOPITRAN 7.5MG TABLET and consult your doctor immediately in case you experience any of following:

severe allergic reaction such as rash, itching, breathing difficulty and swallowing, swelling in throat, tongue, lips, and face
fainting
sleepwalking or other unusual behaviour (such as driving, eating, making a phone call, or having sex) while not being fully awake
psychiatric and paradoxical reactions like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, inappropriate behaviour
suicidal thoughts or are experiencing changes in your behaviour
symptoms of withdrawal effects such as abdominal pain, muscle cramps, vomiting, sweating, tremor, and fits

How To Manage Side Effects

Headache:

Take rest and plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching screen for long time. Consult your doctor if the condition persists for long or gets worsened.

Dizziness:

Lie down until the dizziness passes and get up slowly. Do not bend down suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids. Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition persists for long or gets worsened.

Dry mouth:

Drinking water and staying hydrated can help relieve dry mouth. Chew sugar-free gum or suck on sugar-free hard candies to stimulate the flow of saliva. If this persists for a long time, consult your doctor.

Warning & Precautions

Pregnancy

ZOPITRAN 7.5MG TABLET is not recommended for use in pregnant women as it may cause harm to the unborn baby. Consult your doctor before taking.

Breastfeeding

ZOPITRAN 7.5MG TABLET is not recommended for use in breast feeding women as it may pass into the breast milk. Consult your doctor before taking.

Driving and Using Machines

ZOPITRAN 7.5MG TABLET may cause drowsiness which can affect your ability to drive and operate machines. Do not drive or operate machines after taking ZOPITRAN 7.5MG TABLET.

Alcohol

ZOPITRAN 7.5MG TABLET is not recommended for use in patients who have history of alcohol abuse. Consumption of alcohol is not advised while taking this medicine as it increases sleepiness. Consult your doctor before taking.

Kidney

ZOPITRAN 7.5MG TABLET should be used with caution in patients suffering from kidney disease. Consult your doctor before taking.

Liver

ZOPITRAN 7.5MG TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with mild to moderate liver diseases. Consult your doctor before taking.

Allergy

Do not take ZOPITRAN 7.5MG TABLET if you are allergic to Zopiclone or to other ingredients of medicine.

Lungs

ZOPITRAN 7.5MG TABLET is not recommended for use in patients suffering from sleep apnoea (severe breathing disorder in sleep) and in patients suffering from severe respiratory disorders. Consult your doctor before taking.

Others

ZOPITRAN 7.5MG TABLET is not recommended for use if you:

have myasthenia gravis (muscle weakness)
had stroke
ever experienced sleepwalking or other unusual behaviour while not being fully awake after taking ZOPITRAN 7.5MG TABLET

Before taking ZOPITRAN 7.5MG TABLET inform your doctor if you have:

personality disorder
depression and any other mental illness such as psychoses, schizophrenia
a history of drug abuse
periodic limb movement disorder (involuntary moving the limbs in sleep)
restless legs syndrome (an urge to move legs constantly)
surgery or anaesthesia
somnambulism (sleep walking)
thyroid disorder
epilepsy (seizures)

Use in paediatrics:

ZOPITRAN 7.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking.

Use in geriatrics:

ZOPITRAN 7.5MG TABLET should be used with caution in elderly patients as they are more susceptible to the sedative effects of this medicine associated with giddiness, ataxia and confusion, which may increase the possibility of a fall. Consult your doctor before taking.

Interactions

A. Drug-Drug interactions:

Before taking ZOPITRAN 7.5MG TABLET inform your doctor if you are taking any of the following medicine:

clozapine, haloperidol, chlorpromazine (medicines used for management of mental illness)
imipramine, moclobemide (medicines used for management of depression)
phenobarbital, phenytoin, carbamazepine, trimethadione (medicines used for management of epilepsy)
anaesthetics such as hexobarbital (medicines used during surgery)
medicines to calm or reduce anxiety or for sleep problems (hypnotics) ex. diazepam, alprazolam
St. John’s Wort (medicine used for depression and mood swings)
skeletal muscle relaxants Ex. baclofen (medicine used to relax muscles)
chlorphenamine, promethazine (medicines used for management for hay fever or allergies)
opioids such as codeine, methadone, tramadol, pethidine, oxycodone, morphine (medicines used as strong pain killers)
rifampicin (medicine used in management of tuberculosis)
ketoconazole, itraconazole (medicines used for management of fungal infections)
clarithromycin, erythromycin (medicines used for management of infections)
ritonavir (medicines used for HIV infection)

Overdosage:

If you or anybody else accidently takes too much ZOPITRAN 7.5MG TABLET, consult your nearest hospital immediately. Symptoms of mild overdosage are drowsiness, dizziness, lightheaded or faint, falling over or losing your balance, confusion, lethargy, sleeping deeply and possibly falling into a coma.

Symptoms of severe overdosage are low blood pressure, respiratory disorder or shallow breathing or difficulty breathing, weak muscle tone, methemoglobinemia (increased methaemoglobin in blood), ataxia (impaired coordination). Consult your doctor.

Synopsis

Drug	:	Zopiclone
Pharmacological Category	:	Hypnotic and Sedatives
Therapeutic Indication	:	Insomnia
Dosage Forms	:	Tablet

More Information

Keep ZOPITRAN 7.5MG TABLET out of reach of children
Store the medicine at room temperature below 25°C

FAQs About ZOPITRAN 7.5MG TABLET

Can i take alcohol with ZOPITRAN 7.5MG TABLET?

ZOPITRAN 7.5MG TABLET is not recommended for use in patient who have history of alcohol abuse. Consumption of alcohol is not advised while taking ZOPITRAN 7.5MG TABLET as it can increase sleepiness. Consult your doctor before taking.

Is ZOPITRAN 7.5MG TABLET safe in pregnancy?

ZOPITRAN 7.5MG TABLET is not recommended for use in pregnant women as it may cause harm to unborn baby. Consult your doctor before taking.

Which pain killers I should avoid while taking ZOPITRAN 7.5MG TABLET?

Strong painkillers such as codeine, methadone, tramadol, pethidine, oxycodone, morphine should be taken only after consultation from your doctor.

Is ZOPITRAN 7.5MG TABLET a strong sleeping Pill?

ZOPITRAN 7.5MG TABLET belongs to group of medicines called Hypnotics and Sedatives. It is used for short term management of sleep disorders such as insomnia. It helps you fall asleep more quickly and helps stop you waking up during the night. It helps you sleep by affecting a calming chemical in your brain called gamma-aminobutyric acid (GABA).

What are the side effects of taking ZOPITRAN 7.5MG TABLET?

The most common side effects of taking ZOPITRAN 7.5MG TABLET are dry mouth, bitter or metallic taste, feeling sleepy or drowsy, headache and fatigue, dizziness, difficulty coordination. Contact your doctor if you get any of the above side effects.

Does ZOPITRAN 7.5MG TABLET cause liver damage?

No, ZOPITRAN 7.5MG TABLET has not been reported to cause liver damage and rarely causes serum enzyme elevations. Contact your doctor before taking.

References

1. KD Tripathi. Drugs Acting on Central Nervous System. Essentials of pharmacology, 7th edition.2013 page 406.

2. Adoble, T Canton, C Malgouris, J Stutzmann, O Piot, M Bardone, C Pauchet, J Blanchard. The mechanism of action of Zopiclone. European Psychiatry. 1995. [Accessed on 27th August 2022] https://pubmed.ncbi.nlm.nih.gov/19698408/#:~:text=The%20mechanism%20of%20action%20of%20the%20cyclopyrrolone%20hypnotic%20drug%20zopiclone,%5B(35)S%5D%2DTBPS.

3. Accord. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 27th August 2022] https://www.medicines.org.uk/emc/files/pil.5894.pdf

4. Teva Pharma Limited. Zopiclone. [Revised in September 2017] [Accessed on 27th August 2022] https://www.medsafe.govt.nz/profs/datasheet/z/zopicloneactavistab.pdf

5. Sanofi-Aventis. Zopiclone. [Revised in September 2018] [Accessed on 27th August 2022] https://pdf.hres.ca/dpd_pm/00047617.PDF

6. Sanofi-Aventis. Zopiclone. [Revised in June 2022] [Accessed on 27th August 2022] https://www.medsafe.govt.nz/Consumers/cmi/i/imovane.pdf

Author Details

Written By Dr. Janet.C - Pharm.D

Reviewed For Accuracy By Dr. Aravindan Balachandran - MBBS, MD (Psychiatry)

Last updated on 26 Sep 2022 | 11:28 AM(IST)