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Zopisign 10 Mg (Zopiclone)

Medically reviewed by Sanjay Gangani, B.Pharm, CMO & Pharmacist

Active Ingredient Zopiclone
Indication Anxiety and Insomnia
Manufacturer HAB Pharmaceuticals & Research Ltd
Strength:- 10mg
Packaging 14 Tablets in a strip

What is Zopisign 10 mg?

How Zopisign 10 mg Works (Mechanism of Action)

The action happens in five simple steps:

What that means for sleep:

Key pharmacology facts:

Why a higher dose is not simply better:

Dosage Guide

The table below shows licensed zopiclone dosing for insomnia.

Patient SituationLicensed Zopiclone DoseTimingMaximum Duration
Adults, recommended dose7.5 mgShortly before going to bedFour weeks including tapering
Zopisign 10 mg tabletAbove the 7.5 mg recommended doseOnly on specific written medical directionNever more than one tablet per night
Transient insomnia7.5 mgShortly before going to bedTwo to five days
Short-term insomnia7.5 mgShortly before going to bedTwo to three weeks
Adults aged 65 and overStart at 3.75 mgShortly before going to bedAs short as possible
Liver impairment3.75 mg nightly recommendedShortly before going to bedAs short as possible
Severe liver impairmentDo not use zopicloneNot applicableNot applicable
Kidney impairmentStart at 3.75 mgShortly before going to bedAs short as possible
Chronic breathing problemsStart at 3.75 mgShortly before going to bedAs short as possible
History of drug or alcohol misuseHypnotics used only with clear cautionAs prescribedShortest possible course
Anyone under 18 yearsNot licensed; do not useNot applicableNot applicable
Pregnancy or breastfeedingUse is not recommendedNot applicableNot applicable

How to read this table:

Duration rules that matter most:

Missed dose and overdose rules:

How to Take Zopisign 10 mg

Practical usage tips:

Precautions

Absolute Contraindications – Do Not Use Zopisign 10 If You:

  • Are allergic to zopiclone or any tablet ingredient.
  • Have myasthenia gravis, a condition causing severe muscle weakness.
  • Have severe impairment of respiratory function.
  • Have sleep apnoea syndrome, where breathing stops during sleep.
  • Have severe liver impairment.
  • Have recently had an acute stroke.
  • Have drunk alcohol, or plan to drink alcohol, that day.
  • Have previously sleepwalked or driven while not fully awake on zopiclone.
  • Have done any other complex activity while asleep on this drug.
  • Are under 18 years of age.
  • Are pregnant, planning pregnancy or breastfeeding.

Conditions You Must Disclose to Your Doctor

  • Any liver disease, hepatitis or history of liver problems.
  • Any kidney disease or reduced kidney function.
  • Any lung disease, asthma, COPD or breathing difficulty.
  • Any snoring or suspected sleep apnoea.
  • Any history of alcohol misuse or drug dependence.
  • Any history of depression, anxiety or suicidal thoughts.
  • Any psychiatric illness or personality disorder.
  • Any previous episode of sleepwalking or night-time confusion.
  • Any memory problems or episodes of unexplained memory loss.
  • Any history of falls, especially if you are over 65.
  • Any lactose intolerance, since tablets may contain lactose.
  • Any opioid painkiller you take, including codeine and tramadol.
  • Any other sedative, sleeping tablet or muscle relaxant.
  • All prescription, herbal and over-the-counter products you use.
  • Any plan to drive, work shifts or operate machinery.

Food and Drink Precautions

  • Do not drink alcohol on any day you take this tablet.
  • Alcohol and zopiclone together deepen sedation dangerously.
  • Prior or concurrent alcohol use is a contraindication, not a caution.
  • Food does not meaningfully change zopiclone absorption.
  • There is no need to take the tablet on an empty stomach.
  • Grapefruit juice may raise zopiclone levels through CYP3A4.
  • Limit caffeine in the evening, as it works against the medicine.
  • Avoid herbal sedatives such as valerian without medical advice.
  • Do not use cannabis or other sedating substances with this tablet.

Before-Use Safety Checklist

  1. Has a doctor prescribed this exact strength for you?
  2. Have you asked whether 7.5 mg would be more appropriate?
  3. Do you know how many nights your course should last?
  4. Have you agreed a plan for stopping the medicine?
  5. Can you sleep seven to eight uninterrupted hours tonight?
  6. Have you confirmed you will not drink alcohol today?
  7. Have you disclosed any breathing or sleep apnoea problems?
  8. Have you disclosed any liver or kidney disease?
  9. Have you told your doctor about any opioid painkillers?
  10. Have you disclosed any history of dependence or misuse?
  11. Do you need to drive or work early tomorrow morning?
  12. Do you know the emergency warning signs in Section 8?

Common and Less Common Side Effects

A bitter or metallic taste is the most characteristic effect.

Side EffectFrequencyWhat It Feels LikeWhat to Do
Bitter or metallic tasteCommonPersistent odd taste, often on wakingUsually harmless; report if intolerable
Dry mouthCommonReduced saliva, thirst on wakingSip water; maintain dental hygiene
Next-day drowsinessCommonSleepiness or grogginess in the morningDo not drive; tell your doctor
HeadacheCommonDull ache on wakingRest and drink water; report if severe
Dizziness or unsteadinessCommonLight-headed or off-balance feelingMove slowly; take care on stairs
FatigueCommonUnusual tiredness during the dayReport if it continues
Nausea or indigestionLess commonQueasy or upset stomachReport if severe or persistent
Memory gaps (amnesia)Less commonNo memory of events after taking the doseStop and contact your doctor
ConfusionLess commonMuddled thinking, especially at nightContact your doctor promptly
Irritability or agitationLess commonFeeling tense, restless or short-temperedContact your doctor
Low moodLess commonFeeling flat, tearful or hopelessContact your doctor promptly
Rebound insomniaLess commonWorse sleep after stopping the medicineDo not restart alone; seek advice
Falls, especially in older adultsLess commonLoss of balance getting up at nightSeek medical review of the dose
Skin rash or itchingLess commonRed or itchy patches on the skinStop use and contact your doctor
ToleranceWith continued useThe usual dose stops working as wellDo not increase it; seek review
DependenceWith continued useFeeling unable to sleep without itSeek medical help to taper safely
Complex sleep behavioursRareSleepwalking, sleep-driving, eating while asleepStop immediately and get urgent advice
HallucinationsRareSeeing or hearing things that are not thereStop and seek urgent medical advice
Aggression or disinhibitionRareOut-of-character anger or behaviourStop and seek urgent medical advice
Respiratory depressionRareSlow, shallow or difficult breathingEmergency – call for help immediately
Severe allergic reactionRareSwelling of lips, face or throat; rashEmergency – call for help immediately
Suicidal thoughtsRareThoughts of self-harm or hopelessnessSeek urgent medical help the same day
  • Withdrawal symptoms can follow abrupt stopping after regular use.
  • These include headache, muscle pain and extreme anxiety.
  • They also include tension, restlessness, confusion and irritability.
  • A gradual taper reduces these effects considerably.
  • This list is not complete; report any unusual symptom.
  • Report suspected reactions to your national pharmacovigilance programme.

Drug Interactions – Avoid or Use With Caution

Never combine Zopisign 10 with these:

  • Alcohol in any quantity, including the evening before.
  • Opioid painkillers such as morphine, oxycodone, codeine and tramadol.
  • Opioid substitution treatments such as methadone and buprenorphine.
  • Other sleeping tablets, including zolpidem and zaleplon.
  • Benzodiazepines such as diazepam, lorazepam and temazepam.
  • Any other zopiclone or eszopiclone product.

Use only with medical supervision:

  • Sedating antihistamines such as promethazine and chlorphenamine.
  • Antipsychotic medicines, also called neuroleptics.
  • Antidepressants, particularly sedating ones.
  • Anti-anxiety medicines and muscle relaxants.
  • Anticonvulsant medicines used for epilepsy.
  • General anaesthetics before any planned procedure.
  • CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, ritonavir.
  • CYP3A4 inducers: rifampicin, carbamazepine, phenytoin, phenobarbital.
  • St John’s wort, which can reduce the medicine’s effect.
  • Grapefruit juice, which can raise zopiclone blood levels.

Interaction outcomes to understand:

  1. Opioids plus zopiclone can cause severe respiratory depression.
  2. That combination can lead to coma and death.
  3. Alcohol deepens sedation and raises the risk of choking or falls.
  4. Alcohol also raises the chance of complex sleep behaviours.
  5. CYP3A4 inhibitors raise zopiclone levels and next-day impairment.
  6. CYP3A4 inducers lower zopiclone levels and reduce its effect.
  7. Stacking sedatives is a common route to accidental overdose.

Emergency Warning Signs – Seek Urgent Medical Help

Call emergency services or go to hospital immediately if you have:

  • Slow, shallow or laboured breathing.
  • Blue-tinged lips, face or fingertips.
  • Extreme drowsiness that you cannot be roused from.
  • Loss of consciousness or unresponsiveness.
  • Severe confusion or disorientation.
  • Swelling of the face, lips, tongue or throat.
  • Widespread rash, hives or difficulty breathing or swallowing.
  • A seizure or convulsion.

Stop the medicine and contact a doctor the same day if you have:

  • Any episode of sleepwalking, sleep-driving or sleep-eating.
  • Any activity carried out while not fully awake.
  • No memory of a period after taking the tablet.
  • Hallucinations or seeing things that are not there.
  • Out-of-character aggression or agitation.
  • New or worsening low mood or hopelessness.
  • Any thoughts of harming yourself.

Critical instructions in an emergency:

  1. Tell every treating doctor you have taken zopiclone.
  2. State the strength, the amount and the time of the dose.
  3. State whether any alcohol, opioid or sedative was also taken.
  4. Bring the pack with you if that is possible.
  5. Never leave someone with slowed breathing to sleep it off.

If you are struggling emotionally, please speak to someone.

  • Persistent insomnia is often linked to low mood or anxiety.
  • A doctor can help with both the sleep and the underlying cause.
  • Local crisis helplines are available if you feel unsafe.

Why Choose This Medicine?

What zopiclone offers when it is clinically appropriate:

  1. It shortens the time taken to fall asleep.
  2. It reduces how often a person wakes during the night.
  3. It works quickly, usually within about an hour.
  4. Its half-life is shorter than many older sleeping tablets.
  5. It can help break a short cycle of acute, situational insomnia.
  6. It is well characterised in regulatory documents worldwide.
  7. HAB Pharmaceuticals manufactures in GMP-certified Indian facilities.
  8. Generic pricing keeps a short prescribed course affordable.

Honest balance for the buyer:

  • The 10 mg strength is above the recommended adult dose.
  • Higher doses add side effects without proven extra benefit.
  • Zopiclone causes tolerance, so it works less well over time.
  • It causes physical and psychological dependence.
  • Stopping suddenly after regular use causes withdrawal symptoms.
  • Rebound insomnia can make sleep temporarily worse on stopping.
  • It is licensed for weeks of use, not months or years.
  • Talking therapy for insomnia is the recommended long-term treatment.
  • That approach has lasting benefit without dependence risk.
  • Insomnia often signals stress, pain, depression or sleep apnoea.
  • Treating the cause matters more than sedating the symptom.
  • This is a controlled drug requiring a valid prescription.

Storage Instructions

  • Store at room temperature in a cool, dry place.
  • Keep tablets in the original blister until use.
  • Protect from direct sunlight, heat and moisture.
  • Do not store in the bathroom or near a sink.
  • Do not refrigerate or freeze the tablets.
  • Store the pack securely to prevent theft or misuse.
  • A lockable cupboard is advisable for a controlled drug.
  • Keep well out of sight and reach of children.
  • A single tablet can seriously harm a child.
  • Keep away from pets at all times.
  • Never share this medicine with another person.
  • Sharing a controlled drug is a criminal offence in many countries.
  • Check the expiry date printed on the blister and carton.
  • Do not use tablets that are chipped, discoloured or damp.
  • Do not transfer tablets into unlabelled containers.
  • Do not flush unused tablets down the toilet.
  • Return leftover tablets to a pharmacy take-back scheme.
Sanjay Gangani

Sanjay Gangani

B.Pharm, CMO & Pharmacist

Licensed pharmacist (B.Pharm) with 12+ years in clinical pharmacy and patient care. Reviews every article for evidence-based accuracy before it is published on ACTIZA Store.

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