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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 Situation | Licensed Zopiclone Dose | Timing | Maximum Duration |
|---|---|---|---|
| Adults, recommended dose | 7.5 mg | Shortly before going to bed | Four weeks including tapering |
| Zopisign 10 mg tablet | Above the 7.5 mg recommended dose | Only on specific written medical direction | Never more than one tablet per night |
| Transient insomnia | 7.5 mg | Shortly before going to bed | Two to five days |
| Short-term insomnia | 7.5 mg | Shortly before going to bed | Two to three weeks |
| Adults aged 65 and over | Start at 3.75 mg | Shortly before going to bed | As short as possible |
| Liver impairment | 3.75 mg nightly recommended | Shortly before going to bed | As short as possible |
| Severe liver impairment | Do not use zopiclone | Not applicable | Not applicable |
| Kidney impairment | Start at 3.75 mg | Shortly before going to bed | As short as possible |
| Chronic breathing problems | Start at 3.75 mg | Shortly before going to bed | As short as possible |
| History of drug or alcohol misuse | Hypnotics used only with clear caution | As prescribed | Shortest possible course |
| Anyone under 18 years | Not licensed; do not use | Not applicable | Not applicable |
| Pregnancy or breastfeeding | Use is not recommended | Not applicable | Not 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
- Has a doctor prescribed this exact strength for you?
- Have you asked whether 7.5 mg would be more appropriate?
- Do you know how many nights your course should last?
- Have you agreed a plan for stopping the medicine?
- Can you sleep seven to eight uninterrupted hours tonight?
- Have you confirmed you will not drink alcohol today?
- Have you disclosed any breathing or sleep apnoea problems?
- Have you disclosed any liver or kidney disease?
- Have you told your doctor about any opioid painkillers?
- Have you disclosed any history of dependence or misuse?
- Do you need to drive or work early tomorrow morning?
- 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 Effect | Frequency | What It Feels Like | What to Do |
|---|---|---|---|
| Bitter or metallic taste | Common | Persistent odd taste, often on waking | Usually harmless; report if intolerable |
| Dry mouth | Common | Reduced saliva, thirst on waking | Sip water; maintain dental hygiene |
| Next-day drowsiness | Common | Sleepiness or grogginess in the morning | Do not drive; tell your doctor |
| Headache | Common | Dull ache on waking | Rest and drink water; report if severe |
| Dizziness or unsteadiness | Common | Light-headed or off-balance feeling | Move slowly; take care on stairs |
| Fatigue | Common | Unusual tiredness during the day | Report if it continues |
| Nausea or indigestion | Less common | Queasy or upset stomach | Report if severe or persistent |
| Memory gaps (amnesia) | Less common | No memory of events after taking the dose | Stop and contact your doctor |
| Confusion | Less common | Muddled thinking, especially at night | Contact your doctor promptly |
| Irritability or agitation | Less common | Feeling tense, restless or short-tempered | Contact your doctor |
| Low mood | Less common | Feeling flat, tearful or hopeless | Contact your doctor promptly |
| Rebound insomnia | Less common | Worse sleep after stopping the medicine | Do not restart alone; seek advice |
| Falls, especially in older adults | Less common | Loss of balance getting up at night | Seek medical review of the dose |
| Skin rash or itching | Less common | Red or itchy patches on the skin | Stop use and contact your doctor |
| Tolerance | With continued use | The usual dose stops working as well | Do not increase it; seek review |
| Dependence | With continued use | Feeling unable to sleep without it | Seek medical help to taper safely |
| Complex sleep behaviours | Rare | Sleepwalking, sleep-driving, eating while asleep | Stop immediately and get urgent advice |
| Hallucinations | Rare | Seeing or hearing things that are not there | Stop and seek urgent medical advice |
| Aggression or disinhibition | Rare | Out-of-character anger or behaviour | Stop and seek urgent medical advice |
| Respiratory depression | Rare | Slow, shallow or difficult breathing | Emergency – call for help immediately |
| Severe allergic reaction | Rare | Swelling of lips, face or throat; rash | Emergency – call for help immediately |
| Suicidal thoughts | Rare | Thoughts of self-harm or hopelessness | Seek 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:
- Opioids plus zopiclone can cause severe respiratory depression.
- That combination can lead to coma and death.
- Alcohol deepens sedation and raises the risk of choking or falls.
- Alcohol also raises the chance of complex sleep behaviours.
- CYP3A4 inhibitors raise zopiclone levels and next-day impairment.
- CYP3A4 inducers lower zopiclone levels and reduce its effect.
- 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:
- Tell every treating doctor you have taken zopiclone.
- State the strength, the amount and the time of the dose.
- State whether any alcohol, opioid or sedative was also taken.
- Bring the pack with you if that is possible.
- 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:
- It shortens the time taken to fall asleep.
- It reduces how often a person wakes during the night.
- It works quickly, usually within about an hour.
- Its half-life is shorter than many older sleeping tablets.
- It can help break a short cycle of acute, situational insomnia.
- It is well characterised in regulatory documents worldwide.
- HAB Pharmaceuticals manufactures in GMP-certified Indian facilities.
- 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.

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