It is not a treatment for depression, and may mask its symptoms.
It is not for use in anyone under 18.
It is not for long-term continuous use.
It is a prescription-only medicine.
Zopiclone is not marketed in the United States. The related medicine eszopiclone is available there instead.
How It Works (Mechanism of Action)
Zopiclone is a hypnotic agent of the cyclopyrrolone group.
It acts at central receptors belonging to the GABA macromolecular receptor complex.
Binding there modulates the opening of the chloride ion channel.
GABA is the main inhibitory neurotransmitter in the brain.
Enhancing its effect calms overactive nerve signalling.
This initiates and sustains sleep.
A Distinction from Benzodiazepines:
zopiclone and other cyclopyrrolones act at a different site from benzodiazepines, producing different conformational changes in the receptor complex. They nonetheless share dependence potential.
Why Falls are a Concern:
because of the muscle relaxant effect, there is a risk of falling, especially in elderly patients who get up during the night.
Dosage Guide
Patient Group
Approved Guidance
Key Notes
Adults, standard dose
7.5 mg
Shortly before retiring
Elderly patients
3.75 mg to start
May increase if clinically necessary
Hepatic dysfunction
3.75 mg nightly
7.5 mg with caution in some cases
Impaired renal function
3.75 mg to start
Chronic respiratory insufficiency
3.75 mg initially
May increase to 7.5 mg
Severe hepatic insufficiency
Contraindicated
May precipitate encephalopathy
Previous complex sleep behaviour
Contraindicated
Do not take zopiclone again
Under 18 years
Not to be used
Safety and efficacy not established
Taking CYP3A4 inhibitors
Dose reduction may be required
Erythromycin raises exposure 80%
Transient insomnia
2 to 5 days
Short term insomnia
2 to 3 weeks
Maximum course
4 weeks including tapering
Frequency
Single intake, once nightly
Never re-administer during the same night
Timing:
Take just before retiring for the night.
Food:
Absorption is not modified by food.
Swallowing:
UK tablets should be swallowed whole without sucking or chewing, though they carry a break line for dividing into equal doses.
Sleep opportunity:
Ensure about 7 to 8 hours of uninterrupted sleep.
Stopping:
Taper gradually; do not stop abruptly after regular use.
How to Take It
Take it exactly as your doctor prescribed.
Agree a plan for stopping before you start.
Swallow the tablet whole with water.
Do not suck, chew, or break the tablet.
Take it just before getting into bed.
Take it only when certain of retiring for the night.
Ensure about 7 to 8 hours of uninterrupted sleep.
It may be taken with or without food.
Take one dose only. Never take a second tablet in the same night.
Do not drink alcohol on any night you take it.
Do not take it with opioid painkillers.
Do not drive or use machinery for 12 hours afterwards.
Take particular care getting up during the night.
Do not use it for more than 4 weeks.
Do not stop suddenly after regular use.
Tell your doctor if you need more to get the same effect.
Do not share it with anyone else.
Precautions
Contraindications – Do Not Use If You
The following are formal contraindications in the approved product information.
Are hypersensitive to zopiclone or any excipient.
Have previously experienced complex sleep behaviours after taking zopiclone.
UK zopiclone 7.5 mg tablets contain 80 mg lactose monohydrate. Do not take them if you have rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
They contain 0.13 mg sodium per tablet, which is essentially sodium-free.
Use during pregnancy is not recommended.
Use in nursing mothers must be avoided.
Critical – opioids:
Concomitant use of zopiclone and opioids may result in sedation, respiratory depression, coma, and death. Reserve this combination for patients with no adequate alternative, at the lowest doses and shortest duration.
Critical – depression:
Zopiclone does not treat depression and may mask its symptoms; suicide may be precipitated in such patients. The least amount feasible should be supplied to patients with depressive symptoms, to avoid intentional overdose.
Conditions to Disclose to Your Doctor
Tell your doctor before use if you have or had:
Any previous sleep-walking or activity while not fully awake.
Any breathing or lung condition, including sleep apnoea.
Any liver disease.
Any kidney disease.
Myasthenia gravis or muscle weakness.
Depression, or any mental health condition.
Any thoughts of self-harm or suicide.
Any history of alcohol, substance, or drug misuse.
Any previous withdrawal symptoms from alcohol or drugs.
Any personality disorder.
Whether you have taken zopiclone or similar medicines for more than four weeks recently.
A history of falls, or difficulty getting up at night.
Whether you are pregnant, might be, or are breastfeeding.
Whether you drive or operate machinery.
Your age, since those 65 and over should start at 3.75 mg.
Every other medicine you take, including ones bought without prescription or online.
Food, Drink, and Lifestyle Precautions
Item
Effect
Recommendation
Alcohol
Enhances the sedative effect; affects ability to drive [Ref 1]
Concomitant use is not recommended
Opioid painkillers
Sedation, respiratory depression, coma, death [Ref 1]
Avoid unless specifically prescribed together
Narcotic analgesics
May enhance euphoria, increasing psychic dependence
Discuss with your doctor
Other sedatives and hypnotics
Additive CNS depression
Weigh carefully with your doctor
Food
Absorption is not modified by food
No restriction
Driving
Impairment for at least 12 hours
Do not drive for 12 hours
Getting up at night
Muscle relaxant effect raises fall risk
Take particular care
Before-Use Safety Checklist
A doctor has prescribed this medicine and this strength.
I have never had a complex sleep behaviour on zopiclone.
I am under 65; otherwise 3.75 mg is the starting dose.
I have no liver, kidney, or chronic respiratory impairment.
I have agreed a plan for stopping treatment.
I know the maximum course is 4 weeks.
I do not have myasthenia gravis, respiratory failure, or severe sleep apnoea.
I have 7 to 8 hours available for uninterrupted sleep.
I have drunk no alcohol tonight.
I take no opioids or other sedatives.
I will not drive or use machinery for 12 hours.
I am not taking a second dose tonight.
I have told my doctor about any history of substance misuse.
I have told my doctor about any depression.
I am not pregnant or breastfeeding.
I have a review date arranged.
The strip is sealed and the expiry date valid.
I know the emergency warning signs listed below.
Side Effects
Frequencies follow the approved product information.
Side Effect
Frequency
What To Do
Bitter or metallic taste (dysgeusia)
Common (1 in 100 to 1 in 10)
The most characteristic zopiclone effect
Residual drowsiness the next day
Common
Do not drive for 12 hours
Dry mouth
Common
Sip water
Dizziness
Uncommon (1 in 1,000 to 1 in 100)
Take care standing; fall risk
Headache
Uncommon
Usually mild
Nightmares
Uncommon
Report if troublesome
Agitation
Uncommon
Tell your doctor
Nausea or vomiting
Uncommon
Report if persistent
Fatigue
Uncommon
Report if persistent
Confusional state
Rare (1 in 10,000 to 1 in 1,000)
Contact your doctor
Changes in libido
Rare
Discuss at review
Irritability or aggression
Rare
Stop and contact your doctor
Hallucinations
Rare
Stop and contact your doctor
Anterograde amnesia
Rare
Ensure a full night’s sleep
Breathlessness
Rare
Seek medical advice
Rash, hives, or itching
Rare
Stop use; contact your doctor
Falls, predominantly in elderly patients
Rare
Take care at night
Angioedema or anaphylaxis
Very rare
Emergency; stop immediately
Raised liver enzymes
Very rare
Your doctor may check liver function
Restlessness, delusion, anger
Not known
Stop and contact your doctor
Depressed mood
Not known
Contact your doctor promptly
Abnormal behaviour with amnesia
Not known
Stop; see section 8
Sleep-walking and related behaviours
Not known
Stop permanently; see section 8
Drug dependence
Not known
Do not stop abruptly; seek advice
Withdrawal syndrome
Not known
See below
Respiratory depression
Not known
Emergency
Memory impairment or attention disturbance
Not known
Contact your doctor
Unsteadiness, pins and needles, speech disorder
Not known
Contact your doctor
Double vision
Not known
Do not drive; contact your doctor
Muscular weakness
Not known
Contact your doctor
Paradoxical reactions:
Restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations and inappropriate behaviour are known to occur with sedative-hypnotics. These are more likely in the elderly. If they occur, zopiclone should be discontinued.
Rebound insomnia:
is a transient return of the original symptoms in an enhanced form on stopping, sometimes with mood changes, anxiety and restlessness. It is more likely after prolonged or abrupt discontinuation.
Drug Interactions
Antipsychotics and narcoleptics.
Other hypnotics and sedatives.
Anxiolytics.
Antidepressants.
Narcotic analgesics, which may also enhance euphoria and increase psychic dependence.
Anti-epileptic medicines.
Anaesthetics.
Sedating antihistamines.
Opioids specifically:
concomitant use increases the risk of sedation, respiratory depression, coma and death. Limit dosage and duration.
Raise zopiclone levels – dose reduction may be required:
Erythromycin, which increased zopiclone exposure by 80%.
Clarithromycin.
Ketoconazole and itraconazole.
Ritonavir.
Rifampicin.
Carbamazepine, phenobarbital, phenytoin.
St John’s Wort.
Give your doctor a comprehensive medication history, including over-the-counter medicines and anything obtained online.
Emergency Warning Signs
Seek immediate medical care if you or someone else experiences:
Sleep-walking, sleep-driving, or other activity while not fully awake.
Waking to evidence of activity you do not remember.
Difficulty breathing, or very shallow breathing.
Extreme drowsiness or difficulty waking.
Confusion or disorientation.
Hallucinations.
Aggression or markedly out-of-character behavior.
Swelling of the face, lips, tongue, or throat.
Widespread rash or hives.
A fall causing injury.
A seizure.
New or worsening low mood or thoughts of self-harm.
Tell emergency staff you have taken zopiclone. State the dose and time. Mention any alcohol, opioids, or other sedatives. Bring the pack if you can.
Why Choose Zopicon 7.5 mg
Genuine advantages:
7.5 mg is the standard approved adult dose of zopiclone.
Made by Intas Pharmaceuticals, a major Indian pharmaceutical company.
Listed on Apollo Pharmacy, one of India’s largest pharmacy chains.
It initiates and sustains sleep without reducing total REM sleep.
Slow wave sleep is preserved.
Absorption is not affected by food.
Effects typically begin within about 30 minutes.
No marked tolerance develops over treatment periods of up to 4 weeks.
Zopiclone is licensed in the UK and widely used internationally.
Honest limitations you should know:
It is for short-term use only, with a 4-week maximum.
Dependence can occur even with short-term use at recommended doses.
A stopping strategy should be agreed before starting.
Driving is not advised for 12 hours afterwards.
Residual next-day drowsiness is a common effect.
A bitter or metallic taste is common and often persistent.
It is not the correct starting dose for anyone over 65.
It is not the correct starting dose in liver, kidney, or respiratory impairment.
Paradoxical reactions are more likely in the elderly.
It does not treat depression and may mask it.
You are aged 65 or over.
You have any liver dysfunction.
You have impaired kidney function.
You have chronic respiratory insufficiency.
Consider a different approach if:
Your insomnia has lasted more than a few weeks.
You have untreated depression, anxiety, or pain disturbing your sleep.
You have sleep apnea or any breathing difficulty.
You have a history of substance dependence.
You cannot reliably allow 7 to 8 hours for sleep.
You must drive within 12 hours of your usual waking time.
Cognitive behavioral therapy for insomnia, generally recommended first-line.
A consistent sleep and waking schedule.
Reviewing caffeine, alcohol, and screen use in the evening.
Treating any underlying medical or psychiatric cause.
Bottom line:
Zopiclone at the standard adult dose from a major manufacturer, which is the strongest sourcing position of the zopiclone products in this catalogue. Used within four weeks, with a stopping plan agreed in advance and 12 hours clear of driving, it is a well-characterised short-term treatment.
Storage Instructions
Store below 30°C in a cool, dry place.
Keep tablets in the original strip until use.
Store securely, out of the sight and reach of children.
Accidental ingestion by a child is a medical emergency.
Do not keep it beside the bed if you are prone to night-time confusion.
Do not transfer tablets into unlabelled containers.
Keep the original pack for the drug name and strength.
Keep the original pack for the drug name and strength.
The same brand is also sold at 10 mg, above the approved adult dose.
Do not freeze or refrigerate.
Check the expiry date printed on the pack.
Never use tablets after the expiry date.
Never share this medicine with anyone else.
Return unused tablets to a pharmacy for disposal.
Do not flush tablets or throw them in household waste.
Medical Disclaimer
This content is for information only. It is not medical advice. Zopiclone is a prescription-only medicine and a cyclopyrrolone hypnotic. 7.5 mg is the recommended adult dose, taken as a single intake shortly before retiring and never re-administered during the same night.
Patients aged 65 and over, and those with hepatic dysfunction, impaired renal function or chronic respiratory insufficiency, should start at 3.75 mg. Zopiclone is contraindicated in anyone who has previously experienced complex sleep behaviours after taking it, and in myasthenia gravis, respiratory failure, severe sleep apnoea and severe hepatic insufficiency.
A single course should not continue longer than 4 weeks including tapering, and a strategy for ending treatment should be agreed before starting. Dependence and addiction can occur even with short-term use at recommended doses; do not stop abruptly.
Do not drink alcohol or take opioids with this medicine. Allow about 7 to 8 hours for uninterrupted sleep, and do not drive or operate machinery for 12 hours after taking it. Use only under a qualified doctor’s supervision.
If your sleep problems persist, speak to a doctor. Insomnia can be a symptom of another condition, and effective non-drug treatments exist.
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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