ZOPIVANE is a prescription sleep medicine used for short-term relief of insomnia (sleeplessness) in adults. It contains zopiclone (7.5 mg) and belongs to a group of medicines called sedative–hypnotics. These medicines help you fall asleep and stay asleep, but they are intended for brief courses only. ZOPIVANE is Schedule 5 (S5) in South Africa, which means it should be taken exactly as advised by your healthcare professional and not shared with anyone else.
What it is and what it is used for
ZOPIVANE (zopiclone) is a sedative–hypnotic. It is prescribed for short-term management of insomnia in adult patients who:
- struggle to fall asleep at bedtime,
- wake up often during the night, and/or
- wake up too early.
Treatment is intended to be brief—typically a few days to two weeks—and always under a doctor’s supervision.
How it works
Zopiclone acts on the brain to slow down overactivity that can keep you awake. In everyday terms, it calms the nervous system, helping you fall asleep more easily and maintain sleep. Because it affects brain activity, it can also cause daytime drowsiness or slowed reactions, especially if you do not get a full night’s rest.
Note: To lessen memory problems and morning grogginess, only take ZOPIVANE when you can have 7–8 hours of uninterrupted sleep.
Who should NOT use this medicine
Do not take ZOPIVANE if any of the following apply:
- You are allergic or hypersensitive to zopiclone or any of the ingredients in ZOPIVANE.
- You have myasthenia gravis (a condition causing severe muscle weakness).
- You have breathing difficulties or respiratory depression (very slow breathing).
- You have severe liver problems.
- You have sleep apnoea (stop breathing for short periods during sleep).
- You have pre-existing central nervous system (CNS) depression, which may present as very slow breathing (fewer than 10 breaths per minute), low heart rate, extreme confusion or memory loss, nausea and vomiting, poor judgement, bluish lips or fingertips, irritability or aggression, and clammy or cold skin.
- You are under 18 years of age.
- You are pregnant or breastfeeding.
Warning: If you are unsure about any of the conditions above, speak to your doctor or pharmacist before taking a dose.
Warnings and precautions
Before starting ZOPIVANE, tell your healthcare professional about all your health conditions and medicines. Use extra caution in the situations below:
- History of alcohol or drug misuse: There is a risk of abuse and dependence, which increases with higher doses, longer treatment (especially beyond 4 weeks), and in people with a history of mental health conditions or substance misuse.
- Elderly: You may be more sensitive to side effects such as clumsiness, unsteadiness, falls, and confusion.
- Liver or kidney problems: Your doctor may prescribe a lower dose (exact amounts not specified in the source).
- Respiratory depression: If your breathing is slow, this medicine can worsen it.
- Other mental health conditions: If you have depression, a personality disorder, or any past mental illness, talk to your doctor. Some sedative–hypnotics (including zopiclone) have been associated with suicidal thoughts or behaviour in some studies. Seek help immediately if you experience suicidal thoughts.
- Concomitant use with opioids or other CNS depressants: Combining ZOPIVANE with opioids (e.g., codeine, morphine, oxycodone, tramadol), alcohol, or other sedatives greatly increases the risk of profound drowsiness, breathing problems, coma, and death.
- Sleep-related behaviours: Sleepwalking and unusual behaviours have been reported. If they occur, contact your doctor.
- Rebound insomnia and withdrawal: Stopping suddenly can cause anxiety, restlessness, mood changes, and a temporary return or worsening of sleep problems.
- Ability to function the next day: ZOPIVANE may cause drowsiness, dizziness, and impaired coordination the following day. Only drive or operate machinery once you know how ZOPIVANE affects you.
Note: If unusual or disturbing thoughts or behaviour develop, contact your doctor without delay.
Pregnancy, planning pregnancy, and breastfeeding
- Pregnancy: Do not use ZOPIVANE if you are pregnant.
- Breastfeeding: Do not use ZOPIVANE if you are breastfeeding.
- If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, speak to your doctor or pharmacist for advice before using any medicine.
Interactions
Always tell your doctor or pharmacist about all medicines you are taking (including complementary or traditional products).
Medicines and substances that increase ZOPIVANE’s effects or side effects
- Alcohol
- Antipsychotics (for mental health conditions)
- Antidepressants
- Anticonvulsants (for epilepsy)
- Anaesthetics (used in surgery)
- Hypnotics/sedatives (other sleep or anxiety medicines)
- Sedating antihistamines (e.g., chlorphenamine, promethazine)
- Opioid pain medicines (e.g., codeine, methadone, morphine, oxycodone, pethidine, tramadol) → markedly increases risk of drowsiness, breathing problems, coma, death
- Medicines that can raise zopiclone levels and thereby increase side effects: some antibiotics (e.g., clarithromycin, erythromycin), some antifungals (e.g., ketoconazole, itraconazole), and ritonavir (for HIV)
Medicines and products that can make ZOPIVANE less effective
- Some antiepileptics: carbamazepine, phenobarbital, phenytoin
- Rifampicin (antibiotic)
- St John’s Wort (herbal product used for mood symptoms)
Food, drink, and alcohol
- Alcohol must be avoided. Combining alcohol with ZOPIVANE can lead to very deep sleep, breathing problems, and difficulty waking.
- Food.
How to take
Always take ZOPIVANE exactly as your doctor or pharmacist has told you. If you are uncertain, check with them first.
Step-by-step guide
- Timing: Take your tablet immediately before going to bed.
- Dose: The usual adult dose is one tablet (7,5 mg) at bedtime. Do not exceed this dose.
- Sleep window: Only take a dose when you can have 7–8 hours of uninterrupted sleep.
- Special populations: Your doctor may lower the dose if you are elderly or if you have liver or kidney problems (exact reduced doses are not specified in the source).
- Length of treatment: Your doctor will tell you how long to use ZOPIVANE. It is intended for short-term use (a few days to two weeks).
- If the effect feels too strong or too weak: Speak to your doctor or pharmacist—do not change the dose on your own.
- Missed dose: If you forget a dose, do not take an extra tablet to make up for it. Simply take your next dose at bedtime as usual.
- Overdose: If you take more than prescribed, contact your doctor or pharmacist immediately. If they are unavailable, go to the nearest hospital or poison control centre.
- Stopping treatment: Do not stop suddenly. Check with your doctor first; a gradual dose reduction may be needed to reduce withdrawal and rebound symptoms.
Practical tips for adherence
- Build a simple bedtime routine (same time every night).
- Set an alarm not to remind you to take the medicine, but to start winding down so you can achieve a full night’s sleep after the dose.
- Keep the medication in one secure place, out of sight and reach of children.
Dosing table
Important: Only the dosing information provided in the source is included. If your doctor gives different advice, follow their instructions.
| Patient group | Dose | When to take | Frequency | Maximum daily dose |
|---|---|---|---|---|
| Adults | 1 tablet (7,5 mg) | Immediately before going to bed | Once daily at bedtime | Do not exceed 1 tablet at bedtime (source states the usual adult dose should not be exceeded) |
| Elderly | Doctor may prescribe a lower dose | At bedtime | As directed | Not specified in the source |
| Liver impairment | Doctor may prescribe a lower dose | At bedtime | As directed | Not specified in the source |
| Kidney impairment | Doctor may prescribe a lower dose | At bedtime | As directed | Not specified in the source |
| Under 18 years | Do not use | — | — | — |
Note: Food-taking instructions are not specified in the source. Alcohol must be avoided.
Possible side effects
Not everyone experiences side effects, but ZOPIVANE can cause them. If your general health worsens while using ZOPIVANE, speak to your doctor, pharmacist, or nurse.
Serious—seek urgent help
Stop taking ZOPIVANE and get immediate medical help if you experience:
- Allergic reactions: swelling of the hands, feet, ankles, face, lips, mouth, or throat (may cause trouble swallowing or breathing), rash or itching.
- Severe mental or behavioural changes:
- Hallucinations (seeing or hearing things that are not real)
- Delusions (strong beliefs that are not true)
- Depressed mood or suicidal thoughts/behaviour
- Falls, especially in older adults
- Severe memory problems (amnesia). Getting 7–8 hours of sleep lowers this risk.
These effects can require urgent assessment.
Common
- Dizziness
- Sleepiness, drowsiness, or feeling unsteady on waking
- Bitter taste in the mouth
- Indigestion, nausea, dry mouth
Less common
- Headache, memory problems, nightmares
- Feeling confused or irritable
- Reduced sex drive
- Shortness of breath or difficulty breathing
- Raised liver function tests
- Feeling physically or mentally tired
- Aggressiveness or inappropriate behaviour (sometimes with memory problems)
Frequency not known
- Feeling restless or angry
- Sleepwalking
- Dependence on ZOPIVANE
- Abnormal skin sensations (e.g., numbness, tingling, burning, crawling—paraesthesia)
- Feeling light-headed, poor coordination
- Attention difficulties, speech disturbances, double vision
- Slower breathing (respiratory depression)
- Muscle weakness
Rebound and withdrawal
When treatment is stopped, you may notice anxiety, restlessness, mood changes, and a temporary worsening of insomnia. This is more likely if therapy is stopped suddenly.
What to do: If side effects are severe, persistent, or worry you, contact your doctor or pharmacist. Report suspected side effects to your healthcare professional. (The source also lists contact pathways for reporting in South Africa.)
Storage and disposal
- Temperature: Store at or below 25 °C in a cool, dry place.
- Light: Protect from light.
- Moisture: Do not keep in the bathroom, near the kitchen sink, or other damp places.
- Safety: Store out of reach of children.
- Disposal: Return unused tablets to your pharmacist. Do not dispose of medicines in drains or toilets.
What the medicine contains
- Active ingredient: Zopiclone 7,5 mg per film-coated tablet.
- Excipients (inactive ingredients): Colloidal silicon dioxide (Aerosil 200), lactose monohydrate, magnesium stearate, maize starch, opadry QX321A180025 (glycerol monocaprylocaprate, macrogol (PEG) polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc, titanium dioxide), sodium starch glycolate.
Contains sugar: lactose. The source leaflet specifies lactose monohydrate 40 000 mg per tablet (stated as recorded in the source).
If you have been told you have lactose intolerance, speak to your doctor before taking ZOPIVANE.
Pack information and appearance
- Appearance: White, film-coated, oblong, shallow-convex tablets with a central break-line on one side and plain on the other.
- Packs: Blister strips of 10 tablets, supplied in 30-tablet cartons.
- Scheduling status: S5 (South Africa).
- Holder of Certificate of Registration: CIPLA MEDPRO (PTY) LTD.
- Registration number: 35/2.2/0021
- Customer Care: 080 222 6662 (as per source leaflet)
FAQs
Can I use ZOPIVANE if I’m pregnant or breastfeeding?
No. Do not use during pregnancy or breastfeeding. If you are pregnant, think you may be, are planning a pregnancy, or are breastfeeding, consult your healthcare professional for advice.
Can children or teens take ZOPIVANE?
No. ZOPIVANE should not be used by anyone under 18 years.
Can I drink alcohol while taking ZOPIVANE?
No. Alcohol must be avoided. It can greatly increase sedation, cause very deep sleep, breathing problems, and difficulty waking.
What if I miss a dose?
Do not take a double dose. Skip the missed dose and take your usual dose at bedtime the next day.
Can I stop ZOPIVANE suddenly?
Do not stop abruptly. Speak to your doctor. A gradual dose reduction may be required to reduce withdrawal and rebound insomnia.
When should I take my tablet?
Take immediately before going to bed, only when you can have 7–8 hours of uninterrupted sleep.
Is ZOPIVANE habit-forming?
Dependence can occur, especially at higher doses, with longer than 4 weeks of use, or in people with a history of mental health disorders or substance misuse. Use short-term and exactly as prescribed.
Can I drive or use machines?
ZOPIVANE can cause drowsiness and slower reactions the next day, particularly within 12 hours of a dose, at higher than recommended doses, or if taken with alcohol/other CNS depressants. Do not drive or operate machinery until you know how it affects you.
What if I feel the tablet is too strong or too weak?
Do not change the dose yourself. Speak to your doctor or pharmacist.
How should I store and dispose of it?
Store at or below 25 °C, protected from light, in a dry place. Keep away from children. Return unused tablets to your pharmacist; do not flush or pour down drains.
Manish Sharma is a Master’s graduate in Pharmaceutical Chemistry and a registered pharmacist with a passion for simplifying medical knowledge for everyday readers. Through his platform, he provides clear, easy-to-understand information about medicines — including their correct usage, benefits, and safety tips — while also addressing common myths surrounding them.
Alongside modern medicine, Manish also explores natural and herbal remedies, encouraging a balanced and healthy lifestyle. His mission is to empower people with reliable health information, helping them make informed decisions and live healthier, happier lives.
