Zopiclone is an active pharmaceutical ingredient in the Benzodiazepine Related Drugs group (N05CF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised July 8, 2025[1]
4 Administration 07/2024 7 WARNINGS AND PRECAUTIONS 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics (< 18 years of age) ..............................................................................................
2 Geriatrics (≥ 65 years of age) .............................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................
GBUnited Kingdom· MHRA
32 products
Uses
GBOfficial regulatory label· revised March 21, 2025[2]
Zopiclone is indicated for the treatment of insomnia in adults
How to take
GBOfficial regulatory label
Drug interactions
Known interactions involving Zopiclone. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02278030 · revised July 8, 2025
[2]MHRA (UK) · PL002892548 · revised March 21, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ....................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ...........................................................................................................
1 Pregnant Women .............................................................................................................. 2 Breast-feeding...................................................................................................................
3 Pediatrics (< 18 years of age): ........................................................................................... 4 Geriatrics (≥ 65 years of age): ...........................................................................................
17 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .................................................................................................
2 Drug Interactions Overview .............................................................................................. 3 Drug-Behavioural Interactions..........................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 22 PART II: SCIENTIFIC INFORMATION ......................................................................................
2 Comparative Bioavailability Study .................................................................................... 24 15 MICROBIOLOGY .......................................................................................................
24 16 […]
How to take
CAOfficial regulatory label· revised July 8, 2025[1]
4 Administration 07/2024 7 WARNINGS AND PRECAUTIONS 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics (< 18 years of age) ..............................................................................................
2 Geriatrics (≥ 65 years of age) .............................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ....................................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised July 8, 2025[1]
). It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while the medicinal product is being discontinued. RIVA-ZOPICLONE (zopiclone) Page 12 of 39 Driving and Operating Machinery CNS Depressant Effects and Next-Day Impairment: Like other sedative/hypnotic drugs, RIVA- ZOPICLONE has CNS-depressant effects.
Due to the rapid onset of action, RIVA-ZOPICLONE should be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug.
This includes potential impairment of the performance of such activities that may occur the day following ingestion of RIVA-ZOPICLONE. The risk of next day psychomotor impairment, including impaired driving, is increased if RIVA-ZOPICLONE is taken with less than a full night of sleep remaining; if a higher dose than the recommended dose is taken; if coadministered with other CNS depressants or drugs that increase the blood level of zopiclone.
Patients should be cautioned against taking RIVA- ZOPICLONE in these circumstances. RIVA-ZOPICLONE is not to be taken with alcohol or other sedative hypnotics (including other zopiclone products) at bedtime or the middle of the night.
If concomitant use of another CNS depressant or a drug that increases zopiclone blood levels is clinically warranted, dosage adjustments of RIVA-ZOPICLONE may be necessary. Even if RIVA-ZOPICLONE is taken as instructed, some patients may still have zopiclone blood levels in the morning high enough to produce impairment (see 4 DOSAGE AND ADMINISTRATION; and
CAOfficial regulatory label· Warnings and precautions· revised July 8, 2025[1]
4 Administration 07/2024 7 WARNINGS AND PRECAUTIONS 07/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics (< 18 years of age) ..............................................................................................
2 Geriatrics (≥ 65 years of age) .............................................................................................. 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ....................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ...........................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised July 8, 2025[1]
RIVA-ZOPICLONE is contraindicated in patients: • With known hypersensitivity to the drug or to any component in its formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. , significant sleep apnea syndrome).
• Who have previously experienced complex sleep behaviours after taking any non- benzodiazepine sedative-hypnotic. RIVA-ZOPICLONE (zopiclone) Page 5 of 39
This is not medical advice. Consult a qualified healthcare professional.
Posology Treatment with Zopiclone should be for as short a period as possible. 4). The period of treatment should generally vary between a few days to 2 weeks, with a maximum of 4 weeks including the tapering off phase. It is recommended that the patient should be informed of this prior to commencing treatment.
In certain cases it may be necessary to prolong treatment to beyond the maximum period. If this is the case, however, it should only take place after re-evaluation of the patient’s condition. 5 mg, taken by oral administration in an upright position 30 to 60 minutes before retiring.
Paediatric population Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established. 75mg zopiclone nightly is recommended.
5mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability. Renal insufficiency Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency.
75mg. 75 mg zopiclone is recommended initially. 5 mg. 4). Method of administration Oral. Each film coated tablet should be swallowed whole without sucking, chewing or breaking. Treatment should be started with the lowest recommended dose.
5 mg should not be exceeded.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 21, 2025[2]
List of adverse reactions The frequencies of adverse events are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Undesirable effects seem to be related to individual sensitivity and to appear more often during the first hour following intake. The following adverse reactions have been observed in patients treated with zopiclone: MedDRA system organ class Very commo n Commo n Rare Very rare Not known Immune system disorders Anaphylact ic reactions Psychiatric disorders Numbed emotions, confusion and depression2.
4). 4) 1 Amnesia Anterograde amnesia may occur on therapeutic doses, and the risk is increased the higher the dose. This undesirable effect has been observed rarely. 4). 4) Psychiatric and paradoxical reactions Reactions such as restlessness, agitation, irritability, aggression, delusions, outbursts of rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other behavioural disturbances may occur during the use of benzodiazepines and benzodiazepine-like substances.
In rare cases they may become quite severe with this agent. 4). 4). Psychological dependence may also occur. Misuse has been reported. 3 Predominantly at the beginning of treatment; generally disappears after repeated administration Withdrawal syndrome Withdrawal syndrome has been reported upon discontinuation of zopiclone.
4). Withdrawal symptoms vary and may include rebound insomnia, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability.
In very rare cases, seizures may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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GBOfficial regulatory label· Warnings and precautions· revised March 21, 2025[2]
Before starting treatment with zopiclone any underlying cause of insomnia should be addressed carefully. Dependence Clinical experience to date with Zopiclone suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks.
The use of benzodiazepines and benzodiazepine-like substances can lead to the development of physical and psychological dependence on these agents. This may occur not only with misuse of high doses but also with therapeutical doses.
The risk of dependence increases the higher the dose and the longer the period of treatment; the risk of dependence is also greater in patients with a history of alcohol or drug abuse or those who have marked personality disorders.
The decision to use a hypnotic in such patients should be taken only with this clearly in mind. These patients should be under careful surveillance when receiving zopiclone. 4). These may be expressed as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, insomnia and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise or physical contact, hallucinations or epileptic seizures. 8).
Rebound insomnia After discontinuation of treatment with a benzodiazepine or a benzodiazepine- like substance, a temporary syndrome may occur in where the treated symptoms return in a more severe form. It may be accompanied by other reactions, including mood changes, sleep disturbances, anxiety and restlessness.
Since the risk of withdrawal symptoms or rebound symptoms is greater after prolonged treatment, or abrupt interruption of the treatment it is advisable to reduce the dosage gradually. 2) and not longer than 4 weeks including the tapering off process.
This period should only be exceeded after re-evaluation of the patient’s condition. It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how the dose will be gradually reduced.
It is also important to point out to the patient the possibility of the occurrence of rebound phenomena in order to keep to a minimum any worries about the occurrence of such symptoms during the tapering off period of the treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 21, 2025[2]
2).
This is not medical advice. Consult a qualified healthcare professional.
1 Pregnant Women .............................................................................................................. 2 Breast-feeding...................................................................................................................
3 Pediatrics (< 18 years of age): ........................................................................................... 4 Geriatrics (≥ 65 years of age): ...........................................................................................
17 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .................................................................................................
2 Drug Interactions Overview .............................................................................................. 3 Drug-Behavioural Interactions..........................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 22 PART II: SCIENTIFIC INFORMATION ......................................................................................
In the case of benzodiazepines and benzodiazepine-like substances with a short period of action, there are indications that withdrawal symptoms may occur within the dosage interval, especially if the dose is high. Withdrawal The termination of treatment with Zopiclone is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks.
Patients may benefit from tapering of the dose before discontinuation. 8). Suicidal ideation/suicide attempt/suicide and depression Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone.
However, a causal relationship has not been established. As with other hypnotics, zopiclone does not constitute a treatment for depression and may even mask its symptoms (suicide may be precipitated in such patients). Zopiclone should be administered with caution in patients exhibiting symptoms of depression.
Suicidal tendencies may be present therefore the least amount of zopiclone that is feasible should be supplied to these patients to avoid the possibility of intentional overdosage by the patient. Pre-existing depression may be unmasked during use of zopiclone.
Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists. Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression.
Benzodiazepines and benzodiazepine like substances should not be used as the sole treatment for depression or anxiety linked with depression (suicide may be triggered in such patients). Tolerance The hypnotic effect of short-acting benzodiazepines and benzodiazepine-like substances may diminish after repeated use for a few weeks.
For zopiclone however, no pronounced tolerance has occurred during a treatment period of up to 4 weeks. Anterograde Amnesia Benzodiazepines and benzodiazepine-like substances may cause anterograde amnesia, especially when sleep is interrupted or when retiring to bed is delayed after taking the tablet.
8). Psychiatric and paradoxical reactions It is known that reactions such as restlessness, agitation, irritability, aggression, delusions, outbursts of rage, nightmares, hallucination, psychoses, inappropriate behaviour and other behavioural disturbances may occur during the use of benzodiazepines and benzodiazepine like substances.
If this is the case administration of the medicinal product should be discontinued. The risk of these reactions is greater in children and the elderly. 8). Benzodiazepines and benzodiazepine-like substances are not recommended as the primary treatment of psychoses.
Somnambulism and associated behaviours Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake.