Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
History of complex sleep behaviour after taking zopiclone
Myasthenia gravis
Pregnancy
Respiratory failure
Severe hepatic impairment
Sleep apnoea

Precautions and Warnings

Elderly
Chronic respiratory impairment
Depression
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
Lactose intolerance
Mild hepatic impairment
Psychiatric disorder
Renal impairment

Consider dose modification in patients with respiratory depression
May unmask pre-existing depression during treatment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not suitable as sole treatment of depression or anxiety with depression
Contains lactose
Discontinue treatment if sleep walking or other associated behaviours occur
Potential for drug abuse
Tolerance and dependence may occur
Discontinue if psychiatric disturbances develop
Potential for withdrawal symptoms
Rebound effect may occur after cessation of treatment
Progressive withdrawal recommended especially after 4 weeks therapy
Limit prescribing quantity due to suicide risk
Reduce dose in elderly
Lowest dose should be used to control symptoms - treatment time max 4 weeks
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient to consult a doctor if symptoms persist despite treatment
Advise patient to ensure 7- 8 hours of uninterrupted sleep/rest post dose

The cause of insomnia should be identified wherever possible and the underlying factors treated before zopiclone is prescribed.

The risk of dependence increases with dose and duration of treatment particularly if used for longer than 4 weeks. Dependence is more likely to occur in patients with a history of psychiatric disorders and or alcohol, substance or drug abuse.

Zopiclone does not constitute a treatment for depression and may even mask its symptoms. Caution should be taken in patients displaying symptoms of depression. Underlying causes of insomnia should be addressed before symptomatic treatment.

Patients should be advised to ensure that they take the tablet when certain of retiring for the night and they are able to have uninterrupted sleep of about 7 to 8 hours to reduce the risk of anterograde amnesia.

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 following administration of zopiclone and in particular during the 12 hours following that administration.

Sleep walking and other associated behaviours ('sleep driving', preparing and eating food, making phone calls) with amnesia have been reported. The risk of such behaviour appears to be increased by the use of alcohol and other CNS-depressants, or doses of zopiclone exceeding the maximum recommended dose. Discontinuation should be strongly considered in patients experiencing such behaviour.

Pregnancy and Lactation

Pregnancy

Zopiclone is contraindicated in pregnancy.

Zopiclone crosses the placenta however, experience of zopiclone use during pregnancy in humans has not demonstrated evidence of malformations. Although, there have been increased incidences of cleft lip and palate associated with use of benzodiazepines during pregnancy.

Cases of reduced foetal movement and foetal heart rate variability have been seen particularly during the second and third trimester. Administration during the late phase of pregnancy or during labour have been associated with adverse effects on the neonate, such as hypothermia, hypotonia, feeding difficulties and respiratory depression, due to the pharmacological action of the product. Moreover, infants born to mothers who took sedative/hypnotics agents chronically during the end stages of pregnancy may have developed physical dependence and experience withdrawal symptoms in the post natal period. It is advised to monitor the newborn.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

If prescribed to a woman of child bearing potential, she should be advised to contact her physician about discontinuing treatment if she intends to become, or suspects she is pregnant.

Lactation

Zopiclone is contraindicated in breastfeeding.

Zopiclone is excreted in breast milk. Schaefer (2015) concludes that a single dose of zopiclone is tolerable during breastfeeding, but in general should be avoided.

There is limited information regarding the use of zopiclone during breastfeeding, it is therefore advised an alternate hypnotic may be used, particularly when nursing the newborn.

Side Effects

Aggression
Agitation
Allergic reaction
Anaphylactic reaction
Anger
Angioedema
Anterograde amnesia
Ataxia
Attention disturbances
Behavioural disturbances
Bitter taste
Changes in libido
Confusion
Delusions
Dependence
Depressed mood
Diplopia
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Erythema multiforme
Falls
Fatigue
Flat affect
Gastro-intestinal symptoms
Hallucinations
Headache
Impaired memory
Inco-ordination
Increase in alkaline phosphatase
Increase in serum transaminases
Irritability
Light-headedness
Metallic taste
Muscle weakness
Nausea
Nightmares
Paradoxical reactions
Paraesthesia
Pruritus
Rash
Respiratory depression
Restlessness
Sleep walking
Somnolence
Speech disturbances
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Urticaria
Vomiting
Withdrawal symptoms

Presentation

Oral formulations of zopiclone.

Drugs List

Therapeutic Indications

Uses

Insomnia (short-term treatment)

Dosage

Use the lowest effective dose. Zopiclone should be taken in a single intake and not be re-administered during the same night.

Treatment should not exceed 4 weeks including the tapering off period.

Adults

Elderly

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
History of complex sleep behaviour after taking zopiclone
Myasthenia gravis
Pregnancy
Respiratory failure
Severe hepatic impairment
Sleep apnoea

Precautions and Warnings

Elderly
Chronic respiratory impairment
Depression
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of drug misuse
History of psychiatric disorder
Lactose intolerance
Mild hepatic impairment
Psychiatric disorder
Renal impairment

Consider dose modification in patients with respiratory depression
May unmask pre-existing depression during treatment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Not suitable as sole treatment of depression or anxiety with depression
Contains lactose
Discontinue treatment if sleep walking or other associated behaviours occur
Potential for drug abuse
Tolerance and dependence may occur
Discontinue if psychiatric disturbances develop
Potential for withdrawal symptoms
Rebound effect may occur after cessation of treatment
Progressive withdrawal recommended especially after 4 weeks therapy
Limit prescribing quantity due to suicide risk
Reduce dose in elderly
Lowest dose should be used to control symptoms - treatment time max 4 weeks
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient to consult a doctor if symptoms persist despite treatment
Advise patient to ensure 7- 8 hours of uninterrupted sleep/rest post dose

The cause of insomnia should be identified wherever possible and the underlying factors treated before zopiclone is prescribed.

The risk of dependence increases with dose and duration of treatment particularly if used for longer than 4 weeks. Dependence is more likely to occur in patients with a history of psychiatric disorders and or alcohol, substance or drug abuse.

Zopiclone does not constitute a treatment for depression and may even mask its symptoms. Caution should be taken in patients displaying symptoms of depression. Underlying causes of insomnia should be addressed before symptomatic treatment.

Patients should be advised to ensure that they take the tablet when certain of retiring for the night and they are able to have uninterrupted sleep of about 7 to 8 hours to reduce the risk of anterograde amnesia.

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 following administration of zopiclone and in particular during the 12 hours following that administration.

Sleep walking and other associated behaviours ('sleep driving', preparing and eating food, making phone calls) with amnesia have been reported. The risk of such behaviour appears to be increased by the use of alcohol and other CNS-depressants, or doses of zopiclone exceeding the maximum recommended dose. Discontinuation should be strongly considered in patients experiencing such behaviour.

Pregnancy and Lactation

Pregnancy

Zopiclone is contraindicated in pregnancy.

Zopiclone crosses the placenta however, experience of zopiclone use during pregnancy in humans has not demonstrated evidence of malformations. Although, there have been increased incidences of cleft lip and palate associated with use of benzodiazepines during pregnancy.

Cases of reduced foetal movement and foetal heart rate variability have been seen particularly during the second and third trimester. Administration during the late phase of pregnancy or during labour have been associated with adverse effects on the neonate, such as hypothermia, hypotonia, feeding difficulties and respiratory depression, due to the pharmacological action of the product. Moreover, infants born to mothers who took sedative/hypnotics agents chronically during the end stages of pregnancy may have developed physical dependence and experience withdrawal symptoms in the post natal period. It is advised to monitor the newborn.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

If prescribed to a woman of child bearing potential, she should be advised to contact her physician about discontinuing treatment if she intends to become, or suspects she is pregnant.

Lactation

Zopiclone is contraindicated in breastfeeding.

Zopiclone is excreted in breast milk. Schaefer (2015) concludes that a single dose of zopiclone is tolerable during breastfeeding, but in general should be avoided.

There is limited information regarding the use of zopiclone during breastfeeding, it is therefore advised an alternate hypnotic may be used, particularly when nursing the newborn.

Effects on Ability to Drive and Operate Machinery

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 following administration of zopiclone and in particular during the 12 hours following that administration.

Side Effects

Aggression
Agitation
Allergic reaction
Anaphylactic reaction
Anger
Angioedema
Anterograde amnesia
Ataxia
Attention disturbances
Behavioural disturbances
Bitter taste
Changes in libido
Confusion
Delusions
Dependence
Depressed mood
Diplopia
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Dyspnoea
Erythema multiforme
Falls
Fatigue
Flat affect
Gastro-intestinal symptoms
Hallucinations
Headache
Impaired memory
Inco-ordination
Increase in alkaline phosphatase
Increase in serum transaminases
Irritability
Light-headedness
Metallic taste
Muscle weakness
Nausea
Nightmares
Paradoxical reactions
Paraesthesia
Pruritus
Rash
Respiratory depression
Restlessness
Sleep walking
Somnolence
Speech disturbances
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Urticaria
Vomiting
Withdrawal symptoms

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Zimovane 7.5mg film coated tablets. Sanofi. Revised July 2021.
Summary of Product Characteristics: Zimovane LS 3.75mg film-coated tablets. Sanofi. Revised July 2021.
Summary of Product Characteristics: Zopiclone 7.5mg tablets. Kent pharmaceuticals. Revised March 2016.
Summary of Product Characteristics: Zopiclone 3.75mg tablets. Generics UK TIA. Revised March 2016.
Summary of Product Characteristics: Zopiclone 3.75mg tablets. Mylan. Revised June 2018.
Summary of Product Characteristics: Zopiclone 7.5mg tablets. Mylan. Revised October 2015.
Summary of Product Characteristics: Zopiclone 3.75mg tablets. Accord. Revised August 2018.
Summary of Product Characteristics: Zopiclone 7.5mg tablets. Accord. Revised August 2018.
Summary of Product Characteristics: Zopiclone 3.75mg tablets. Teva UK. Revised September 2018.