Short term treatment of insomnia in adults, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended.

Why have I been prescribed Zimovane?

Short term treatment of insomnia in adults, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended.

Whats the dose?

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

Adults

The recommended dose is one Zimovane tablet (7.5mg zopiclone) by the oral route shortly before retiring.

Elderly patients

A lower dose of 3.75mg zopiclone should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary.

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.

Patients with hepatic insufficiency

As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75mg zopiclone nightly is recommended.

The standard dose of 7.5mg 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. However, it is recommended that patients with impaired renal function should start treatment with 3.75mg.

Chronic respiratory insufficiency

In patients with chronic respiratory insufficiency, a starting dose of 3.75 mg zopiclone is recommended initially. The dosage subsequently may be increased to 7.5 mg.

Treatment duration

Transient insomnia 2 - 5 days.

Short term insomnia 2 - 3 weeks.

A single course of treatment should not continue for longer than 4 weeks including any tapering off. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient's status.

The product should be taken just before retiring for the night.

Contraindications

Zimovane is contraindicated in patients with:

  • Myasthenia gravis
  • Respiratory failure
  • Severe sleep apnoea syndrome
  • Severe hepatic insufficiency
  • Hypersensitivity to zopiclone or to any of the excipients.

As with all hypnotics Zimovane should not be used in children.

Side effects

Immune system disorders

Psychiatric disorders

  • Uncommon: nightmare, agitation
  • Rare: confusional state, libido disorder, irritability, aggression, hallucination
  • Not known: restlessness, delusion, anger, depressed mood, abnormal behaviour (possibly associated with amnesia) and somnambulism (somnambulism and associated behaviour), dependence, withdrawal syndrome

Nervous system disorders

  • Common: dysgeusia (Bitter taste), somnolence (residual)
  • Uncommon: dizziness, headache
  • Rare: anterograde amnesia
  • Not known: ataxia, paraesthesia, cognitive disorders such as memory impairment, disturbance in attention, speech disorder

Eye disorders

  • Not known: diplopia

Respiratory, thoracic and mediastinal disorders

  • Rare: dyspnoea 
  • Not known: respiratory depression 

Gastrointestinal disorders

  • Common: dry mouth
  • Uncommon: nausea, vomiting
  • Not known: dyspepsia

Hepatobiliary disorders

  • Very rare: transaminases increased and/or blood alkaline phosphatase increased (mild to moderate)

Skin and subcutaneous tissue disorders

  • Rare: urticaria or rash, pruritus

Musculoskeletal and connective tissue disorders

  • Not known: muscular weakness

General disorders and administration site conditions

  • Uncommonfatigue
  • Not known: light headedness, incoordination

Withdrawal syndrome has been reported upon discontinuation of zopiclone. Withdrawal symptoms vary and may include rebound insomnia, muscle pain, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations. In very rare cases, seizures may occur.

Could it interact with other tablets?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you use this medicine. 

The sedative effect of this medicine will be increased if it is taken with any of the following, which can also cause drowsiness:

  • alcohol
  • antiepileptics, eg sodium valproate
  • antipsychotics, eg chlorpromazine, haloperidol, baclofen
  • barbiturates, eg phenobarbital, amobarbital
  • benzodiazepines, eg diazepam, temazepam
  • MAOI antidepressants, eg phenelzine
  • other sleeping tablets
  • sedating antihistamines, eg chlorphenamine, hydroxyzine, promethazine
  • strong opioid painkillers, eg morphine, codeine
  • tricyclic and related antidepressants eg amitriptyline, mirtazapine.

The following medicines may increase the amount of zopiclone in your blood and this could increase its sedative effect, as well as increase the risk of its side effects. As a result your doctor may need to prescribe a lower dose of zopiclone if you are taking any of these:

The following medicines may decrease the amount of drug in your blood and so could make it less effective. As a result your doctor may need to prescribe you a higher than normal dose of zopiclone if you are taking any of these:

If zopiclone is used with strong opioid painkillers, such as morphine, this can result in an increase in the euphoric effect that these painkillers can have. This could lead to an increased risk of psychological dependence on the painkiller.

What if I'm pregnant/Breastfeeding?

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of this medicine for use during pregnancy has not been established. The manufacturer recommends that it is not used during pregnancy. This is particularly important during the third trimester of pregnancy and during labour. Regular use of this medicine during the latter stages of pregnancy can cause withdrawal symptoms in the baby. Seek further medical advice from your doctor.
  • If you suspect that you could be pregnant or are planning a pregnancy while taking this medicine, you should speak to your doctor about stopping treatment.
  • Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant. Seek medical advice from your doctor.

 

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.netdoctor.co.uk/medicines/brain-and-nervous-system/a7792/zimovane-zopiclone/

https://www.hpra.ie/img/uploaded/swedocuments/2156968.PA1332_007_001.d0e2fdb1-c326-454d-a582-21daff3560fe.000001Zimovane%20PIL.150223.pdf

http://www.medicines.org.uk/emc/medicine/27165/SPC/Zimovane+7.5mg+film-coated+tablets

http://xpil.medicines.org.uk/ViewPil.aspx?DocID=3135

http://patient.info/forums/discuss/i-have-recently-been-prescribed-zimovane-7-5mg-and-have--2046

 

 

 

Health Reference: Insomnia