Breast-feeding:

Zopiclone is excreted in breast milk and, although the concentration of Zopiclone in the breast milk is low, use in nursing mothers must be avoided.

4.7 Effects on ability to drive and use machines
Because of its pharmacological properties and its effect on central nervous system, Zopiclone may adversely affect the ability to drive or to use machines. The risk of psychomotor impairment, including impaired driving ability, is increased if:

• zopiclone is taken within 12 hours of performing activities that require mental alertness,

• a dose higher than the recommended dose is taken, or

• zopiclone is co-administered with other CNS depressants, alcohol, or with other drugs that increase the blood levels of zopiclone.

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.

4.8 Undesirable effects
The following CIOMS frequency rating is used, when applicable:

Very common (≥1/10); common (≥1/100 to ≥1/10); uncommon (≥1/1000 to <1/100 ); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot still be estimated from the available data).

Nervous system disorders
 
Common:
 dysgeusia (Bitter taste), somnolence (residual)
 
Uncommon:
 dizziness, headache and drowsiness have occurred.
 
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 (see section 4.4)
 
Not known:
 respiratory depression (see section 4.4)

Withdrawal Syndrome

Withdrawal syndrome has been reported upon discontinuation of zopiclone. (See section 4.4 Special Warnings and Precautions for Use.) 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.

Psychiatric disorders
 
Uncommon:
 nightmare (more likely to occur in the elderly), agitation
 
Rare:
 confusional state, libido disorder, irritability, aggression, hallucination (more likely to occur in the elderly),
 
Not known
 restlessness, delusion, anger, depressed mood, abnormal behaviour (possibly associated with amnesia) and somnambulism (see section 4.4: somnambulism and associated behaviour) dependence (see section 4.4), withdrawal syndrome (see below).
 
Gastrointes