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IMOVANE (ZOPICLONE): SIDE EFFECTS, ADVERSE REACTIONS

The side-effects most commonly seen in clinical trials is taste alteration (bitter taste).

More Common Reactions

Gastrointestinal: dry mouth, bitter taste.

Nervous System: headaches, bitter taste, fatigue.

Less Common Reactions

Gastrointestinal: constipation, heartburn, diarrhoea, coated tongue, nausea, bad breath, vomiting, anorexia or increased appetite, epigastric pains, dyspepsia.

Cardiovascular: palpitations in elderly patients.

Skin: tingling, urticaria.

Reproductive: ejaculation failure, impotence, libido disorder.

Nervous System: anxiety, agitation, loss of memory including retrograde amnesia, confusion, anterograde amnesia, dizziness, somnolence, weakness, asthenia, feeling of drunkenness, depression, euphoria, co-ordination abnormality, speech disorder, hypotonia, hallucinations (auditory and visual), aggression, behavioural disorders, tremor, nightmares, rebound insomnia, irritability, sleep walking, inappropriate behaviour possibly associated with amnesia, restlessness, anger, delusion, ataxia, dependence.

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

Allergic or cutaneous: rash, pruritus. Angioedema and/or anaphylactic reactions have been reported very rarely while taking Zopiclone (Imovane).

Miscellaneous: micturition, blurred vision, mild to moderate increases in serum transaminases and/or alkaline phosphatase have been reported very rarely. Falls, predominantly in elderly patients, diplopia and muscular weakness have been reported.

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