VIDAL pharmacotherapeutic classification:

Psychiatry > Hypnotics > Benzodiazepines and related drugs ( Zopiclone )
ATC classification:


Example of Substance

dicalcium phosphate , sodium carboxymethyl starch , magnesium stearatefilm coating:  opadry , hypromellose , macrogol 6000

colorant (film coating):  titanium dioxide

Examples with known effect :
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Wheat starch (containing gluten):
This medicine contains very low gluten (from wheat starch) and is therefore unlikely to cause problems with celiac disease.
A 3.75 mg tablet does not contain more than 3 micrograms of gluten.
A 7.5 mg tablet contains no more than 6.0 micrograms of gluten.
Patients with wheat allergy (different from celiac disease), should not take this medication ( see Contraindications ).
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium free’.
Pharmacological tolerance:
The sedative or hypnotic effect of benzodiazepines and related drugs may gradually diminish despite the use of the same dose when administered for several weeks.
No significant tolerance was observed with Imovane film-coated tablets and scored film-coated tablets, for treatment durations of up to 4 weeks.
Addiction :
Any treatment with zopiclone can lead to the development of abuse and/or a state of physical and psychological drug dependence.
The risk of dependence increases with the dose and duration of treatment. The risk of abuse and dependence is higher in patients with a history of psychiatric disorders and/or alcoholism, drug addiction and drug abuse. Zopiclone should be prescribed with extreme caution in patients with or with a history of abuse or dependence on alcohol, drugs or medication.
Drug dependence may occur at therapeutic doses and/or in patients without individualized risk factors.
With zopiclone, this state of drug dependence has been reported exceptionally at therapeutic doses.
If physical dependence sets in, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms, which may be headache, muscle aches, significant anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may appear: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Withdrawal symptoms may occur within days of stopping treatment. For short-acting benzodiazepines, and especially if they are given in high doses, symptoms can even appear in the interval between two doses.
The combination of several benzodiazepines risks, whatever the indication, anxiolytic or hypnotic, to increase the risk of drug dependence.
Cases of abuse have been reported.


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