The composition 1 tablets:
- active substance: zopiclone;
- 1 tablet contains zopiclone in terms of 100% substance 7.5 mg
- excipients: lactose monohydrate, potato starch; povidone, magnesium stearate.
Dosage form. Tablets
Basic physical and chemical properties: tablets of white color, flat-cylindrical shape with beveled and scored.
10 tablets in a blister, 1 or 2 blisters in a box.
Indications for use.
Hypnotics and sedatives. Severe sleep disorders: situational and temporary insomnia.
The drug should never be used in patients with:
- hypersensitivity to zopiclone or to any of the excipients of the drug;
- severe respiratory failure;
- sleep apnea syndrome;
- severe, acute, or chronic liver failure (due to the risk of encephalopathy);
- myasthenia gravis;
- allergy to wheat products (except for wheat intolerance for celiac disease).
Method of administration and dosage.
For oral administration.
Treatment should always be started with the lowest effective dose; the maximum dose must not be exceeded. The drug should be taken just before bedtime.
The 3.75 mg dose is intended specifically for elderly patients (over 65 years old) and those belonging to special risk groups.
Usual dosages for:
adults under the age of 65 – 7.5 mg per day
patients from 65 years old – 3.75 mg per day, a dose of 7.5 mg can be used only in exceptional cases;
patients with impaired liver function or chronic pulmonary insufficiency – the recommended dose is 3.75 mg per day (see section “Pharmacokinetics”);
patients with renal insufficiency – treatment should be started with a dose of 3.75 mg per day (see section “Pharmacokinetics”).
In all cases, the daily dose of Normason should not exceed 7.5 mg.
Duration of treatment.
Treatment should be as short-lived as possible. The duration of the course of treatment should not exceed 4 weeks, including the period of gradual discontinuation of treatment (see Section “Peculiarities of use”).
Patients should be advised to take the drug during:
– in case of situational insomnia – 2-5 days (for example, while traveling),
– in case of temporary insomnia – 2-3 weeks (eg caused by a serious event).
In some cases, it may be necessary to increase the recommended treatment period. In such a situation, the patient’s condition should be re-carefully evaluated.
The use of zopiclone in children has been investigated, therefore it is not recommended for this group of patients.