Description
Meladapt Pharmacodynamics
Melatonin is a synthetic analog of the pineal hormone (epiphysis), has adaptogenic, sedative, hypnotic effect. Normalizes circadian rhythms. Increases the concentration of gamma-aminobutyric acid (GABA) and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxal kinase, involved in the synthesis of GABA, dopamine and serotonin. Regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature, has a positive effect on the intellectual and mental functions of the brain, and on the emotional-personal sphere. Facilitates organization of the biological rhythm and normalization of night sleep. Improves sleep quality, speeds up falling asleep, regulates neuroendocrine functions. Adapts the organism of weather-sensitive people to changes in weather conditions.
Indications
In disorders of sleep, including those due to the violation of the rhythm of “sleep-wake”, such as desynchronosis (rapid change of time zones).
Contraindications
Hypersensitivity to melatonin and other drug components, severe renal disorders (creatinine clearance less than 30 ml/min), autoimmune diseases (no clinical data available), liver failure, pregnancy and lactation, age less than 18 years (effectiveness and safety have not been established).
Caution
Renal failure (CKG more than 30 ml/min), old age.
Administration during pregnancy and breast-feeding
Pregnancy
There are no data concerning the effect of melatonin on pregnancy.
It is not recommended to use Meladapt during pregnancy and in women planning to become pregnant.
Breast-feeding period
Because endogenous melatonin is detected in breast milk, exogenous melatonin may also penetrate into breast milk.
If it is necessary to use Meladapt during lactation, breast feeding should be stopped.
Dosage and administration
- Take orally.
- In case of sleep disturbance take 1 tablet (3 mg) 30-40 minutes before sleep, once a day.
- If desynchronosis as an adaptogen when changing time zones – 1 day before the flight and the next 2-5 days – 1 tablet 30-40 minutes before sleep.
- The maximum daily dose is 2 tablets (6 mg).
- Administration in special groups of patients
Older patients (over 65 years). - Melatonin metabolism decreases with age and this must be taken into consideration when choosing the dosage regimen for elderly patients.
- Taking this into account Meladapt can be taken 60-90 minutes before sleep in elderly patients.
- Renal dysfunction
It is not known about the effect of different degrees of renal dysfunction on the pharmacokinetics of melatonin, therefore the drug Meladapt should be used with caution in patients with mild to moderate renal failure. The drug is contraindicated in patients with severe renal insufficiency (CKR less than 30 ml/min) (see section “Contraindications”).
