Ramelta tablet is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Ramelteon is a melatonin (MT) receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and selectivity over the MT3 receptor. The activity of Ramelteon at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind to neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine and opiates.
Adults : One tablet (8 mg) taken within 30 minutes of going to bed. It should not be taken with or immediately after a high-fat meal. Total daily dose should not exceed 8 mg. Elderly : No overall differences in safety and efficacy between elderly and younger adult subjects. Children : Safety and effectiveness not established.
Most common adverse reactions are somnolence, dizziness, fatigue, nausea, headache, and exacerbated insomnia. Hallucinations, behavioral changes such as bizarre behavior, agitation and mania have been reported with Ramelta use. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
Hypersensitivity to any of the ingredients of this formulation.
Rifampin: Decreases exposure to and effects of Ramelta. Ketoconazole: Increases AUC for Ramelta. Fluconazole: Increases systemic exposure of Ramelta. Donepezil: Increases systemic exposure of Ramelta. Doxepin: Increases systemic exposure of Ramelta.
There may be a chance of occurrence of angioedema, anaphylaxis, hallucinations, decreased testosterone level and increased prolactine level.