Ramelta

Indications:

• Rameltai is primarily prescribed for the treatment of insomnia, particularly for those experiencing difficulties with falling asleep.

Consult a registered healthcare provider before using this medication.

Pharmacology:

• Ramelteon is a melatonin receptor agonist that binds with high affinity to MT1 and MT2 receptors. This interaction helps regulate sleep patterns, promoting sleep onset and supporting the body’s circadian rhythm. Unlike other sleep aids, Ramelteon does not affect GABA receptors or other neurotransmitter systems like serotonin or dopamine.

Dosage & Administration:

• Adults: 8 mg of Rameltai should be taken approximately 30 minutes before bedtime. It should not be consumed with or immediately after a high-fat meal. The recommended maximum dose is 8 mg per day.

Consult a registered healthcare provider before using this medication.

Drug Interactions:

• Rifampin (strong CYP enzyme inducer): May reduce the effectiveness of Rameltai.
• Ketoconazole (strong CYP3A4 inhibitor): May increase Rameltai levels, use with caution.
• Fluconazole and Doxepin: May elevate Rameltai levels; close monitoring is advised.
• Alcohol: May cause additive psychomotor impairment, avoid combining with alcohol.

Contraindications:

• Rameltai is contraindicated in patients with a history of angioedema while using the medication.
• Fluvoxamine (strong CYP1A2 inhibitor) should not be used alongside Rameltai.

Side Effects:

• Common side effects (occurring in 3% or more of patients) include somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

Pregnancy & Lactation:

• Pregnancy: Animal studies indicate potential fetal harm; use only if the benefits outweigh the risks.
• Lactation: Caution is advised when using Rameltai during breastfeeding.

Precautions & Warnings:

• Anaphylactic reactions such as angioedema and anaphylaxis have been reported; avoid re-exposure if these reactions occur.
• CNS effects: May impair alertness, avoid activities requiring mental focus (e.g., driving or operating machinery).
• Depression: Worsening depression or suicidal thoughts may occur.
• Severe sleep apnea: Not recommended for patients with severe sleep apnea.
• Reproductive effects: May decrease testosterone and increase prolactin levels.

Use in Special Populations:

• Pediatric Use: Safety and effectiveness are not established in patients under 18 years of age.
• Geriatric Use: No significant differences in safety or efficacy for older adults.
• Hepatic Impairment: Use with caution in patients with moderate hepatic impairment. Not recommended for those with severe impairment.

Therapeutic Class:

Miscellaneous sedatives & hypnotics.

Storage Conditions:

Store Rameltai at 25°C, with permissible excursions between 15°C to 30°C. Keep the container tightly closed and protect from moisture and humidity.