Ramelteon is a selective melatonin receptor agonist, primarily indicated for the treatment of insomnia characterized by difficulty falling asleep. In practical clinical application, its medication precautions and monitoring requirements must be strictly followed to enhance therapeutic efficacy and avoid potential risks.

Precautions for Ramelteon Administration

Absolute Contraindications

History of Allergy: Patients who have experienced angioedema (e.g., swelling of the tongue or throat) or anaphylactic shock after taking ramelteon are contraindicated from using the drug, and re-administration must not be attempted.

Contraindicated Drug Combinations: Fluvoxamine (a strong CYP1A2 inhibitor): Concomitant use can increase the plasma concentration of ramelteon by approximately 190 times and must be strictly avoided.

Alcohol: May exacerbate central nervous system depressant effects, leading to drowsiness or complex sleep behaviors (e.g., "sleep driving").

Dosage and Administration Standards

Standard Dosage: The recommended dose for adults is 8mg, taken within 30 minutes before bedtime, with a maximum daily dose not exceeding 8mg.

Dietary Impact: High-fat meals can delay drug absorption and reduce the peak plasma concentration; the drug should be taken on an empty stomach or 2 hours after a meal.

Patients with Hepatic Impairment

Mild Impairment: Use with caution, as drug exposure may increase by 4 times.

Moderate to Severe Impairment: Dose reduction and monitoring are required for patients with moderate impairment; use is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).

Respiratory Diseases

Sleep Apnea: Use is contraindicated in patients with moderate to severe sleep apnea due to insufficient safety data.

COPD Patients: No respiratory depression was observed after a single dose, but the long-term effects remain unclear.

Central Nervous System Effects

Complex Sleep Behaviors: These include unconscious eating, driving, or sexual activity; the drug must be discontinued immediately if such behaviors occur.

Psychiatric Symptoms: Prompt intervention is needed for hallucinations, worsening depression, or suicidal ideation.

Reduced Alertness the Next Day: Avoid driving or operating machinery after taking the drug.

Endocrine Effects

Long-term use may decrease testosterone levels and increase prolactin levels, manifesting as sexual dysfunction or menstrual irregularities. Regular monitoring of hormone levels is required.

Treatment Monitoring for Ramelteon

Efficacy Assessment

Short-Term Treatment: If insomnia does not improve within 7–10 days, re-evaluation is necessary to identify potential mental or physical underlying diseases.

Long-Term Follow-Up: Reassess sleep quality and behavioral changes every 3 months.

Laboratory Monitoring

Endocrine Indicators: Measure prolactin and testosterone levels in cases of unexplained amenorrhea, galactorrhea, or infertility.

Liver Function: Regularly monitor ALT/AST levels in patients with moderate to severe liver disease.