雷美替胺(Ramelteon)中文说明书:适应症、用法用量、不良反应、注意事项

Ramelteon is a selective MT1/MT2 melatonin receptor agonist developed by Takeda Pharmaceuticals. It was approved by the FDA in 2005 for the treatment of insomnia. It regulates the sleep cycle by simulating melatonin, and has the characteristics of rapid absorption and short half-life.

Indications of Ramelteon

Insomnia

Management of insomnia characterized by difficulty falling asleep. Reduce sleep latency in patients with transient insomnia. Reduced sleep latency in patients with chronic insomnia treated for up to 35 days.

Recommended dose of Ramelteon

1. Recommended dose for adults

Take 8 mg orally daily, and the maximum daily dose should not exceed 8 mg

2. Medication management

Take it orally within 30 minutes before bedtime, and avoid taking it during or immediately after a high-fat meal, because the absorption rate may be reduced.

Due to limited space, please refer to the original instructions of the drug for details. Please follow the guidance of your doctor for specific medication.

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Ramelteon (Ramelteon) adverse reactions

Common adverse reactions

Headache, drowsiness, dizziness, fatigue, nausea, worsening insomnia, upper respiratory tract infection, diarrhea, myalgia, depression, dysgeusia, joint pain.

Due to limited space, please refer to the original instructions of the drug for details. Please follow the guidance of your doctor for specific medication.

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Ramelteon (Ramelteon) Precautions

1. Patient evaluation ‌

Sleep disorders may be manifestations of physical or mental diseases, and patients need to be carefully evaluated before symptom treatment. If insomnia does not resolve, worsens, or develops new cognitive/behavioral abnormalities after a reasonable course of treatment, further evaluation of the underlying disease is required.

2. Complex sleep-related behaviors‌

Ramelteon may cause complex behaviors (such as sleep driving, unconscious phone calls or eating), and no memory afterwards.

3. Allergic reaction‌

Ramelteon may cause anaphylactic shock or angioedema, even after the first use of the drug.

4. Mental impact‌

Ramelteon may cause cognitive and behavioral changes, and patients with depression may experience worsening of depression or suicidal ideation. New onset psychosis requires immediate evaluation.

5. Endocrine effects‌

Long-term use of ramelteon (6 months, 16mg/day) may increase prolactin levels. Case reports indicate that long-term treatment (12 months) may lead to morning cortisol abnormalities or prolactinoma (causal relationship is not clear). If amenorrhea, galactorrhea, loss of libido, or infertility occur, it is recommended to test prolactin or testosterone levels.

6. Abuse and dependence‌

No abuse tendency has been found even at excessive doses (20 times the recommended dose), and there is no evidence of physical dependence.

7. Drug withdrawal reaction‌

(1) No withdrawal symptoms or rebound insomnia were observed after drug withdrawal after long-term treatment (35 days).

(2) Contraindications of Ramelteon

(3) Allergic to ramelteon or any ingredient in the formula.

Ramelteon (Ramelteon) Special Populations

1. Pregnancy

Animal experiments have confirmed that it is harmful to the fetus, but there is a lack of sufficient human clinical research data. Its use can only be considered when the benefits to pregnant women clearly outweigh the risks to the fetus.

2. Lactation

Distributed in rat milk; it is unknown whether it is distributed in human milk. Not recommended.

3. Pediatric use

The safety and effectiveness have not been determined in pediatric patients.

4. For the elderly

Increased exposure to drugs and active metabolites. However, there was no overall difference in safety or effectiveness compared with younger adults.

5. Hepatic impairment

Use with caution in patients with moderate hepatic insufficiency; avoid use in patients with severe hepatic insufficiency.