雷美替胺(Ramelteon)的用药注意事项

Ramelteon is a selective melatonin receptor agonist. It is recommended to use it under the guidance of a professional physician.

Ramelteon Medication Precautions

1. Adequate patient assessment

Sleep disorders may be a manifestation of certain physical and/or psychiatric diseases; patients should be carefully evaluated before symptomatic treatment. Failure of insomnia to resolve after an appropriate course of treatment, worsening of insomnia symptoms, and/or the development of new cognitive or behavioral abnormalities may indicate an underlying psychiatric or physical disorder that requires further evaluation.

2. Complex sleep-related behaviors

There is a potential risk of complex sleep-related behaviors, such as sleep driving (that is, driving while not fully awake after taking sedative-hypnotic drugs and having no memory of the event), making phone calls, or preparing and eating food while sleeping.

3. Anaphylaxis

There is a potential risk of allergic reaction and angioedema; it may occur after the first dose.

4. Psychological effects

Cognitive and behavioral changes have been reported. Following use, patients with predominant depression reported increased depression and suicidal ideation. Any new psychiatric disorder requires immediate evaluation.

5. Endocrine effects

If unexplained amenorrhea, galactorrhea, loss of libido, or fertility problems occur, evaluation of prolactin or testosterone concentrations should be considered.

6. Abuse potential and dependence

No evidence of abuse potential was detected after administration of doses up to 20 times the recommended hypnotic dose to patients with a history of drug abuse or dependence. No evidence of physical dependence was found.

7. Discontinuation reaction

No evidence of discontinuation syndrome (including rebound insomnia) was found after discontinuation of the drug after long-term treatment (4, 8 or 16 mg daily for up to 35 days).

8. Aftereffects

In adult patients receiving 8 mg of remelton daily, next-day residual effects (decreased immediate/delayed memory recall and increased sleepiness, fatigue, and irritability) were detected during weeks 1 and 3 of treatment, but not during week 5.

9. Long-term safety

No clinically significant changes were detected in laboratory parameters, endocrine tests, vital signs, electrocardiogram recordings, or menstrual bleeding intensity in patients with chronic insomnia after up to 1 year of treatment. No rebound insomnia was observed after 1 year of treatment.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Ramelteon (Ramelteon) medication for specific groups of people

1. Pregnancy

Pregnancy classification category C.

2. Lactation period

Ramelteon can be distributed into rat milk. It is unclear whether it will be distributed into human milk, and its use is not recommended.

3. Pediatric use

Safety and effectiveness have not been established in pediatric patients.

4. Medication in the elderly

Exposure to ramelteon and its active metabolites is increased, and no overall differences in safety or efficacy were observed compared with younger adults.

5. Hepatic insufficiency

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

Ramelteon drug interactions

1. CYP1A2 inhibitors

There may be pharmacokinetic interactions (significantly increasing the serum concentration of ramelteon). Avoid concurrent use with strong CYP1A2 inhibitors; use caution if used concurrently with less potent CYP1A2 inhibitors.

2. CYP3A4 and CYP2C9 inhibitors

There may be a pharmacokinetic interaction (increased serum concentrations of ramelton and its active metabolites), caution should be exercised if used concomitantly with strong CYP3A4 or CYP2C9 inhibitors.

3. CYP isoenzyme inducers

There may be pharmacokinetic interactions (lowering the serum concentration of ramelton and its active metabolites). The efficacy of ramelteon may be reduced when used concomitantly with strong CYP inducers.