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ROZEREM (RAMELTEON)
- Sleep-onset insomnia
8 mg tablet
- 1 tablet (8 mg) by oral route once daily at bedtime
8 mg tablet
- 1 tablet (8 mg) by oral route once daily at bedtime
Sleep-onset insomnia
- 1 tablet (8 mg) by oral route once daily at bedtime
- fluvoxamine
- Luvox Cr
Contraindicated
- None
Severe
Moderate
- None
- Severe hepatic disease
- Sleep apnea
Contraindicated
- Alcoholism
- Suicidal ideation
Severe
Moderate
- Complex sleep behavior
- Depression
- Disease of liver
- Hyperprolactinemia
ROZEREM (RAMELTEON)
- Sleep-onset insomnia
- None
- Dizziness
- Drowsy
- Fatigue
- Headache disorder
More Frequent
Severe
Less Severe
- Depression
- Arthralgias
- Diarrhea
- Dysgeusia
- Insomnia
- Myalgias
- Nausea
- Upper respiratory infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Amenorrhea
- Anaphylaxis
- Angioedema
- Behavioral disorders
- Dyspnea
- Galactorrhea not associated with childbirth
- Libido changes
Less Severe
- Acute confusion
- Ataxia
- Complex sleep behavior
- Hallucinations
Contraindicated
None
Severe Precaution
Ramelteon
Safety and efficacy not established in pubertal and pre-pubertal pediatrics.
- 1 Day – 16 Years
- Safety and efficacy not established in pubertal and pre-pubertal pediatrics.
Management or Monitoring Precaution
None
Ramelteon
- Severity Level:
2
- Additional Notes: Postmarket reports show no incr risk of major birth defects; dev tox in animals.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Ramelteon
Excreted in rat studies. caution advised
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Excreted in rat studies. caution advised |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Ramelteon
Neuro/Psych-Monitor for sleep automatisms and cognitive impairment.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Sleep-onset insomnia | |
| G47.00 | Insomnia, unspecified |
| 0-9 | A-Z |
|---|---|
| G47.00 | Insomnia, unspecified |
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