Pharmacologic class: Melatonin receptor agonist
Therapeutic class: Hypnotic
Pregnancy risk category C
Promotes sleep through activity at melatonin MT1 and MT2 receptors, which are thought to be involved in maintaining circadian rhythm underlying normal sleep-wake cycle
Tablets: 8 mg
Indications and dosages
➣ Insomnia marked by difficulty with sleep onset
Adults: 8 mg P.O. within 30 minutes of going to bed
• Hypersensitivity to drug or its components
Use cautiously in:
• sleep apnea, chronic obstructive pulmonary disease, hepatic impairment
• concurrent use of fluvoxamine
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Give within 30 minutes of patient's bedtime.
• Don't give with or immediately after a high-fat meal.
CNS: headache, somnolence, fatigue, dizziness, exacerbated insomnia, depression
GI: nausea, diarrhea
Musculoskeletal: myalgia, arthralgia
Respiratory: upper respiratory tract infection
Other: altered taste, influenza
Drug-drug. Fluconazole, fluvoxamine, ketoconazole: increased ramelteon blood level
Rifampin: decreased ramelteon efficacy
Drug-diagnostic tests. Blood cortisol: decreased
Drug-food. High-fat meals: altered ramelteon absorption
Drug-herbs. American elder, bishop's weed, cat's claw, devil's claw, eucalyptus, feverfew, ginkgo, kava, licorice, pomegranate: increased ramelteon blood level
Valerian: additive sedation, increased ramelteon blood level
Drug-behaviors. Alcohol use: additive psychomotor impairment
• Monitor prolactin and testosterone levels, if ordered, in patient who develops unexplained amenorrhea, galactorrhea, decreased libido, or fertility problems.
• Evaluate patient for physical and psychiatric disorders before and during therapy. Worsening of insomnia or onset of new behavioral or cognitive symptoms could signal underlying psychiatric disorder.
• Instruct patient to take drug within 30 minutes of going to bed.
• Advise patient not to take drug with or immediately after a high-fat meal.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• Advise patient to contact prescriber if insomnia worsens.
• Instruct patient to report menses cessation, excessive or spontaneous lactation, decreased libido, or fertility problems.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, food, herbs, and behaviors mentioned above.
ClassificationTherapeutic: sedative hypnotics
Pharmacologic: melatonin receptor agonists
Time/action profile (blood levels)
Adverse Reactions/Side Effects
Central nervous system
- abnormal thinking
- behavior changes
- insomnia (worsened)
- ↑ prolactin levels
- ↓ testosterone levels
- angioedema (life-threatening)
Drug-Drug interactionBlood levels and effects are ↑ by fluvoxamine ; concurrent use is contraindicated.Levels and effects may be ↓ by rifampin.Concurrent use of CYP3A4 inhibitors, such as ketoconazole, may ↑ levels and effects; use cautiously.Concurrent use of CYP2C9 inhibitors, such as fluconazole, may ↑ levels and effects; use cautiously.Donepezil and doxepin may ↑ levels.↑ risk of excessive CNS depression with other CNS depressants including alcohol, benzodiazepines, opioids, and other sedative/hypnotics.
Availability (generic available)
- Assess sleep patterns before and periodically throughout therapy.
Potential Nursing Diagnoses(Indications)
Risk for injury (Side Effects)
- Do not confuse Rozerem (ramelteon) with Razadyne (galantamine).
- Do not administer with or immediately after a high-fat meal.
- Before administering, reduce external stimuli and provide comfort measures to increase effectiveness of medication.
- Oral: Administer 30 min prior to going to bed.
- Instruct patient to take ramelteon as directed, within 30 min of going to bed and to confine activities to those necessary to prepare for bed. Instruct patient to read the Medication Guide before starting and with each Rx refill; changes may occur.
- Causes drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
- Caution patient that complex sleep-related behaviors (sleep-driving, making phone calls, preparing and eating food, having sex, sleep walking) may occur while asleep. Inform patient to notify health care professional if sleep-related behaviors (may include sleep-driving—driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event) occur.
- Advise patient to notify health care professional immediately if signs of anaphylaxis (swelling of the tongue or throat, trouble breathing, and nausea and vomiting) or angioedema (severe facial swelling) occur; may occur as early as the first time the product is taken.
- Caution patient to avoid concurrent use of alcohol or other CNS depressants.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Relief of insomnia.