• Insomnia characterized by difficult sleep onset.

Contraindicated in:

• Hypersensitivity
• History of angioedema with previous use
• Severe hepatic impairment
• Concurrent use of fluvoxamine.

Use Cautiously in:

• Depression or history of suicidal ideation
• Moderate hepatic impairment
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk of somnolence in infant
• Pedi: Safety and effectiveness not established in children.

Endo: ↑prolactin levels, ↓ testosterone levels.

GI: nausea.

Neuro: abnormal thinking, behavior changes, dizziness, fatigue, hallucinations, headache, insomnia (worsened), sleep-driving.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Fluvoxamine may ↑ levels and risk of toxicity; concurrent use is contraindicated.
• Rifampin may ↓ levels and effectiveness.
• Concurrent use of CYP3A4 inhibitors, including ketoconazole, may ↑ levels and risk of toxicity; use cautiously.
• Concurrent use of CYP2C9 inhibitors, including fluconazole, may ↑ levels and risk of toxicity; use cautiously.
• Donepezil and doxepin may ↑ levels.
• ↑risk of excessive CNS depression with other CNS depressants including alcohol, benzodiazepines, opioids, and other sedative/hypnotics.

(Generic available)

• Tablets: 8 mg;

• PO (Adults): 8 mg within 30 min of going to bed.

Rozerem

• Activates melatonin receptors, which promotes maintenance of circadian rhythm, a part of the sleep-wake cycle.

• Easier onset of sleep.

Therapeutic Classification: sedative/hypnotics

Pharmacologic Classification: melatonin receptor agonists

Absorption: Well absorbed (84%), but bioavailability is low (1.8%) due to extensive first pass liver metabolism. Absorption ↑ by a high-fat meal.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Extensively metabolized by the liver primarily by the CYP1A2 isoenzyme and to a lesser extent by the CYP2C9 and CYP3A4 isoenzymes. Metabolites are excreted mostly in urine (88%); 4% excreted in feces.

Half-life: 1–2.6 hr.

(plasma concentrations)

• 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.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

ra-MEL-tee-on

NDC Code^*

• 0591- Actavis Pharma, Inc.
  • 0591-2191- Ramelteon
    • 0591-2191-01- 100 TABLET in 1 BOTTLE (0591-2191-01)

• 0591- Actavis Pharma, Inc.
  • 0591-2191- Ramelteon
    • 0591-2191-30- 30 TABLET in 1 BOTTLE (0591-2191-30)

• 43598- Dr.Reddys Laboratories Inc
  • 43598-741- Ramelteon
    • 43598-741-01- 100 TABLET in 1 BOTTLE (43598-741-01)

• 43598- Dr.Reddys Laboratories Inc
  • 43598-741- Ramelteon
    • 43598-741-10- 1000 TABLET in 1 BOTTLE (43598-741-10)

• 43598- Dr.Reddys Laboratories Inc
  • 43598-741- Ramelteon
    • 43598-741-30- 30 TABLET in 1 BOTTLE (43598-741-30)

• 63629- Bryant Ranch Prepack
  • 63629-8264- Ramelteon
    • 63629-8264-1- 30 TABLET in 1 BOTTLE (63629-8264-1)

• 64764- Takeda Pharmaceuticals America, Inc.
  • 64764-805- Rozerem
    • 64764-805-10- 100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)

• 64764- Takeda Pharmaceuticals America, Inc.
  • 64764-805- Rozerem
    • 64764-805-22- 6 CARTON in 1 TRAY (64764-805-22) > 1 BLISTER PACK in 1 CARTON > 2 TABLET, FILM COATED in 1 BLISTER PACK

• 64764- Takeda Pharmaceuticals America, Inc.
  • 64764-805- Rozerem
    • 64764-805-30- 30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)

• 70710- Zydus Pharmaceuticals (USA) Inc.
  • 70710-1344- Ramelteon
    • 70710-1344-1- 100 TABLET in 1 BOTTLE (70710-1344-1)

• 70710- Zydus Pharmaceuticals (USA) Inc.
  • 70710-1344- Ramelteon
    • 70710-1344-3- 30 TABLET in 1 BOTTLE (70710-1344-3)

• 70710- Zydus Pharmaceuticals (USA) Inc.
  • 70710-1344- Ramelteon
    • 70710-1344-5- 500 TABLET in 1 BOTTLE (70710-1344-5)

• 70771- Cadila Healthcare Limited
  • 70771-1495- Ramelteon
    • 70771-1495-1- 100 TABLET in 1 BOTTLE (70771-1495-1)

• 70771- Cadila Healthcare Limited
  • 70771-1495- Ramelteon
    • 70771-1495-3- 30 TABLET in 1 BOTTLE (70771-1495-3)

• 70771- Cadila Healthcare Limited
  • 70771-1495- Ramelteon
    • 70771-1495-5- 500 TABLET in 1 BOTTLE (70771-1495-5)