Adult Dosing

Insomnia

• 8 mg PO within 30 minutes of going to bed; Max: 8 mg/day
• Avoid administration with high fat meal

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Insomnia characterized by difficulty with sleep onset

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with fluvoxamine
• Severe sleep apnea
• Severe hepatic impairment
• Angioedema, ramelteon associated

• N/A

Renal Dose Adjustment

• Renal impairement: No dose adjustments

Hepatic Dose Adjustment

• Mild to Moderate hepatic impairment: Caution advised. Dose adjustments not defined
• Severe hepatic impairment: Contraindicated

See Supplemental Patient Information

• Severe anaphylactic/anaphylactoid reactions viz angioedema have occurred in patients receiving ramelteon. Do not rechallenge such patients with the drug
• Failure of remission within 7-10 days may indicate presence of a primary psychiatric and/or medical illness that should be evaluated
• Abnormal thinking, behavioral changes, complex behaviors including sleep driving and hallucinations may occur. Use of alcohol and CNS depressants increase the risk for such behaviors. Discontinue drug if complex sleep behaviors occur
• Patients should avoid engaging in hazardous activities like operating a motor vehicle or heavy machinery
• Worsening of depression or suicidal thinking may occur. Monitor patients closely
• Ramelteon is not indicated in severe obstructive sleep apnea
• It may produce an effect on reproductive hormones in adults like decreased testosterone levels and increased prolactin levels
• Avoid consumption with a high fat meal

Cautions: Use cautiously in

• History of depression
• Suicidal ideation
• Mild to moderate hepatic impairment
• History of COPD
• Concurrent use of CYP3A4 inhibitors(eg ketoconazole)
• Concurrent use of CYP2C9 inhibitors(eg fluconazole)

Supplemental Patient Information

• Patients should be warned about the possibility of sleep-driving and complex behaviors, especially with concurrent use of the drug with alcohol or CNS depressants

Rozerem interacts with :

	Atazanavir
	Cetraxal
	Ciloxan
	Cimetidine
	Cipro
	Cipro IV
	Cipro XR
	Ciprofloxacin
	Cognex
	Enoxacin
	Fluvoxamine
	Luvox
	Luvox CR
	Mexiletine
	Mexitil
	Penetrex
	Proquin XR
	Reyataz
	Smoking
	Tacrine
	Tagamet
	Tagamet HB
	Zileuton
	Zyflo
	Zyflo CR

Pregnancy Category:C

Breastfeeding: Safety unknown. Caution advised while administering to a nursing woman.

• PSYCHIATRY: Suicidal ideation, depression, behavioral disturbances, hallucinations, complex sleep-related behavior
• CNS: Headache, dizziness, insomnia, somnolence
• HYPERSENSITIVITY: Severe anaphylactic and anaphylactoid reactions
• GI: Nausea, diarrhea, taste changes
• RESP: URI
• ENDO: Elevated prolactin levels, decreased testosterone, cortisol decrease
• MUSC: Fatigue, arthralgia, myalgia

• Sedative/hypnotic; binds to melatonin MT1 and MT2 receptors and induces sleep. These receptors are involved in maintenance of the circadian rhythm underlying the normal sleep-wake cycle
• Extensively metabolized by liver; CYP450: 1A2 (substrate), 2C (minor), 3A4 (minor)
• Renally excreted: 84% (<1% unchanged); feces: 4%
• Half-life: 1-2.6 hrs (parent drug); 2-5 hrs (metabolites)

US Trade Name(s)

• Rozerem

US Availability

ramelteon (generic)

• TABS: 8 mg

Rozerem

• TABS: 8 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Psychiatric

Anxiolytics/Sedatives/Hypnotics

Melatonin Receptor Agonists

Neurologic

Anxiolytics/Sedatives/Hypnotics

Melatonin Receptor Agonists

Pricing data from www.DrugStore.com in U.S.A.

• Rozerem 8 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
  30 mg = $176
  90 mg = $485.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Rozerem 8 MG Oral Tablet

Ingredient(s): Ramelteon

Imprint: TAK;RAM;8

Color(s): Orange

Shape: Round

Size (mm): 7.00

Score: 1

Inactive Ingredient(s): lactose monohydrate / starch, corn / hydroxypropyl cellulose / magnesium stearate / hypromellose / copovidone / titanium dioxide / ferric oxide yellow / polyethylene glycol 8000 / shellac / ferrosoferric oxide

Drug Label Author:
Physicians Total Care, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Rozerem 8 MG Oral Tablet

Ingredient(s): Ramelteon

Imprint: TAK;RAM;8

Color(s): Orange

Shape: Round

Size (mm): 7.00

Score: 1

Inactive Ingredient(s): lactose monohydrate / starch, corn / hydroxypropyl cellulose / magnesium stearate / hypromellose / copovidone / titanium dioxide / ferric oxide yellow / polyethylene glycol 8000 / shellac / ferrosoferric oxide

Drug Label Author:
Takeda Pharmaceuticals America, Inc.

DEA Schedule:
Non-Scheduled