Rozerem

Rozerem,

a trademark for ramelteon.

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ramelteon

Rozerem

Pharmacologic class: Melatonin receptor agonist

Therapeutic class: Hypnotic

Pregnancy risk category C

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug or its components

Precautions

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).

Administration

• Give within 30 minutes of patient's bedtime.
• Don't give with or immediately after a high-fat meal.

Route	Onset	Peak	Duration
P.O.	Unknown	0.5-1.5 hr	Unknown

Adverse reactions

CNS: headache, somnolence, fatigue, dizziness, exacerbated insomnia, depression

GI: nausea, diarrhea

Musculoskeletal: myalgia, arthralgia

Respiratory: upper respiratory tract infection

Other: altered taste, influenza

Interactions

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

Patient monitoring

• 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.

Patient teaching

• 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.