RAMELTEON

brands

Class

• Neuroscience-based Nomenclature: melatonin receptor agonist (Mel-RA)
• Melatonin 1 and 2 receptor agonist

RAMELTEON commonly prescribed for

(Bold for FDA approved)

How RAMELTEON works

• Binds selectively to melatonin 1 and melatonin 2 receptors as a full agonist

How long until RAMELTEON works

• Generally takes effect in less than an hour

Notable Side Effects

• Sedation

• Dizziness

• Fatigue

• Headache

Life Threatening Side Effects

• Respiratory depression, especially when taken with other CNS depressants in overdose

• Rare angioedema

weight gain

unusual

sedation

common

What to do about RAMELTEON side effects

• Wait

• To avoid problems with memory, only take ramelteon if planning to have a full night’s sleep

• Lower the dose

• Switch to a non-benzodiazepine sedative hypnotic

usual dosage range

• 8 mg at bedtime

Dosage Forms

• Tablet 8 mg

long term use

• No reports of dependence, tolerance, or abuse liability

• Not restricted to short-term use but few long-term studies

habit forming

• No

Renal Impairment

• Dose adjustment not generally necessary

Hepatic Impairment

• Use with caution in patients with moderate hepatic impairment

• Not recommended for use in patients with severe impairment

Cardiac Impairment

• Dosage adjustment may not be necessary

Elderly

• No adjustment necessary

• Greater absorption and higher plasma drug concentrations but no increase in side effects

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

Breast Feeding

• Unknown if ramelteon is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommended either to discontinue drug or bottle feed