RAMELTEON
THERAPEUTICS
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
SIDE EFFECTS
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
DOSING AND USE
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
SPECIAL POPULATIONS
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
Based on data Published online by Cambridge University Press
Compiled by Dr. Jash Ajmera