Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Substrate of
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

North America

USA: Rozerem.

Drug combinations


Ramelteon: C~16~H~21~NO~2~. Mw: 259.34. (1) Propanamide, N-[2-[(8S)-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]-; (2)(-)-N-[2-([(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propanamide. CAS-196597-26-9 (2004).

Pharmacologic Category

Anxiolytics, Sedatives, and Hypnotics; Miscellaneous. Nonbenzodiazepine Hypnotic. (ATC-Code: N05CH02).

Mechanism of action

Potent, selective agonist of melatonin receptors MT~1~ and MT~2~ (with little affinity for MT~3~) within suprachiasmic nucleus of hypothalamus. Agonism of MT~1~ thought to preferentially induce sleepiness, while MT~2~ receptor activation preferentially influences regulation of circadian rhythms.

Therapeutic use

Treatment of insomnia characterized by difficulty with sleep onset.

Pregnancy and lactiation implications

Animal studies demonstrated teratogenic effects. May cause disturbances of reproductive hormonal regulation (e.g. disruption of menses or decreased libido). There are no adequate, well-controlled studies in pregnant women. Excretion in breast milk unknown (use with caution during lactation).

Unlabeled use


History of angioedema with previous ramelteon therapy. Concurrent use with fluvoxamine.

Warnings and precautions

Hypnotics/sedatives associated with abnormal thinking and behavior changes, including decreased inhibition, aggression, bizarre behavior, agitation, hallucinations, and depersonalization (may indicate previously unrecognized psychiatric disorders). May cause CNS depression. Use of hypnotic/sedative agents (including ramelteon) for sleep associated with hypersensitivity reactions including anaphylaxis as well as angioedema. Patients who developed angioedema with ramelteon therapy should not be rechallenged. Reproductive hormonal regulation disturbances may cause disturbances of reproductive hormonal regulation (e.g. disruption of menses or decreased libido). Increased risk for hazardous sleep-related activities such as sleep-driving, cooking and eating food, and making phone calls while asleep also noted. Use with caution in depression (worsening of depression, including suicidal ideation reported with use of hypnotics), in hepatic impairment (use not recommended with severe impairment), and in respiratory compromise, COPD or sleep apnea. Use with caution in patients receiving other CNS depressants or psychoactive medication (effects with other sedative drugs or ethanol may be potentiated), and when administered concomitantly with strong CYP1A2 inhibitors. Rapid onset of action.



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