Ramelteon

What is Ramelteon

Ramelteon is a selective melatonin receptor agonist used for the treatment of chronic or transient insomnia characterized by difficulty with sleep onset, targeting specific melatonin receptors which are believed to be involved in the regulation of the circadian rhythm.

In contrast to traditional hypnotics such as benzodiazepines which have abuse potential and may cause next-day impairment, ramelteon does not appear to have abuse potential and available data have shown no consistent evidence of next-day residual impairment.

Similar to other sedatives, ramelteon has been associated with sleep-related behaviors such as engaging in activities of daily living while not fully awake and having no memory of the event.

The use of alcohol and other CNS depressants may increase the risk of these behaviors.

Through a systematic review and using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) process, the task force of the American Academy of Sleep Medicine found that there is weak evidence of efficacy of ramelteon in the treatment of sleep onset insomnia, with limited or no consistent evidence of adverse events in excess of placebo.

Therefore, the benefits were deemed to marginally outweigh harms. The task force further determined that due to the efficacy of ramelteon for sleep onset and its relatively benign side effect profile, a majority of patients would be likely to use ramelteon compared to no treatment.

Ramelteon was approved by the FDA in 2005 for the treatment of insomnia.

Brand Name

Rozerem

Indications & Dosage

  • insomnia

For the treatment of chronic or transient insomnia characterized by difficulty with sleep onset

Side Effects

  1. adrenocortical insufficiency
  2. agitation
  3. anaphylactoid reactions
  4. angioedema
  5. complex sleep-related behaviors
  6. depression
  7. dizziness
  8. drowsiness
  9. fatigue
  10. hallucinations
  11. headache
  12. hepatitis
  13. hyperprolactinemia
  14. insomnia
  15. mania
  16. nausea
  17. somnambulism
  18. suicidal ideation
  • adrenocortical insufficiency
  • agitation
  • anaphylactoid reactions
  • angioedema
  • complex sleep-related behaviors
  • depression
  • dizziness
  • drowsiness
  • fatigue
  • hallucinations
  • headache
  • hepatitis
  • hyperprolactinemia
  • insomnia
  • mania
  • nausea
  • somnambulism
  • suicidal ideation

Interactions

  • Acetaminophen; Aspirin, ASA; Caffeine
  • Acetaminophen; Butalbital; Caffeine
  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Caffeine
  • Acetaminophen; Caffeine; Dihydrocodeine
  • Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
  • Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
  • Acetaminophen; Codeine
  • Acetaminophen; Hydrocodone
  • Acetaminophen; Oxycodone
  • Acetaminophen; Tramadol
  • Alfentanil
  • Alprazolam
  • Amiodarone
  • Amitriptyline; Chlordiazepoxide
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Anxiolytics; Sedatives; and Hypnotics
  • Apraclonidine
  • Aprepitant, Fosaprepitant
  • Aripiprazole
  • Asenapine
  • Aspirin, ASA; Butalbital; Caffeine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Caffeine; Orphenadrine
  • Aspirin, ASA; Carisoprodol; Codeine
  • Aspirin, ASA; Oxycodone
  • Atazanavir; Cobicistat
  • Barbiturates
  • Belladonna; Opium
  • Benzhydrocodone; Acetaminophen
  • Benzodiazepines
  • Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
  • Bismuth Subsalicylate; Metronidazole; Tetracycline
  • Boceprevir
  • Brompheniramine; Guaifenesin; Hydrocodone
  • Brompheniramine; Hydrocodone; Pseudoephedrine
  • Buprenorphine
  • Buprenorphine; Naloxone
  • Buspirone
  • Cabergoline
  • Caffeine
  • Caffeine; Ergotamine
  • Cannabidiol
  • Carbamazepine
  • Carbinoxamine; Hydrocodone; Phenylephrine
  • Carbinoxamine; Hydrocodone; Pseudoephedrine
  • Cariprazine
  • Cenobamate
  • Ceritinib
  • Cetirizine
  • Cetirizine; Pseudoephedrine
  • Chloral Hydrate
  • Chloramphenicol
  • Chlordiazepoxide
  • Chlordiazepoxide; Clidinium
  • Chlorpheniramine; Codeine
  • Chlorpheniramine; Dihydrocodeine; Phenylephrine
  • Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
  • Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
  • Chlorpheniramine; Hydrocodone
  • Chlorpheniramine; Hydrocodone; Phenylephrine
  • Chlorpheniramine; Hydrocodone; Pseudoephedrine
  • Cimetidine
  • Ciprofloxacin
  • Clarithromycin
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Codeine
  • Codeine; Guaifenesin
  • Codeine; Phenylephrine; Promethazine
  • Codeine; Promethazine
  • COMT inhibitors
  • Conivaptan
  • Cyclobenzaprine
  • Cyclosporine
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Delavirdine
  • Deutetrabenazine
  • Diazepam
  • Dihydrocodeine; Guaifenesin; Pseudoephedrine
  • Diltiazem
  • Diphenhydramine; Hydrocodone; Phenylephrine
  • Disulfiram
  • Donepezil
  • Donepezil; Memantine
  • Doxepin
  • Dronedarone
  • Droperidol
  • Drospirenone; Ethinyl Estradiol
  • Drospirenone; Ethinyl Estradiol; Levomefolate
  • Elbasvir; Grazoprevir
  • Elexacaftor; tezacaftor; ivacaftor
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Enzalutamide
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Esketamine
  • Estazolam
  • Eszopiclone
  • Ethanol
  • Ethinyl Estradiol
  • Ethinyl Estradiol; Desogestrel
  • Ethinyl Estradiol; Ethynodiol Diacetate
  • Ethinyl Estradiol; Etonogestrel
  • Ethinyl Estradiol; Levonorgestrel
  • Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
  • Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
  • Ethinyl Estradiol; Norelgestromin
  • Ethinyl Estradiol; Norethindrone
  • Ethinyl Estradiol; Norethindrone Acetate
  • Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
  • Ethinyl Estradiol; Norethindrone; Ferrous fumarate
  • Ethinyl Estradiol; Norgestimate
  • Ethinyl Estradiol; Norgestrel
  • Fenofibric Acid
  • Fentanyl
  • Fluconazole
  • Fluorouracil, 5-FU
  • Fluoxetine; Olanzapine
  • Flurazepam
  • Fluvoxamine
  • food
  • Gabapentin
  • Givosiran
  • Goserelin
  • grapefruit juice
  • Guaifenesin; Hydrocodone
  • Guaifenesin; Hydrocodone; Pseudoephedrine
  • Haloperidol
  • Histrelin
  • Homatropine; Hydrocodone
  • Hydrocodone
  • Hydrocodone; Ibuprofen
  • Hydrocodone; Phenylephrine
  • Hydrocodone; Potassium Guaiacolsulfonate
  • Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
  • Hydrocodone; Pseudoephedrine
  • Hydromorphone
  • Ibuprofen; Oxycodone
  • Idelalisib
  • Imatinib
  • Isavuconazonium
  • Isocarboxazid
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Itraconazole
  • Ivacaftor
  • Ketoconazole
  • Lasmiditan
  • Leflunomide
  • Lemborexant
  • Letermovir
  • Leuprolide
  • Leuprolide; Norethindrone
  • Levocetirizine
  • Levorphanol
  • Lithium
  • Lofexidine
  • Lorazepam
  • Lumacaftor; Ivacaftor
  • Lumacaftor; Ivacaftor
  • Lumateperone
  • Lurasidone
  • Melatonin
  • Meperidine
  • Meperidine; Promethazine
  • Meprobamate
  • Methadone
  • Metoclopramide
  • Metronidazole
  • Mexiletine
  • Midazolam
  • Mifepristone
  • Mitotane
  • Monoamine oxidase inhibitors
  • Morphine
  • Morphine; Naltrexone
  • Nabilone
  • Norfloxacin
  • Obeticholic Acid
  • Olanzapine
  • Omeprazole; Amoxicillin; Rifabutin
  • Oritavancin
  • Osilodrostat
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pazopanib
  • Perampanel
  • Phenelzine
  • Phenicol Derivatives
  • Phentermine; Topiramate
  • Posaconazole
  • Pregabalin
  • Protease inhibitors
  • Quazepam
  • Rasagiline
  • Remifentanil
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifampin
  • Rotigotine
  • Rucaparib
  • Safinamide
  • Sedating H1-blockers
  • Segesterone Acetate; Ethinyl Estradiol
  • Selegiline
  • Simeprevir
  • Sufentanil
  • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
  • Sulfinpyrazone
  • Suvorexant
  • Tacrine
  • Tapentadol
  • Tasimelteon
  • Telaprevir
  • Telithromycin
  • Telotristat Ethyl
  • Temazepam
  • Tezacaftor; Ivacaftor
  • Thalidomide
  • Thiabendazole
  • Tizanidine
  • tobacco
  • Topiramate
  • Tramadol
  • Trandolapril; Verapamil
  • Tranylcypromine
  • Trazodone
  • Triazolam
  • Triptorelin
  • Tucatinib
  • Valerian, Valeriana officinalis
  • Vemurafenib
  • Verapamil
  • Vigabatrin
  • Vilazodone
  • Voriconazole
  • Zafirlukast
  • Zaleplon
  • Zileuton
  • Zolpidem
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