Methadone
Methadone, Methadose (methadone) is a small molecule pharmaceutical. Methadone was first approved as Dolophine hydrochloride on 1982-01-01. It is used to treat intractable pain and opioid-related disorders in the USA. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target kappa-type opioid receptor and delta-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Methadone, Methadose (discontinued: Dolophine, Methadone, Methadose, Westadone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| diskets | New Drug Application | 2023-12-01 |
| diskets dispersible | 2007-08-03 | |
| methadone | 2007-10-06 | |
| methadone hcl | 2008-05-08 | |
| methadone hydrochloride | ANDA | 2024-10-31 |
| methadone hydrochloride methadose | 2006-09-19 | |
| methadone hydrochloride methadose dispersible | ANDA | 2024-06-28 |
| methadone hydrocloride | ANDA | 2024-10-29 |
| methadose | New Drug Application | 2024-07-24 |
| methadose methadose | New Drug Application | 2011-01-28 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| opioid-related disorders | EFO_0005611 | D009293 | F11 |
| intractable pain | — | D010148 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AC: Diphenylpropylamine derivative analgesics
— N02AC52: Methadone, combinations excl. psycholeptics
— N07: Other nervous system drugs in atc
— N07B: Drugs used in addictive disorders
— N07BC: Drugs used in opioid dependence
— N07BC02: Methadone
HCPCS
Code | Description |
|---|---|
| G2067 | Medication assisted treatment, methadone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare-enrolled opioid treatment program) |
| G2078 | Take-home supply of methadone; up to 7 additional day supply (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure |
| H0020 | Alcohol and/or drug services; methadone administration and/or service (provision of the drug by a licensed program) |
| J1230 | Injection, methadone hcl, up to 10 mg |
| S0109 | Methadone, oral, 5 mg |
Clinical
Clinical Trials
515 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 26 | 41 | 26 | 15 | 95 | 195 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 8 | 14 | 6 | 7 | 43 | 76 |
| Postoperative pain | D010149 | — | G89.18 | 2 | 5 | 4 | 19 | 9 | 38 |
| Pain | D010146 | EFO_0003843 | R52 | 9 | 10 | 7 | 4 | 10 | 36 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 7 | 4 | 3 | 7 | 11 | 31 |
| Hepatitis c | D006526 | — | B19.2 | 5 | 3 | 3 | 6 | 14 | 31 |
| Chronic pain | D059350 | HP_0012532 | — | 6 | 6 | 3 | 5 | 13 | 30 |
| Cocaine-related disorders | D019970 | — | F14 | 6 | 14 | 3 | 1 | 8 | 30 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 3 | 1 | 8 | 13 | 26 |
| Heroin dependence | D006556 | EFO_0004240 | — | 1 | 4 | 2 | 4 | 14 | 24 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cancer pain | D000072716 | — | G89.3 | 1 | 2 | 4 | — | 5 | 11 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | 3 | 1 | 3 | — | 4 | 10 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 3 | 4 |
| Opiate substitution treatment | D058850 | — | — | — | — | 2 | — | 2 | 4 |
| Acute pain | D059787 | — | R52 | 1 | — | 2 | — | 1 | 4 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | 3 | 1 | — | — | 3 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | — | — | 1 | — | 2 | 3 |
| Intractable pain | D010148 | — | — | — | — | 1 | — | 1 | 2 |
| Herpes simplex | D006561 | — | B00 | — | — | 1 | — | 1 | 2 |
| Hernia | D006547 | HP_0100790 | K40-K46 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parasomnias | D020447 | — | G47.5 | 1 | 1 | — | — | 2 | 4 |
| Hyperalgesia | D006930 | — | — | 1 | 1 | — | — | 2 | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | 2 | 3 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | 1 | 2 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | 1 | 1 | — | — | 1 | 2 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | 1 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | 1 | 2 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 1 | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | — | — | 1 | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | 1 | 8 |
| Recurrence | D012008 | — | — | 2 | — | — | — | 2 | 4 |
| Sleep wake disorders | D012893 | — | G47 | 1 | — | — | — | 3 | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Bronchiolitis | D001988 | HP_0011950 | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Kyphosis | D007738 | HP_0002808 | M40.20 | 1 | — | — | — | — | 1 |
| Intervertebral disc degeneration | D055959 | HP_0008419 | — | 1 | — | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 10 | 10 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 5 | 5 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 3 | 3 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 3 | 3 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 3 | 3 |
| Retention in care | D000076522 | — | — | — | — | — | — | 3 | 3 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 2 | 2 |
| Drug overdose | D062787 | — | — | — | — | — | — | 2 | 2 |
| Leukemia | D007938 | — | C95 | — | — | — | — | 2 | 2 |
| Risk-taking | D012309 | — | — | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methadone |
| INN | methadone |
| Description | Methadone is a racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction. It has a role as an opioid analgesic, a mu-opioid receptor agonist, a xenobiotic, an environmental contaminant, a NMDA receptor antagonist and a serotonin uptake inhibitor. It contains a levomethadone and a dextromethadone. |
| Classification | Small molecule |
| Drug class | Opioid |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 76-99-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL651 |
| ChEBI ID | 6807 |
| PubChem CID | 4095 |
| DrugBank | DB00333 |
| UNII ID | UC6VBE7V1Z (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Methadone
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Trends
PubMed Central
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Additional graphs summarizing 38,202 documents
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Safety
Black-box Warning
Black-box warning for: Diskets, Methadone, Methadone hydrochloride, Methadone hydrochloride methadose, Methadone hydrochloride methadose dispersible, Methadone hydrocloride, Methadose, Methadose methadose, Methadose methadose sugar-free
Adverse Events
Top Adverse Reactions
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35,833 adverse events reported
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