Pemoline
2-amino-5-phenyl-1,3-oxazol-4-one
Overview
Pemoline belongs to Stimulants.
Effects
- A gradual, relatively mild stimulant effect, improved wakefulness, attention and concentration, that builds over days to weeks rather than acutely, with less of the sharp 'rush' of amphetamine.
- Common stimulant side effects: insomnia, reduced appetite and weight loss, raised heart rate and blood pressure, irritability and headache.
- At high or misused doses: agitation, abnormal involuntary movements (choreoathetosis), and rarely hallucinations or psychosis. The serious, dose-independent risk is liver injury.
Dosing & duration
Oral only, once daily: clinician-prescribed. Figures below are historical clinical ranges, NOT a recreational guide. Pemoline has been withdrawn in most countries because of fatal liver toxicity.. Pemoline was taken once a day by mouth. Its therapeutic effect builds gradually and may not appear until the third or fourth week. There is no safe recreational use: its defining risk is unpredictable, sometimes fatal liver failure that is independent of dose and not reliably prevented by monitoring, which is why it has been withdrawn from most markets.
Dose ranges
≈18.75–112.5 mg once daily (usual effective ≈56–75 mg)
Gradual: often not until week 3–4
Duration
Peak blood levels ≈2–4 h, clinical benefit builds over weeks
Once-daily dosing (half-life ≈7–12 h in adults)
Insomnia/appetite suppression may persist. Liver injury can appear at any time
Chemical & Physical Properties
| Formula | C9H8N2O2 |
| Molar mass | 176.17 g/mol |
| State | Solid |
| Melting point | 256 dec °C |
| Boiling point | Not reported |
| Density | Not reported |
| Vapor pressure | Not reported |
| pKa | 10.5 |
| LogP | 0.7 |
| Solubility | Practically insol in ether, acetone, dil hydrochloric acid. Sol in propylene glycol (1%) and hot alcohol |
| Refractive index | Not reported |
Identifiers & Synonyms
| CAS | 2152-34-3 |
| CAS (enantiomer) | |
| PubChem CID | 4723 |
| InChIKey | NRNCYVBFPDDJNE-UHFFFAOYSA-N |
| InChI | InChI=1S/C9H8N2O2/c10-9-11-8(12)7(13-9)6-4-2-1-3-5-6/h1-5,7H,(H2,10,11,12) |
| SMILES | C1=CC=C(C=C1)C2C(=O)N=C(O2)N |
Synonyms
- Cylert
Pharmacodynamics & Biochemistry
Pemoline (Cylert) is a central nervous system stimulant of the 4-oxazolidinone class: structurally unrelated to the amphetamines or methylphenidate. It appears to act mainly by enhancing dopaminergic neurotransmission: it is described as a dopamine reuptake inhibitor and releasing agent (an indirect dopamine agonist), raising dopamine signalling in the brain. Unusually for a stimulant it produces little peripheral or central noradrenergic effect, which historically gave it a reputation for being less overtly sympathomimetic than amphetamine. Its precise mechanism is poorly characterised, and no reliable quantitative binding constants (Kᵢ/IC50 at the dopamine, noradrenaline or serotonin transporters) have been established for it, so the binding-affinity table is left empty rather than filled with unverified numbers. Its onset is notably slow: the therapeutic effect in ADHD builds gradually and may not be apparent until the third or fourth week of treatment, consistent with an action that is not simply acute transporter blockade. Pemoline is well absorbed orally, reaching peak blood levels at ≈2–4 h, with a half-life of about 7–12 hours in adults (shorter in children), allowing once-daily dosing. It is metabolised in the liver (to a conjugate, pemoline dione and mandelic acid), with roughly half the dose excreted unchanged in the urine.
Biological targets
- DAT
Binding & functional measurements
Pharmacokinetics
| Bioavailability | Oral, well absorbed |
| Tmax | ≈2–4 h |
| Half-life | ≈7–12 h (adults, shorter in children) |
| Vd | Not reported |
| Protein binding | Low (~≤50%, reports vary) |
| Metabolism | Hepatic (conjugate, pemoline dione, mandelic acid) |
| Excretion | Renal. ~50% excreted unchanged |
Toxicology & Safety
Not reported
Pemoline's defining hazard is idiosyncratic, sometimes fatal liver toxicity. Post-marketing surveillance linked it to acute hepatic failure: at least 21 reported cases of liver failure, of which about 13 ended in death or liver transplantation: occurring unpredictably and not reliably caught by routine liver-function monitoring. This risk led to its withdrawal from the market in the UK (1997) and Canada (1999) and to the withdrawal of Cylert and its generics in the United States (2005). It remains available in only a few countries (e.g. Japan, for narcolepsy). As a stimulant it can also cause insomnia, appetite loss, weight loss, tachycardia, raised blood pressure and irritability, and, at high or misused doses, agitation, abnormal involuntary movements (choreoathetosis) and, rarely, psychosis. It carries some potential for dependence and misuse. Because the liver injury is idiosyncratic and can be rapid, it is generally regarded as a last-line agent where it is used at all.[2][3]
Legal Status
US: Schedule IV. UK: Class C. DE: BtMG Anlage III
Interactions & Contraindications
Drug interactions
Contraindications
No interactions or contraindications listed.
Usage & Context
- A once-daily prescription stimulant formerly used for attention-deficit hyperactivity disorder (ADHD) and for narcolepsy / excessive daytime sleepiness, marketed chiefly as Cylert (also Volital, Betanamin and others).
- Now largely of historical interest: withdrawn from the UK, Canadian and US markets because of fatal hepatotoxicity, and available in only a few countries (notably Japan, for narcolepsy).
- Occasionally encountered as a stimulant of misuse, but far less so than amphetamine or methylphenidate.
Sources & Evidence
- PubChem: Pemoline (CID 4723) — identifiers & experimental properties
- Safer DJ, Zito JM, Gardner JE (2001). Pemoline hepatotoxicity and postmarketing surveillance. J Am Acad Child Adolesc Psychiatry 40:622-9.
PMID 11392339 · doi:10.1097/00004583-200106000-00006
- Wikipedia: Pemoline — pharmacology, hepatotoxicity, market-withdrawal history, pharmacokinetics & legal status CC BY-SA 4.0
- DEA Diversion Control Division: Controlled Substance Schedules (pemoline is Schedule IV, code 1530)
- GOV.UK: Controlled drugs list — pemoline is a Class C controlled drug (Misuse of Drugs legislation) OGL v3.0
- BtMG Anlage III — Pemolin (mit Ausnahme für Zubereitungen bis 20 mg je abgeteilter Form), gesetze-im-internet.de