Pemoline, formerly sold under the brand name Cylert among others, is a stimulant medication which has been used in the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
[2] Side effects of pemoline include insomnia, decreased appetite, abdominal pain, irritability, and headaches.
[6][7] Pemoline is a stimulant and acts as a selective dopamine reuptake inhibitor and releasing agent.
[5] Pemoline is a schedule IV controlled substance in the United States due to its relation to other stimulants and a potential for misuse.
[17] Side effects of pemoline include insomnia, decreased appetite, abdominal pain, irritability, and headaches.
However the reactions proved idiosyncratic and unpredictable, with patients sometimes taking the drug with no issue for months or even years, before suddenly developing severe liver toxicity.
[14] On the other hand, there are no cases of liver failure associated with pemoline in Japan, although it is used at lower doses and is only prescribed for the niche indication of narcolepsy in this country.
[citation needed] The pharmacodynamics of pemoline are poorly understood and its precise mechanism of action hasn't been definitively determined.
[1][2] However, pemoline has similar activity and effects to those of other psychostimulants, and in animals the medication appears to act as a dopamine reuptake inhibitor and releasing agent.
[10] In contrast to most other stimulants, pemoline appears to produce no significant central or peripheral noradrenergic effects.
[1][5] Cases of serious liver toxicity and associated death related to pemoline in children and adolescents were reported to the United States Food and Drug Administration's MedWatch between 1977 and 1996.
[7] Warnings for liver toxicity for pemoline were added to the United States Food and Drug Administration (FDA) label for the medication in December 1996 and a black box warning was added in June 1999 along with requirements for written consent and frequent monitoring of liver enzymes.
[24][17] Pemoline was formerly marketed under the brand names Cylert, Betanamin, Ceractiv, Hyperilex, Kethamed, Ronyl, Stimul, Tamilan, Tradon, Tropocer, and Volital.
[5] However, the medication is said to be rarely used in Japan as narcolepsy is a niche indication and as clinicians are wary of the liver toxicity that it has been associated with.
[15] Pemoline is Schedule IV Non-Narcotic (Stimulant) controlled substance with a DEA ACSCN of 1530 and is not subject to annual manufacturing quotas.
[16] Pemoline has been studied in and reported to be effective in the treatment of fatigue due to multiple sclerosis and HIV-related disease.