Methylphenobarbital (

INN Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...

), also known as mephobarbital (

USAN 280px, "Samguk Sagi" Book 04. Silla's Records. In 512, Usan-guk（于山國）was Ulleungdo（鬱陵島） Usan-guk, or the State of Usan, occupied Ulleung-do and the adjacent islands during the Korean Three Kingdoms period. According to th ...

JAN Jan, JaN or JAN may refer to: Acronyms * Jackson, Mississippi (Amtrak station), US, Amtrak station code JAN * Jackson-Evers International Airport, Mississippi, US, IATA code * Jabhat al-Nusra (JaN), a Syrian militant group * Japanese Article Num ...

) and mephobarbitone ( BAN), marketed under

brand name A brand is a name, term, design, symbol or any other feature that distinguishes one seller's good or service from those of other sellers. Brands are used in business, marketing, and advertising for recognition and, importantly, to create an ...

s such as Mebaral, Mephyltaletten, Phemiton, and Prominal, is a

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...

which is a

barbiturate Barbiturates are a class of depressant drugs that are chemically derived from barbituric acid. They are effective when used medically as anxiolytics, hypnotics, and anticonvulsants, but have physical and psychological addiction potential as we ...

derivative and is used primarily as an

anticonvulsant Anticonvulsants (also known as antiepileptic drugs or recently as antiseizure drugs) are a diverse group of pharmacological agents used in the treatment of epileptic seizures. Anticonvulsants are also increasingly being used in the treatment of b ...

, but also as a

sedative A sedative or tranquilliser is a substance that induces sedation by reducing irritability or excitement. They are CNS depressants and interact with brain activity causing its deceleration. Various kinds of sedatives can be distinguished, but t ...

and

anxiolytic An anxiolytic (; also antipanic or antianxiety agent) is a medication or other intervention that reduces anxiety. This effect is in contrast to anxiogenic agents which increase anxiety. Anxiolytic medications are used for the treatment of anxi ...

. It is the ''N''-methylated analogue of

phenobarbital Phenobarbital, also known as phenobarbitone or phenobarb, sold under the brand name Luminal among others, is a medication of the barbiturate type. It is recommended by the World Health Organization (WHO) for the treatment of certain types of ep ...

and has similar indications, therapeutic value, and tolerability.

Approval history

* 1935 – Mebaral was introduced by Winthrop Pharmaceuticals. * 2001 – Methylphenobarbital discontinued in the UK. * 2003 – Mebaral was acquired by Ovation Pharmaceuticals (a specialty pharmaceutical company that acquired under-promoted branded pharmaceutical products). * 2009 – Ovation was acquired by

Lundbeck H. Lundbeck A/S (commonly known simply as Lundbeck) is a Danish international pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of pharmaceuticals across the world. The company’s products are target ...

, which now markets Mebaral. * 2012 – Lundbeck announced that they were abandoning the product in the US as of January 6, 2012. The stated reason was because "the company thoroughly evaluated all avenues for keeping Mebaral available to patients, but ultimately concluded that no matter what steps they .e. Lundbecktook, patients would be forced to transition to a new therapy." The company further stated in a letter on its website Letter from Lundbeck to prescribers
/ref> that under the FDA's

Unapproved Drugs Initiative Unapproved Drugs Initiative is a program by the U.S Food and Drug Administration announced in June 2006 to remove unapproved drugs from the market. some 14 categories of drugs have been affected. It has been controversial due to the resulting inc ...

, FDA is no longer willing to allow the drug to be grandfathered. A new drug application would have needed to have been submitted to gain marketing approval, which would have taken an estimated five years, during which time patients would be required to change their therapies in any case. The last available tablets bore an

expiration date An expiration date or expiry date is a previously determined date after which something should no longer be used, either by operation of law or by exceeding the anticipated shelf life for perishable goods. Expiration dates are applied to selecte ...

of March 31, 2012, and the drug will no longer be available in the US when supplies are depleted.

Overdose

Symptoms of overdose of mephobarbital include confusion, decrease in or loss of reflexes,

somnolence Somnolence (alternatively sleepiness or drowsiness) is a state of strong desire for sleep, or sleeping for unusually long periods (compare hypersomnia). It has distinct meanings and causes. It can refer to the usual state preceding falling asleep ...

fever Fever, also referred to as pyrexia, is defined as having a body temperature, temperature above the human body temperature, normal range due to an increase in the body's temperature Human body temperature#Fever, set point. There is not a single ...

, irritability, hypothermia, poor judgment, shortness of breath or slow/troubled breathing, slow heartbeat, slurred speech, staggering, trouble in sleeping, unusual movements of the eyes, weakness.

References

{{GABAAergics Anticonvulsants Barbiturates GABAA receptor positive allosteric modulators

Approval history

Overdose

See also

References