Identification of a drug product called Mandrax./nIs it available on licence in Sweden?/nA 50-years

Fråga: Identification of a drug product called Mandrax.

Is it available on licence in Sweden?

A 50-years-old woman with drug and alcohol abuse claims that her alcohol abuse was much less when she used Mandrax (about 30 years ago). The physician wants to know more about the drug.

Sammanfattning: Mandrax is a trade name for methaqualone, a hypnotic with pharmacological similarities to barbiturates.

It was withdrawn in 1979 because of abuse problems. It is not available on licence in Sweden.

Svar: Methaqualone (Mandrax) is a quinazolone derivate with hypnotic and sedative effects similar to those of barbiturates but was originally synthesized as part of an Indian program looking for antimalarial drugs (1).

In addition to hypnotic-sedative effects, methaqualone possesses anticonvulsant, antispasmodic, local anesthetic and weak anti-histaminic properties.

Methaqualone has been withdrawn in many countries (1979 in Sweden) due to severe abuse problems. It may produce inebriation in addition to sedation in some subjects. Many abusers liken the effects of methaqualone to those of heroin.

Like short-acting barbiturates, methaqualone is particularly dangerous when consumed together with alcohol as the two substances act synergistically. Methaqualone has been called "dry alcohol" among drug abusers. Most methaqualone-related deaths are the result of drug overdose mixed with alcohol (1,2,3).

During sedation with methaqualone, fatigue and occasionally dizziness and torpor may occur. With hypnotic doses, there may be transient paresthesias preceding the onset of sleep. Persisting paresthesias and other signs of peripheral neuropathy that last for months to years may also occur. Restlessness and anxiety have been observed instead of sedation and sleep. Hangover, headache, dyspepsia, drowsiness and urticaria are other side effects that have been reported (2).

Methaqualone has a kinetic profile which can be described by a two-compartment model. This gives a terminal half-life of about 20-40 hours in the elimination phase (4). After regular intake steady state conditions will be established (5).

Withdrawal from the drug can get hazardous if detoxification is not properly supervised. Initial withdrawal signs are headache and severe cramps, followed by convulsions and possibly stomach hemorrhaging three to five days after discontinuing the drug. Addiction symtoms are irritability, sleeplessness, delirium tremens, mania and convulsions (3).

Mandrax is not available in Sweden on licence. 1 Alvan G, Holmstedt B, Lindgren JE: Metakvalon - historien om ett sömnmedel. Läkartidningen 1974; 71: 3777-3780 2 Goodman & Gilman, The pharmacological basis of therapeutics. 1990; 8th ed: 365-366 3 Ostrenga JA: Methaqualone - A Dr Jekyll and Mr Hyde? Clin Toxicol 1974; 6: 607-609 4 Alvan G, Lindgren JE, Bogentoft C, Ericsson Ö: Plasma kinetics of methaqualone in man after single oral doses. Eur J Clin Pharmacol 1973; 6: 187-190 5 Alvan G, Ericsson Ö, Levander S, Lindgren JE: Plasma concentrations and effects of methaqualone after single and multiple oral doses in man. Eur J Clin Pharmacol 1974; 7: 449-454