Carisoprodol (SOMA) has been sold in the U.S. since April 1959. The drug is approved by the Food and Drug Administration (FDA) for the relief of discomfort associated with acute, painful muscle conditions. Carisoprodol does not directly relax tense skeletal muscles in humans; the drug’s effect may be related to its...
Do Not Use: Do not use these drugs because they are no more effective than aspirin and related drugs, are sedating and break down into a chemical with a potential for abuse.
Carisoprodol (SOMA) has been sold in the U.S. since April 1959. The drug is approved by the Food and Drug Administration (FDA) for the relief of discomfort associated with acute, painful muscle conditions. Carisoprodol does not directly relax tense skeletal muscles in humans; the drug’s effect may be related to its sedative properties.
The body breaks down carisoprodol to meprobamate, an old tranquilizer, which is also listed as a Do Not Use drug. Meprobamate is a controlled substance, and as of December 2011, carisoprodol has also been placed on the Drug Enforcement Administration's (DEA's) controlled-substance list.  In addition, carisoprodol, like meprobamate, has been shown to have a potential for abuse and dependence. Discontinuation of carisoprodol can produce withdrawal signs.,
Carisoprodol has not been shown to be any more effective than painkillers or anti-inflammatory drugs such as aspirin for relieving the pain of local muscle spasm.
Carisoprodol should be used only for short-term treatment. In post-marketing cases, prolonged use has been associated with dependence, withdrawal and abuse.
Carisoprodol occasionally causes a reaction within the first few minutes or hours after the first dose. Symptoms of a reaction are agitation, confusion, unsteadiness, disorientation, weakness, speech or vision problems, and temporary inability to move arms or legs.
Some people taking carisoprodol have experienced drowsiness, lightheadedness, dizziness, nausea, vomiting, heartburn, abdominal distress, constipation, diarrhea and loss of appetite as side effects.
Driving accidents associated with the use of carisoprodol have been reported in post-marketing cases.
Regulatory actions surrounding carisoprodol
2007: In November, the European Medicines Agency (EMA) announced that it had recommended the suspension of the marketing of all medicinal products containing carisoprodol because the agency concluded that the risks of using these products are greater than their benefits. Among the reasons stated by the EMA was “evidence of increased risk of abuse, addiction, intoxication and psychomotor impairment [such as an inability to drive a car safely] associated with the use of carisoprodol. The EMA has advised patients who are receiving carisoprodol to consult their doctor before stopping the drug due to the risk of withdrawal symptoms.”
No such plans to ban these drugs have been announced by the FDA.
2009: The FDA updated the product label of carisoprodol-containing products to include information that there have been reports of motor vehicle accidents associated with the use of these products.
2011: In December, the administrator of the DEA announced that a decision was made to place carisoprodol into Schedule IV of the Controlled Substances Act.