Medical uses

Tramadol (a schedule IV drug in the US) is used primarily to treat mild to severe pain, both acute and chronic.^[17][18] There is moderate evidence for use as a second-line treatment for fibromyalgia but is not FDA approved for this use,^[19] however, its use is approved for treatment of fibromyalgia as a secondary painkiller by the NHS.^[20]

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Its analgesic effects take about one hour to come into effect and 2 to 4 h to peak after oral administration with an immediate-release formulation.^[18][17] On a dose-by-dose basis, tramadol has about one-tenth the potency of morphine (thus 100 mg is commensurate with 10 mg morphine but may vary) and is practically equally potent when compared with pethidine and codeine .^[21] For pain moderate in severity, its effectiveness is equivalent to that of codeine at low doses, and hydrocodone at very high doses; for severe pain it is less effective than morphine.^[17]

These painkilling effects last about 6 h.^[18] The potency of analgesia varies considerably as it depends on an individual’s genetics. People with specific variants of CYP2D6 enzymes may not produce adequate amounts of the active metabolite (desmetramadol) for effective pain control.^[9][17]

Sleep medicine physicians sometimes prescribe tramadol (or other opiate medications) for refractory restless legs syndrome (RLS);^[22][23] that is, RLS that does not respond adequately to treatment with first-line medications such as dopamine agonists (like pramipexole) or alpha-2-delta (α₂δ) ligands (gabapentinoids), often due to augmentation.^[24]

Contraindications

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Tramadol may not provide adequate pain control for individuals with certain genetic variants of CYP2D6 enzymes as they metabolize tramadol to the inactive molecule.^[17][9] These genetic polymorphisms are not currently routinely tested for in clinical practice.

Pregnancy and lactation

Tramadol’s use in pregnancy is generally avoided, as it may cause some reversible withdrawal effects in the newborn. A small prospective study in France found, while an increased risk of miscarriages existed, no major malformations were reported in the newborn.^[26] Its use during lactation is also generally advised against, but a small trial found that infants breastfed by mothers taking tramadol were exposed to about 2.88% of the dose the mothers were taking. No evidence of this dose having a harmful effect on the newborn was seen.^[26]

Labor and delivery

Its use as an analgesic during labor is not advised due to its long onset of action (1 hour).^[26] The ratio of the mean concentration of the drug in the fetus compared to that of the mother when it is given intramuscularly for labor pains has been estimated to be 1:94