Table 2.

A comparison of FDA‐approved pharmacological medications for FM (pivotal studies) 32, 49, 50, 51

Drug	FDA approval	Mechanism of action	Efficacy studies	Primary end‐points	Dosing	Adverse eventsa
Pregabalin	21 June 2007	Non‐selective α2δ ligand	14 weeks, randomised, double‐blind, placebo‐controlled 6 months, randomised, withdrawal	Pain reduction, improvements in PGIC and FIQ	300–450 mg/day; start at 75 mg bid (might increase to 150 mg bid within 1 week); max dose 225 mg bid	Dizziness, somnolence, dry mouth, oedema, blurred vision, weight gain, abnormal thinking
Duloxetine	16 June 2008	SNRI	3 months, randomised, double‐blind, placebo‐controlled 6 months, randomised, double‐blind, placebo‐controlled	Pain reduction, improvements in PGIC and FIQ	60 mg/day; start 30 mg/day for 1 week then increase to 60 mg/day	Nausea, dry mouth, somnolence, constipation, decreased appetite, hyperhidrosis
Milnacipran	14 January 2009	SNRI	3 months, randomised, double‐blind, placebo‐controlled 6 months, randomised, double‐blind, placebo‐controlled	Composite end‐point that concurrently evaluated improvement in pain (VAS), physical function (SF‐36 PCS) and patient global assessment (PGIC)	100 mg/day; start 12.5 mg/day, increasing incrementally to 50 mg bid in 1 week; maximum dose 100 mg bid	Nausea, constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, hypertension

bid, twice daily; FDA, US Food and Drug Administration; FIQ, Fibromyalgia Impact Questionnaire; FM, fibromyalgia; PGIC, patient global impression of change; SF‐36 PCS, Short‐Form 36 Physical Component Summary; SNRI, serotonin‐norepinephrine re‐uptake inhibitor; VAS, visual analogue scale.

^aThe most commonly reported adverse events are shown. For full details, please refer to the prescribing information for each drug.