What is the highest dose of sildenafil (Viagra) used in clinical trials for patients with erectile dysfunction?

Highest Dose of Sildenafil Used in Clinical Trials

The highest dose of sildenafil used in clinical trials for erectile dysfunction was 200 mg, though the maximum recommended dose is 100 mg taken once daily as needed. 1

Clinical Trial Dosing Range

• Clinical trials evaluated sildenafil at doses ranging from 5 mg to 200 mg in over 3,000 patients with erectile dysfunction of various etiologies. 1
• The standard dosing regimen tested in trials began at 50 mg, with adjustments to 25 mg or 100 mg based on tolerability and efficacy. 1

Dose-Response Relationship and Maximum Recommended Dose

• Improvement in erectile function is dose-related when comparing 25 mg to 50 mg, but there is less additional benefit when increasing from 50 mg to 100 mg. 2, 3
• The 100 mg dose represents the maximum recommended dose for erectile dysfunction, taken no more than once daily. 1
• In titrated-dose trials, the most commonly effective doses were 50 mg or 100 mg, though lower doses (25 mg) were effective in some patients. 1

Important Caveat About Higher Doses

• Higher doses of sildenafil are associated with a greater risk for adverse effects, necessitating dose titration to balance efficacy and tolerability. 2
• While doses up to 200 mg were studied in clinical trials, treatment with doses higher than the standard maximum of 100 mg is not recommended for erectile dysfunction. 1

Common Pitfall to Avoid

• Before declaring treatment failure at maximum dose, ensure the patient has completed at least 5 separate attempts, as many apparent failures are due to inadequate trials, improper timing, lack of sexual stimulation, or modifiable factors such as heavy alcohol use. 2, 3