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A Double-blind, Placebo-Controlled, Crossover Study of Sildenafil in Obstructive Sleep Apnea
Suely Roizenblatt, MD, PhD;
Christian Guilleminault, MD, BiolD;
Dalva Poyares, MD, PhD;
Fátima Cintra, MD, PhD;
Adriana Kauati, PhD;
Sergio Tufik, MD, PhD
Arch Intern Med. 2006;166:1763-1767.
Background Sildenafil prolongs the action of cyclic guanosine monophosphate and nitric oxide by inhibiting cyclic guanosine monophosphate–specific phosphodiesterase 5. It is largely used for erectile dysfunction, a highly prevalent condition in obstructive sleep apnea. Because nitric oxide promotes upper airway congestion, muscle relaxation, and pulmonary vasodilation, the aim of this study was to establish the impact of a single 50-mg dose of sildenafil on the sleep of patients with severe obstructive sleep apnea.
Methods Fourteen middle-aged men with severe obstructive sleep apnea were consecutively selected for this double-blind, placebo-controlled, crossover study. Exclusion criteria were obesity, cardiovascular and/or respiratory disease, and conditions that interfere with sleep. All-night polysomnography was preceded by a single 50-mg dose of sildenafil or matching placebo randomly administered at bedtime, after a washout period of 1 week.
Results In comparison to placebo, a single 50-mg dose of sildenafil significantly increased the percentage of total sleep time with an arterial oxygen saturation of less than 90% (mean ± SD, 14.2% ± 9.1% vs 8.5% ± 3.2%, P<.01), without a difference in the nadir of oxygen desaturation. The mean arterial oxygen saturation also decreased (92.1% ± 1.91% vs 93.8% ± 1.3%, P = .02), and the desaturation index increased (30.3 ± 18.1 events per hour vs 18.5 ± 14.6 events per hour, P<.001). There was an increase in apnea-hypopnea index (42.4 ± 25.5 events per hour vs 34.6 ± 24.1 events per hour, P = .01), involving mostly obstructive events.
Conclusion In patients with severe obstructive sleep apnea, a single 50-mg dose of sildenafil at bedtime worsens respiratory and desaturation events.
Author Affiliations: Department of Psychobiology, Federal University of São Paulo, São Paulo, Brazil (Drs Roizenblatt, Poyares, Cintra, Kauati, and Tufik); and Sleep Disorders Center, Stanford University Medical Center, Stanford, Calif (Dr Guilleminault).
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Sleep and health: everywhere and in both directions.
Zee and Turek
Arch Intern Med 2006;166:1686-1688.
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