Clinical Trials

Modafinil (Provigil®) is the only Food and Drug Administration (FDA)-approved medication for improving daytime functioning and alertness in those who have only partially responded to CPAP. Three randomized, double-blind, placebo-controlled trials examined the efficacy of oral modafinil 200 mg to 400 mg once daily in patients with excessive daytime sleepiness associated with OSA. Two of the OSA trials were of parallel-group design (n = 157 and 309; treatment duration 4 and 12 weeks) and the third was a crossover trial (n = 30; treatment duration 2 weeks). In both parallel trials, but not in the crossover trial, modafinil (dosage of 200 mg or 400 mg) improved wakefulness as measured on the Epworth sleepiness scale, and significantly more patients were "better" with no reduction in CPAP use. Modafinil (Table 1, for more information on modafinil see also Chapter 13) improved functional status and health-related quality of life to a significantly greater extent than placebo (8-10). In the smaller, crossover trial, there was no significant between-group

TABLE 1 Medications That May Improve Obstructive Sleep Apnea

Medication

Mechanism for clinical benefit

Special considerations

Modafinil (treatment)

Decreases daytime sedation 200 mg in morning

Stimulates hypocretin/orexin system Nausea, headache common

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Sleep Apnea

Sleep Apnea

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