Informing Treatment Decisions in the Central Disorders of Hypersomnolence: A Pragmatic Clinical Trial of Modafinil Versus Amphetamines

2018 Strategic Research Grant

Lynn Marie Trotti, MD, MSc
Emory University School of Medicine

Key Project Outcomes

This was a randomized, controlled, blinded, non-inferiority trial comparing modafinil and amphetamine-dextroamphetamine for the treatment of idiopathic hypersomnia (n = 33) and narcolepsy type 2 (n = 11).  Participants titrated on a fixed schedule to their optimal dose (balancing benefit and side effects), starting with modafinil 100 mg once a day or amphetamine-dextroamphetamine 10 mg once a day to as high as modafinil 200 mg twice a day or amphetamine-dextroamphetamine 20 mg twice a day.  Epworth sleepiness scores were improved a similar amount by both treatments, but non-inferiority of amphetamine-dextroamphetamine on Epworth was not demonstrated.  Dropouts due to adverse events were more common in the modafinil (n = 7) than amphetamine-dextroamphetamine (n = 2) group.