1230 Stevens-Johnsons Syndrome After Armodafinil Use

Abstract

Introduction:

Stevens- Johnson Syndrome (SJS) is reported as a possible adverse effect for modafinil and armodafinil, yet no definitive case has been presented in the literature. A warning associating these drugs with SJS is primarily based on a rash that formed on one patient during modafinil clinical trials. We present a case of a patient who developed SJS less than two weeks after starting armodafinil.

Report of Case:

A 21 year old female with a significant history of maintenance immunotherapy for common allergies presented with excessive daytime sleepiness dating back since childhood despite 9 hr sleep per night. Diagnostic testing with PSG demonstrated no significant obstructive breathing, but the MSLT showed markedly shortened sleep onset latencies (mean=1.6 min.) without REM. Final diagnosis was idiopathic hypersomnia. She was started on Nuvigil 150 mg PO QAM. The medication was discontinued 13 days later after experiencing mild subjective fevers and cervical lymphadenopathy on day 9. Within 12 hours of discontinuation, ulcers appeared on her mouth and lips, with a generalized rash that spread over her body. She was hospitalized on day 14, received supportive care, and was diagnosed with biopsy supported SJS. Follow up 3 months later showed subtle skin discolorations over blistered areas. She remained symptomatic with daytime sleepiness. No alternative agent was initiated.

Conclusion:

On label warnings for both modafinil and armodafinil report the risk for serious rash, including SJS. Of the 13 cases of non-specific rash resulting in discontinuation of modafinil in clinical trials, only 1 case was reported as possible SJS, all occurring in pediatric patients less than 17 years old. There are no known predictive risk factors for skin rash prior to starting treatment, nor are there predictive features of rash severity once it appears. Recommended course of action is to promptly discontinue modafinil or armodafinil at symptom onset.