LONG-TERM USE OF MODAFINIL AND ARMODAFINIL IN PEDIATRIC PATIENTS WITH NARCOLEPSY.
While modafinil and armodafinil are recommended as first line treatments for excessive daytime sleepiness (EDS) associated with narcolepsy in adults, these medications have not been approved by the FDA for pediatric use. Published studies on the use of modafinil/armodafinil in children and adolescents with narcolepsy are limited. We aimed to investigate long term effectiveness and tolerability of modafinil and armodafinil in pediatric patients with narcolepsy treated at a specialized sleep disorders clinic.
A retrospective chart review of the past 10 years identified 74 patients (14.2 ± 3.2 y, 36 males) that met ICSD-3 diagnostic criteria for narcolepsy. Demographical, clinical, electophysiological characteristics, and medication history were included into data analysis.
Modafinil was initially prescribed to 32 patients at a starting dose range of 50-100mg once daily. The majority of patients - 90 % remained on modafinil with a gradual dose increase to a maximum of 400-600mg /day over the course of clinical follow-ups. Average maintenance dose of modafinil was 340mg±162. 31 patients were initiated on armodafinil at a starting dose range of 50-75mg/ day. The maximum dose used was 250-400mg/day with an average maintenance dose of 225mg±66.9. 25 patients sustained clinical response to armodafinil without reported side effects, 6 were switched to modafinil. Almost half of the patients received concomitant treatment for psychiatric disorder(s) which included medications, such as sertraline, citalopram, escitalopram, fluoxetine, venlafaxine, bupropion, aripiprazole, quetiapine, lamotrogine, and lithium carbonate. Six patients required addition of a psychostimulant, methylphenidate or amphetamine/ dextroamphethamine, to achieve optimal control of EDS. Reported side effects included: loss of appetite (n=1), headache and nausea (n=1), anxiety/agitation (n=1).
This chart review demonstrated that modafinil and armodafinil were effective and well tolerated by pediatric patients with narcolepsy over a long period of clinical follow ups (up to 10 years). Concomitant administration of other psychopharmacological agents did not result in any significant side effects. Use of modafinil and armodafinil significantly improved patient’s ability to stay awake and did not exacerbate preexisting psychiatric conditions. Prospective, controlled studies of modafinil and armodafinil for the treatment of EDS associated with early-onset narcolepsy are needed.