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Modafinil and pramipexole‐associated somnolence

We read with interest the paper by Hauser et al. 1 on one case of modafinil use in a parkinsonian patient suffering from pramipexole-associated somnolence. The authors conclude that “modafinil may be a useful treatment for dopamine agonist and levodopa-induced somnolence and sudden episodes of sleepiness.” As with any single case report, this interesting observation deserves, from a pharmacological point of view, some comments. First, prospective randomized double-blind studies remain to be conducted to verify the efficacy suggested by this preliminary observation. Second, the safety of modafinil in parkinsonian patients should be investigated. It is known that the safety profile of a drug can differ according to the underlying disease. What about the risk of pharmacodependence (drug addiction) which was largely discussed with modafinil? In fact, because of such a concern, modafinil is only marketed in France for narcolepsy or idiopathic hypersomnia under strict electrophysiological survey and can only be prescribed by neurologists and/or sleep specialists. The long-term effects of such a drug on extrapyramidal symptoms remain also unknown, although some antiparkinsonian and possibly neuroprotective effects were described in the MPTP-treated common marmoset. 4 Moreover, some cases of bucco-facial dyskinesias have been reported with modafinil. 5 Third, in the absence of comparative drugs or dechallenge/rechallenge design, a spontaneous improvement, although unlikely, cannot be excluded to allow definite imputability (causality) analysis. Fourth, and maybe more important, addition of a drug (with its own potential adverse reactions) to suppress (or decrease) adverse reactions related to another drug is not in accordance with pharmacological logic and best therapeutic practice and guidelines. It might be preferable, safer, and less expensive to try first to replace the offending drug by an alternative antiparkinsonian therapy, although little is known about the respective risk of somnolence among various antiparkinsonian medications.