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Effectiveness of Pitolisant in the Treatment of Narcolepsy

Summary and Comment |
October 30, 2013

Effectiveness of Pitolisant in the Treatment of Narcolepsy

  1. Jaime Toro, MD

Pitolisant shows promise as an alternative to modafinil, pending further research.

  1. Jaime Toro, MD

Narcolepsy is a clinical syndrome of daytime sleepiness along with cataplexy, hypnagogic hallucinations, and sleep paralysis. Narcolepsy results from the loss of the neuropeptides orexin-A and orexin-B. Several nonpharmacologic therapies may benefit patients with narcolepsy, such as avoiding certain drugs, napping, sleep hygiene, and psychosocial support. Modafinil is a first-line pharmacologic therapy because it provides good control of sleepiness and in general is well tolerated. However, some evidence in animal models has suggested that pitolisant has no potential drug abuse liability, whereas the evidence on abuse potential is not clear for modifinil.

For this double-blind randomized, parallel-group, controlled trial, researchers recruited patients with narcolepsy from 32 sleep disorder centers in five European countries. Of 110 patients screened, 95 were eligible and randomly assigned to treatment: 30 to placebo, 32 to pitolisant (10, 20, or 40 mg daily), and 33 to modafinil (100, 200, or 400 mg daily); intention-to-treat data included 74 patients. Over an 8-week treatment period, Epworth Sleepiness Scale scores were reduced by 3.4 points in the placebo group, by 5.8 in the pitolisant group, and by 6.9 in the modafinil group. There was a superiority criterion of pitolisant over placebo and a noninferiority of pitolisant versus modafinil. Three of the modafinil recipients had withdrawal symptoms upon stopping the drug, versus none of the pitolisant recipients.

Comment

This study shows that pitolisant is efficacious in treating excessive daytime sleepiness. Future studies of cost-effectiveness of pitolisant compared with modafinil would be of great interest. If the results of this study are supported by further research, this drug could offer a promising treatment for narcolepsy.

  • Disclosures for Jaime Toro, MD at time of publication Editorial boards Multiple Sclerosis and Related Disorders

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