Treatments for hypersomnia: new data on pitolinum

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Written by Stephanie LG. and published on 14/02/2021

Hypersomnia is a sleep disorder that can be disabling for daily life. Currently, few treatments for hypersomnia are available and they do not work in all patients. The pitolator could be an interesting drug alternative for patients who are resistant or intolerant to the usual treatments.

Pitolan in the treatment of hypersomnia

When it was first marketed in 2016, the pitolator was considered to be "the most effective way to reduce the risk of infection". a minor therapeutic advance "by the HAS (Haute Autorité de Santé) in treatment of hypersomnia. At that time, too little data was available. Nevertheless, in view of the " significant therapeutic need for new treatments in this disease "The molecule has been granted a Marketing Authorisation (MA).

Pitolan is a medicine in tablet form. Two strengths are available: 4.5mg and 18mg. It is currently indicated for the treatment of narcolepsya with or without cataplexyIt is not a first-line treatment. Cataplexy is a sudden relaxation of muscle tone without loss of consciousness. In this indication, pitolinum is reimbursed at 30%.

Contraindications of hypersomnia treatments

Few treatments for hypersomnia are available to date. As the biological mechanism of hypersomnia is not clearly identified, the proposed treatments are only symptomatic. They act on excessive daytime sleepiness. According to the latest consensus conference, 3 molecules are used:

  • the modafinil is the first-line treatment. However, this molecule presents a cardiovascular toxicity. It requires a pre-therapeutic assessment including a ECG (electrocardiogram) and a physical examination. Patients should also have their blood pressure and heart rate monitored quarterly.
  • the methylphenidate is used as a second-line treatment. Its benefit/risk ratio is less good than that of modafinil in terms of cardio-vascularity.
  • l'sodium oxybate has important galenic constraints. Indeed, a first dose must be administered at bedtime and a second one 2.5 to 4 hours later. Its use is also contraindicated in cases of unstabilised psychiatric disorders and sleep apnoea. These two pathologies are often associated with hypersomnia.

The pitolator has different contraindications: it should not be used in cases of severe hepatic insufficiency and in cases of pregnancy and breastfeeding.

Pitolator for resistant or intolerant patients

As we have just seen, certain pathologies prohibit the use of hypersomnia treatments, such as cardiovascular diseases. In addition, modafinil does not work in all patients. However, hypersomnia can have a significant social, family and professional impact. There is therefore a real need for new treatments for this condition.

A study presented in September 2020 to the 25th Congress of the European Sleep Research Society has re-evaluated the value of pitolisant in the treatment of hypersomnia in patients resistant to standard treatments. For the 58 patients who received pitolan for 12 weeks:

  • Sleepiness decreased by 17% (Epworth Sleepiness Rating Scale)
  • Sleep quality increased by 19% (Pittsburgh Sleep Quality Scale)
  • Quality of life increased by 18% (EQ-5D scale).

Pitolates therefore appear to be a genuine therapeutic alternative for patients resistant to the treatments usually used for hypersomnia, but also for those suffering from cardiovascular pathologies.

While the value of pitolates in the treatment of hypersomnia seems very real, let's not forget that non-drug measures are also very important! Some simple recommendations can improve the quality of your sleep!

Stéphanie LG, Doctor of Pharmacy

- Response to pitolisant therapy in patients with difficult to treat hypersomnia, Kaler J.S. et al, J. Sleep Res. Accessed on 8 February.
- Management of patients with hypersomnia: Which strategy? Accessed on 8 February.
- WAKIX (pitolate), histamine H3 receptor antagonist/reverse agonist Accessed on 8 February.

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