Modafinil

Amber

Brand Name(s):Provigil

Indication:Excessive sleepiness associated with narcolepsy with or without cataplexy

Rationale:1,2

Considered:Nov-09

Review Date:Jul-23

Comments:
Refer to SCP
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http://www.nice.org.uk/mpc/evidencesummariesunlicensedofflabelmedicines/ESUOM9.jsp
ESU0M9 April 2013
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The European Medicines Agency has recommended that the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy, and that it should no longer be used for the treatment of excessive sleepiness associated with obstructive sleep apnoea or chronic shift work sleep disorder.
On the basis of the available data, the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication narcolepsy. For all other indications the Committee found that the risks outweighed the
benefit shown in clinical trials. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines.
MHRA Drug Safety Update Volume 4, Issue 1 August 2010
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The MHRA Drug Safety Update has issued a reminder advising that modafinil should be withdrawn in patients who experience a rash or psychiatric symptoms, and makes the following recommendations:
* Modafinil should be discontinued at the first sign of rash and not restarted
* Modafinil should be discontinued in patients who experience any psychiatric symptoms and not restarted *Update 2020* Letter sent to Healthcare Professionals – Modafinil: potential risk of congenital malformations during pregnancy