Drug Safety Update

Volume 4, Issue 8 March 2011

Latest advice for medicines users

Modafinil (Provigil): information to support safer use; now restricted to narcolepsy

Article date: March 2011
Summary
Following European-wide restriction of use of modafinil to the narcolepsy indication, further information is available to support safer use, including: cautions for use; criteria for stopping treatment; and monitoring requirements during treatment

Modafinil (Provigil) is a wakefulness-promoting agent that acts on the CNS. It is indicated for the treatment of excessive sleepiness in adults with narcolepsy, with or without cataplexy. The recommended starting dose is 200 mg a day.

A recent European review of the benefits and risks of modafinil has recently been completed, and information about the restricted use of this drug as a result of this review was published in the August 2010 issue of Drug Safety Update.

Also as a result of the review, further information and advice is available to support safer use of modafinil.

New information and advice for healthcare professionals:

Product information advises against use in the following groups:

  • Those with uncontrolled hypertension or cardiac arrhythmias
  • Children up to 18 years old
  • Women who are pregnant or breastfeeding

Treatment discontinuation:

  • Modafinil should be discontinued and not restarted in cases of:
    o Serious skin or hypersensitivity reactions
    o Psychiatric disorders such as suicidal ideation

Monitoring during treatment:

  • A baseline electrocardiogram should be done before treatment initiation. Patients with abnormal findings should be further evaluated by specialists before modafinil treatment can be initiated
  • Cardiovascular function—especially blood pressure and heart rate—should be monitored regularly. Modafinil should be discontinued in patients who develop arrhythmia or moderate to severe hypertension, and should not be restarted until the condition has been adequately evaluated and treated

Cautions for use:

  • Modafinil should be used with caution in patients with a history of:
    o Psychosis, depression, or mania
    o Abuse of alcohol, drugs, or illicit substances
  • Such patients should be monitored closely and advised to report any suspected adverse behaviours or thoughts. Patients should be assessed immediately and treatment stopped if appropriate

Advice on treatment cessation

Modafinil is no longer indicated for shift-worker sleep disorder and obstructive sleep apnoea. Patients should be advised to contact their doctor if they are unsure as to whether they should discontinue modafinil treatment. Although there is no need to stop treatment immediately, patients who wish to stop can do so at any time.

Reporting of suspected adverse reactions

Suspected adverse reactions to modafinil should be reported promptly via the Yellow Card Scheme.

Further information:

Letter for healthcare professionals sent January 2011 

BNF section 4.4 CNS stimulants and drugs used for attention deficit hyperactivity disorder

 

Article citation: Drug Safety Update March 2011, vol 4 issue 8: A1.

References

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Page last modified: 03 March 2011