Anti-sleeping drug restricted to narcolepsy patients

4th March 2011 - The medicines regulator MHRA has issued new drug safety advice restricting the use of the anti-sleeping drug modafinil (Provigil) to patients suffering from narcolepsy.

The treatment had been used for sleep apnoea, MS and ADHD in the past.

Narcolepsy is a chronic sleep disorder, which for some people involves falling asleep suddenly, without warning. It is estimated to affect 25,000 people in the UK - but most people who suffer from it are undiagnosed.

Modafinil (Provigil) is a wakefulness-promoting agent that acts on the body’s central nervous system.

New restrictions

A recent European review of the benefits and risks of modafinil has recently been completed, and information about the restricted use of this drug has been issued by the MHRA as a result of this review.

The European review found that the risk of adverse effects, including psychiatric and serious skin reactions, and the potential for cardiovascular adverse effects, outweighed the benefits in using modafinil in treating conditions other than narcolepsy.

Modafinil should no longer be used for shift-worker sleep disorder and obstructive sleep apnoea.

Patients should contact their doctor about alternative treatments.

Although there is no need to stop treatment immediately, the MHRA says patients who wish to stop can do so at any time.

The new 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

Modafinil should be discontinued and not restarted in cases of:

• Serious skin or hypersensitivity reactions
• Psychiatric disorders such as suicidal ideation

Monitoring during treatment

An electrocardiogram should now be done before treatment is started. 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.

Modafinil should be used with caution in patients with a history of:

• Psychosis, depression, or mania
• Abuse of alcohol, drugs, or illegal drugs or 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.