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News1993December › Ec restrictions on sleeping pills › December 1993

Ec restrictions on sleeping pills

The EC's Committee for Proprietary Medicinal Products is recommending new prescribing restrictions on seven short acting sleeping pill/tranquillizers, including Halcion (triazolam)

The EC's Committee for Proprietary Medicinal Products is recommending new prescribing restrictions on seven short acting sleeping pill/tranquillizers, including Halcion (triazolam).

These recommendations follow a two year study into the products, prompted by the UK's ban on the use of Halcion.

The study, which examined brotizolam, flunitrazepam, midazolan, temazepam (Valium), zolpidem and zoplicone, concluded that all seven should only be used when insomia is "severe, disabling or subjecting the individual to extreme distress".

The committee set a limit for usage of between a few days and two weeks, with a maximum of four weeks including a tapering off period for four drugs: flunitra-zepam, temazepam, zoplicone and zolpidem.

The other three, including Halcion, were given a more severe restriction of a maximum of two weeks, with tapering off tailored to the individual's needs.

The report also said that all seven drugs should never be given to patients with myasthenia gravis (abnormally weak muscles), hypersensitivity to benzodiazepines, severe respiratory insufficiency, problems with breathing during sleep, and severe liver insufficiency. They should also never be given to children.


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