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Clin Drug Investig. 2003;23(6):351-85.

Consensus on drug treatment, definition and diagnosis for insomnia.

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  • 1Unidad de Trastornos de Sueño, Instituto Universitario Dexeus, Barcelona, Spain.


Thirty-four experts and a literature supervisor got together in order to reach a 'consensus' regarding the definition, diagnosis and pharmacological treatment of insomnia. Insomnia is a subjective perception of dissatisfaction with the amount and/or quality of sleep. It includes difficulty in initiating or maintaining sleep or early awakening with inability to fall asleep again. It is associated with complaints of non-restorative sleep and dysfunction of diurnal alertness, energy, cognitive function, behaviour or emotional state, with a decrease in quality of life. The diagnosis is based on clinical and sleep history, physical examination and additional tests, although polysomnography is not routinely indicated. Therapy should include treatment of the underlying causes, cognitive and behavioural measures and drug treatment. Hypnotic therapy can be prescribed from the onset of insomnia and non-benzodiazepine selective agonists of the GABA-A receptor complex are the drugs of first choice. It is recommended that hypnotic treatment be maintained in cases where withdrawal impairs the patient's quality of life and when all other therapeutic measures have failed. Experience suggests that intermittent treatment is better than continuous therapy. The available data do not confirm safety of hypnotics in pregnancy, lactation and childhood insomnia. Benzodiazepines are not indicated in decompensated chronic pulmonary disease but no significant adverse effects on respiratory function have been reported with zolpidem and zopiclone in stable mild to moderate chronic obstructive pulmonary disease and in treated obstructive sleep apnoea syndrome. Data for zaleplon are inconclusive. If the patient recovers subjective control over the sleep process, gradual discontinuation of hypnotic treatment can be considered.

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