A randomized clinical trial comparing doses and efficacy of lormetazepam tablets or oral solution for insomnia in a general practice setting
| Autor: | Joëlle Micallef, C Ancolio, S. Tardieu, C. Alquier, Vincent Pradel, O. Blin, C Soubrouillard |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.drug_class Administration Oral Lorazepam law.invention Hypnotic Randomized controlled trial law Sleep Initiation and Maintenance Disorders medicine Insomnia Humans Pharmacology (medical) Analysis of Variance Benzodiazepine business.industry Lormetazepam Middle Aged Effective dose (pharmacology) Clinical trial Pharmaceutical Solutions Psychiatry and Mental health Neurology Anesthesia Female Neurology (clinical) medicine.symptom Family Practice business Tablets medicine.drug |
| Zdroj: | Human Psychopharmacology: Clinical and Experimental. 19:129-134 |
| ISSN: | 1099-1077 0885-6222 |
| DOI: | 10.1002/hup.572 |
| Popis: | Lormetazepam is a short-acting benzodiazepine hypnotic which is beneficial in shortening the time to onset of sleep. The aim of the study was to assess a new formulation of lormetazepam (oral solution) in comparison with lormetazepam tablets in out-patients with insomnia. This trial was an open randomized parallel group study conducted by 30 general practitioners. One hundred and eight patients took 0.5 mg on the first night and were allowed to increase their dosage by 0.25 mg (for oral solution) and 0.5 mg (for tablets), respectively, each day and every 2 days. The patients assessed the efficacy, acceptability and tolerance of lormetazepam using a diary card and a set of visual analogue scales assessing their sleep. Over 14 days of treatment, the mean daily dose of lormetazepam was lower in the oral solution group than in the tablets group (0.78 mg versus 0.97 mg). The cumulated dose of lormetazepam was lower with the oral solution (18% reduction). No significant difference between the two groups was found in the assessment of sleep characteristics. The occurrence of side effects did not differ between the two groups. These results suggest that a unitary dose as achieved by an oral solution of lormetazepam allows easier determination of the minimal individual effective dose. |
| Databáze: | OpenAIRE |
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