Curr Med Res Opin Downloaded from informahealthcare.com by University of Newcastle Upon Tyne on 12/19/14 For personal use only.
Current Medical Research and Opinion
Vol. 12, No. 6, 1YY1
Temazepam ‘Planpak’,a fixeddose reduction regimen for withdrawing benzodiazepine hypnotics: results of a general practice survey
J. Drake, M.B., Ch.B.
Curr. Med. Res. Opin.. (1Y91). 12,394.
Medical Department, Fnrmitalia Carlo Erba Ltd., St. Albans, England
Received: 30th January 1991
Summary In a general practice survey of the use of Temazepam ‘Planpak’(‘Planpak 7, 31 participating doctors completed questionnaires on 250 patients. Of these, 228 patients had been taking a variety of 8 benzodiazepine hypnotics prior to ‘Planpak ’therapy while 22 (8.8yo)patients received ‘Planpak’asa short course, without prior hypnotic therapv. Of the patients being weaned off benzodiazepines with ‘Planpak the majority had been on therapy ,for longer than I year (mean .5.36-+5.58 years, range 0.08 to 22.9 years). Success (68%) or partial success (13%) was achieved in 8I% of patients (YS% confidence interval 77% to 86%) in terms of’ total abstinence from or reduced use of hypnotic fo r at least 1 month after ‘Planpak‘ therapy. Outcome was not related statistically to gendel; type, or duration of previous hypnotic therapy. Twenty-six patients received from one to three additional courses of ‘Planpak ’ and I77 (71%) were not taking hypnotics at the time ofthe survey which represented a mean follow-up of 9.1 y-15.36 months (range I . 7 to 36.5 months). Key words: Temazepam questionnaire
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benzodiazepines - drug withdrawal symptoms -
Introduction The risk of benzodiazepine dependence at therapeutic doses is now widely accepted and a withdrawal syndrome can occur in approximately 30% to 45% of patients who stop treatment abruptly.” The U.K. Committee on Safety of Medicines and the Royal College of Psychiatrists have published separately recommendations for limiting the use of benzodiazepines as anxiolytics and hypnotics and for tapering off the dose at the end of treatment.’ l o Both recommendations caution the use of benzodiazepines for sleep induction and recommend treatment of the underlying causes before resorting to medication which, if prescribed, should be for short periods and only when symptoms are severe, disabling or causing extreme distress. Despite the publicity, temazepam, a benzodiazepine indicated only for hypnosis, is still widely prescribed. In 1989 there were 6.632 million prescriptions for temazepam in the United Kingdom of which about 80%were repeats and it is estimated that over 1 million patients have been taking temazepam for longer than 1 year. Although it is recommended that patients should be weaned off benzodiazepines graduallythere is no consensus on the time necessary for withdrawal or the optimal Correspondence to: Dr. John Drake, Medical Director, Farmitalia Carlo Erba (U.K.) Ltd., Italia House, 23 Grosvenor Road, St. Albans, Herts AL13AW, England 394
Curr Med Res Opin Downloaded from informahealthcare.com by University of Newcastle Upon Tyne on 12/19/14 For personal use only.
J. Drake
dose reductions at each step.4 Four weeks have been suggested as the minimum period, but programmes of 16 weeks have been r e c ~ m m e n d e d . ~ Temazepam ‘Planpak’ (‘Planpak’) is the only pre-packed fixed dose reduction regimen available in the United Kingdom. It provides three different dosages of temazepam, in capsule form, and allows a 6-week course of treatment in which the dose of temazepam is reduced from 10 mg through 5 mg to 2 mg, each dose being taken for 2 weeks. ‘Planpak’ is indicated either as a means of tapering off the dose of temazepam at the end of treatment o r as a short-term course of therapy for sleep disturbances in patients at risk of dependence. Since its introduction in 1987, approximately 70,000 patients have been treated with the ‘Planpak’ regimen. This general practice survey was carried out to determine the proportions which each indication contribute to the total use of ‘Planpak’ and to assess the overall success rate which can be expected.
Patients and methods The survey started in April 1989 and finished in February 1990. A letter inviting participation in the survey was sent to 122 general practitioners previously identified as having prescribed ‘Planpak’ and to 101 who were randomly selected from a list of U.K. practices published by Walsh Marketing Systems Ltd. Those who agreed to take part were asked to indicate the number of patients they had treated in the past and for whom data would be available. They were then sent one questionnaire per patient. The questionnaire consisted of 6 parts designed to provide information on the name and duration of use of t h e hypnotic which was to be withdrawn, the immediate outcome of ‘Planpak’ therapy, details of additional courses of ‘Planpak’ if given and the hypnotic status at the time of the questionnaire. Immediate outcome of ‘Planpak’ therapy was defined as either successful, partially successful or unsuccessful. A successful outcome was scored when no further pharmacological hypnotic therapy had been given for at least 1 month after the end of the course of ‘Planpak’. Partial success was achieved if the patient still required an hypnotic intermittently and/or at a reduced dose. Statistical analysis of the differences between male and female patients for age and duration of hypnotic therapy was performed using one-way analysis of variance. A life table analysis was performed to estimate the number of patients hypnotic-free at various times after completing ‘Planpak’ therapy.
Results There were 250 questionnaires completed by 31 participating doctors. Only 4 of the doctors randomly selected from the Walsh list participated. The demographic data of the patients are included in Table I. There were 1.8 times as many females as males and the female group was significantly older (p
Current Medical Research and Opinion
Vol. 12, No. 6, 1YY1
Temazepam ‘Planpak’,a fixeddose reduction regimen for withdrawing benzodiazepine hypnotics: results of a general practice survey
J. Drake, M.B., Ch.B.
Curr. Med. Res. Opin.. (1Y91). 12,394.
Medical Department, Fnrmitalia Carlo Erba Ltd., St. Albans, England
Received: 30th January 1991
Summary In a general practice survey of the use of Temazepam ‘Planpak’(‘Planpak 7, 31 participating doctors completed questionnaires on 250 patients. Of these, 228 patients had been taking a variety of 8 benzodiazepine hypnotics prior to ‘Planpak ’therapy while 22 (8.8yo)patients received ‘Planpak’asa short course, without prior hypnotic therapv. Of the patients being weaned off benzodiazepines with ‘Planpak the majority had been on therapy ,for longer than I year (mean .5.36-+5.58 years, range 0.08 to 22.9 years). Success (68%) or partial success (13%) was achieved in 8I% of patients (YS% confidence interval 77% to 86%) in terms of’ total abstinence from or reduced use of hypnotic fo r at least 1 month after ‘Planpak‘ therapy. Outcome was not related statistically to gendel; type, or duration of previous hypnotic therapy. Twenty-six patients received from one to three additional courses of ‘Planpak ’ and I77 (71%) were not taking hypnotics at the time ofthe survey which represented a mean follow-up of 9.1 y-15.36 months (range I . 7 to 36.5 months). Key words: Temazepam questionnaire
-
benzodiazepines - drug withdrawal symptoms -
Introduction The risk of benzodiazepine dependence at therapeutic doses is now widely accepted and a withdrawal syndrome can occur in approximately 30% to 45% of patients who stop treatment abruptly.” The U.K. Committee on Safety of Medicines and the Royal College of Psychiatrists have published separately recommendations for limiting the use of benzodiazepines as anxiolytics and hypnotics and for tapering off the dose at the end of treatment.’ l o Both recommendations caution the use of benzodiazepines for sleep induction and recommend treatment of the underlying causes before resorting to medication which, if prescribed, should be for short periods and only when symptoms are severe, disabling or causing extreme distress. Despite the publicity, temazepam, a benzodiazepine indicated only for hypnosis, is still widely prescribed. In 1989 there were 6.632 million prescriptions for temazepam in the United Kingdom of which about 80%were repeats and it is estimated that over 1 million patients have been taking temazepam for longer than 1 year. Although it is recommended that patients should be weaned off benzodiazepines graduallythere is no consensus on the time necessary for withdrawal or the optimal Correspondence to: Dr. John Drake, Medical Director, Farmitalia Carlo Erba (U.K.) Ltd., Italia House, 23 Grosvenor Road, St. Albans, Herts AL13AW, England 394
Curr Med Res Opin Downloaded from informahealthcare.com by University of Newcastle Upon Tyne on 12/19/14 For personal use only.
J. Drake
dose reductions at each step.4 Four weeks have been suggested as the minimum period, but programmes of 16 weeks have been r e c ~ m m e n d e d . ~ Temazepam ‘Planpak’ (‘Planpak’) is the only pre-packed fixed dose reduction regimen available in the United Kingdom. It provides three different dosages of temazepam, in capsule form, and allows a 6-week course of treatment in which the dose of temazepam is reduced from 10 mg through 5 mg to 2 mg, each dose being taken for 2 weeks. ‘Planpak’ is indicated either as a means of tapering off the dose of temazepam at the end of treatment o r as a short-term course of therapy for sleep disturbances in patients at risk of dependence. Since its introduction in 1987, approximately 70,000 patients have been treated with the ‘Planpak’ regimen. This general practice survey was carried out to determine the proportions which each indication contribute to the total use of ‘Planpak’ and to assess the overall success rate which can be expected.
Patients and methods The survey started in April 1989 and finished in February 1990. A letter inviting participation in the survey was sent to 122 general practitioners previously identified as having prescribed ‘Planpak’ and to 101 who were randomly selected from a list of U.K. practices published by Walsh Marketing Systems Ltd. Those who agreed to take part were asked to indicate the number of patients they had treated in the past and for whom data would be available. They were then sent one questionnaire per patient. The questionnaire consisted of 6 parts designed to provide information on the name and duration of use of t h e hypnotic which was to be withdrawn, the immediate outcome of ‘Planpak’ therapy, details of additional courses of ‘Planpak’ if given and the hypnotic status at the time of the questionnaire. Immediate outcome of ‘Planpak’ therapy was defined as either successful, partially successful or unsuccessful. A successful outcome was scored when no further pharmacological hypnotic therapy had been given for at least 1 month after the end of the course of ‘Planpak’. Partial success was achieved if the patient still required an hypnotic intermittently and/or at a reduced dose. Statistical analysis of the differences between male and female patients for age and duration of hypnotic therapy was performed using one-way analysis of variance. A life table analysis was performed to estimate the number of patients hypnotic-free at various times after completing ‘Planpak’ therapy.
Results There were 250 questionnaires completed by 31 participating doctors. Only 4 of the doctors randomly selected from the Walsh list participated. The demographic data of the patients are included in Table I. There were 1.8 times as many females as males and the female group was significantly older (p
