Side Effects of Zolpidem and Temazepam in Treating Primary Insomnia V

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Side effects of zolpidem and temazepam in treating primary insomnia V. Janjic1, B. Radmanovic1, S. Djukic Dejanovic1, D. Ravanic1, M. Borovcanin1. 1Clinical Center Kragujevac, Dept. of Psychiatric Clinic, Kragujevac, Serbia.

Objective of the research was to establish the number and intensity of side effects of zolpidem and temazepam during a three-week treatment of primary insomnia.

The patients that were diagnosed with primary insomnia based on DSM-IV-TR criteria were included in this research. Only patients that didn't have other mental disorders and somatic illnesses, and that didn't use any other medications besides the one investigated were included in the research. Total number of examinees was 47, and after randomization they were divided in two groups. The first group included 23 examinees that were receiving 10 mg of non-benzodiazepine hypnotic zolpidem before bedtime during the three-week treatment. The second group included 24 patients with primary insomnia that were receiving 15 mg of benzodiazepine hypnotic temazepam before bedtime during the three-week treatment. Every side effect was established and overviewed both quantitatively and qualitatively. Establishing and assessment of side effects in both groups of examinees was conducted at the beginning of the treatment, after a week, after two weeks, and in the end of a three-week treatment. At weekly visits, all patients were given upfront the list of most common side effects, in order to record single side effects. Intensity of single side effects established was assessed with Visual Analogue Scale (VAS) of 100mm.

The results obtained were statistically processed and shown through total number of side effects, total intensity of side effects and intensity per side effect. Our results show that on base visit there was no difference in expressing the side effects between the groups investigated. Given the fact that administration of medications was just initiated at this visit, we can say that according to this parameter the groups investigated were homogeneous. Quantitative and qualitative analysis of side effects during the course of investigation had shown that the group of examinees who received zolpidem had statistically significantly lower total number of side effects (U=82; p=0,001), lower intensity on VAS scale of side effects (U=58,5; p<0,002), and lower intensity per single side effect (U=45; p<0,008) compared to the group that received temazepam. In over 10% of examinees in both groups we recorded side effects, asthenia/fatigue, solicitude, headache, concentration weakness, with significantly lower presence and lower intensity in zolpidem group. Results also show that during the first week of the treatment previously listed side effects were also the most common ones and the ones with greatest intensity, and they also show that as time goes during the treatment there is a decrease of their number and intensity in both groups of examinees. None of the established side effects was the reason to cease treatment or reduce dose.

ADVERSE EVENTS IN BOUTH GROUPS Intensity zolpidem temazepam asthenia/fatigue ↓ ↑ solicitude ↓ ↑ headache ↓ ↑ concentration weakness ↓ ↑

Based on our results we can conclude that the number and intensity of side effects during the three-week treatment of primary insomnia was significantly reduced, but in the end of treatment it was significantly lower in persons treated with zolpidem compared to those treated with temazepam.

Reference(s) [1] Holm KJ, Goa KL. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs 2000; 59: 865-89. [2] Leppik IE, Roth-Schechter GB, Gray GW et al. Double-Blind, Placebo-Controlled Comparison of Zolpidem, Triazolam, and Temazepam in Elderly Patients With Insomnia. Drug Development Research 1997; 40:230–238. [3] Partinen M, Hirvonen K, Hublin C, Halavaara M, Hiltunen H. Effects of after-midnight intake of zolpidem and temazepam on driving ability in women with non-organic insomnia. Sleep Medicine 2003; 4: 553–561. P.8.b.006 Side effects of zolpidem and temazepam in treating primary insomnia V. Janjic1, B. Radmanovic1, S. Djukic Dejanovic1, D. Ravanic1, M. Borovcanin1 1Clinical Center Kragujevaca Dept. of Psychiatric Clinica Kragujevaca Serbia

Objective of the research was to establish the number and intensity of side effects of zolpidem and temazepam during a three-week treatment of primary insomnia.

The patients that were diagnosed with primary insomnia based on DSM-IV-TR criteria were included in this research. Only patients that didn't have other mental disorders and somatic illnesses, and that didn't use any other medications besides the one investigated were included in the research. Total number of examinees was 47, and after randomization they were divided in two groups. The first group included 23 examinees that were receiving 10mg of non-benzodiazepine hypnotic zolpidem before bedtime during the three-week treatment. The second group included 24 patients with primary insomnia that were receiving 15mg of benzodiazepine hypnotic temazepam before bedtime during the three-week treatment. Every side effect was established and overviewed both quantitatively and qualitatively. Establishing and assessment of side effects in both groups of examinees was conducted at the beginning of the treatment, after a week, after two weeks, and in the end of a three-week treatment. At weekly visits, all patients were given upfront the list of most common side effects, in order to record single side effects. Intensity of single side effects established was assessed with Visual Analogue Scale (VAS) of 100mm. The results obtained were statistically processed and shown through total number of side effects, total intensity of side effects and intensity per side effect.

Our results show that on base visit there was no difference in expressing the side effects between the groups investigated. Given the fact that administration of medications was just initiated at this visit, we can say that according to this parameter the groups investigated were homogeneous. Quantitative and qualitative analysis of side effects during the course of investigation had shown that the group of examinees who received zolpidem had statistically significantly lower total number of side effects (U=82; p=0.001), lower intensity on VAS scale of side effects (U=58.5; p<0.002), and lower intensity per single side effect (U=45; p<0.008) compared to the group that received temazepam. In over 10a of examinees in both groups we recorded side effects, asthenia/fatigue, solicitude, headache, concentration weakness, with significantly lower presence and lower intensity in zolpidem group. Results also show that during the first week of the treatment previously listed side effects were also the most common ones and the ones with greatest intensity, and they also show that as time goes during the treatment there is a decrease of their number and intensity in both groups of examinees. None of the established side effects was the reason to cease treatment or reduce dose.

1. Holm KJ, Goa KL. Zolpidem: an update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs 2000; 59: 865–89.

2. Leppik IE, Roth-Schechter GB, Gray GW et al. Double-Blind, Placebo-Controlled Comparison of Zolpidem, Triazolam, and Temazepam in Elderly Patients With Insomnia. Drug Development Research 1997; 40:230–238.

3. Partinen M, Hirvonen K, Hublin C, Halavaara M, Hiltunen H. Effects of after-midnight intake of zolpidem and temazepam on driving ability in women with non-organic insomnia. Sleep Medicine 2003; 4: 553–561.

Citation: Eur Neuropsychopharmacol. 2014;24aSuppl 2):S737

Keywords Sleep disorders Benzodiazepines Drug monitoring