A comparison of the effects of zolpidem and placebo on respiration and oxygen saturation during sleep in the healthy elderly.

Abstract

1 In a double-blind placebo controlled trial, zolpidem 10 mg, a new imidazopyridine hypnotic drug, was administered to 10 elderly female patients and placebo to 11, all recovering from hip and knee replacement surgery. Respiratory monitoring with an inductance plethysmograph and pulse oximeter showed that treatment over a 4 night period did not increase significantly the severity, frequency or duration of hypoxaemic episodes leading to SaO2 < 90% or < 85% when compared with placebo. Confidence intervals (corrected for baseline differences) for the median differences between the two groups on night 7, the fourth night of treatment, were from -1.85 to 0.480 and from -1.07 to 0 respectively for the frequency, and from -0.76 to 0.15 and -0.5 to 0 for the duration of the hypoxaemic episodes. The incidence of sleep related respiratory disturbances was not significantly increased compared with placebo on any night. 2 Respiratory monitoring using a simple inductance plethysmograph and pulse oximeter is acceptable to patients and staff. 3 The evaluation of all hypnotic and sedative drugs should include their effects on respiration during sleep.

The safety and tolerability of zolpidem — an update

“…In healthy volunteers, zolpidem 10 or 20 mg/day did not signi®cantly alter respiratory parameters (Davenne et al, 1991;Maillard et al, 1992). Using a double-blind design comparing zolpidem 10 mg and placebo, in 21 postoperative elderly females without lung disease over a 4-night period, Rhodes et al (1990) did not ®nd any signi®cant increase in the frequency or severity of sleep-related breathing disorders, such as modi®cation in respiratory rhythms and oxygen saturation. However, the author notes that sleep-related respiratory disturbances are more common in men and that further study of zolpidem should be carried out in a male population.…”

“…None of the drugs signi®cantly affected arterial O 2 saturation (SaO 2 ), the apnoea±hypopnoea index, or heart rate. However, in some patients, there were Scharf (1991a) Elderly healthy volunteers DB/CO/Pla 33 Zol 5±20 mg 2 Elderly chronic insomnia DB/PG/Pla 111 Zol 10±30 mg/Tria 0.25 mg 1 Rhodes (1990) Elderly healthy volunteers DB/PG/Pla 21 Zol 10 mg 1 Fairweather (1992) Elderly healthy volunteers DB/CO/Pla 24 Zol 5, 10 mg 7 Roger (1993) Elderly chronic insomnia DB/PG/Tria 221 Zol 5, 10 mg/Tria 0.25 mg 21 Shaw (1992) Chronic insomnia DB/PG 119 Zol 10, 20 mg 21 Ochs (1992a) Chronic insomnia DB/PG/Pla 335 Zol 5 mg/Tria 0.125 mg/Tema 15 mg 28 Benoit (1994) Elderly healthy volunteers DB/CO/Pla 11 Zol 10 mg 21 Emeriau (1988) Elderly chronic insomnia DB/PG 84 Zol 10, 20 mg/Fluni 1 mg 28 Cohn (1994) Elderly chronic insomnia DB/PG/Pla 335 Zol 5, 10 mg/Tria 0.125 mg 28 Tema 15 mg Kummer (1993) Elderly chronic insomnia SB 14 Zol 20 mg 180 Sauvanet (1988) Elderly chronic insomnia Open 42 Zol 10, 20, 30 mg 60±360 DB, Double blind; PG, parallel groups; SB, single blind; CO, crossover; Zol, zolpidem; Tema, temazepam; Tria, triazolam; Fluni,¯unitrazepam. Adapted with permission from Allain (1997).…”

Effects of zolpidem on sleep architecture, night time ventilation, daytime vigilance and performance in heavy snorers.

“…A study monitoring respiration with a simple inductance plethysmograph and oximetry was carried out in a group of 10 elderly female patients recovering from hip and knee replacement surgery, to evaluate the respiratory effects of zolpidem 10 mg taken over 4 nights [34]. The elderly are known to be a population with a higher risk of sleep related respiratory disturbances [35,36].…”

Pharmacologic Treatment of Disturbed Sleep in the Elderly

“…31 Zolpidem also did not, when compared to triazolam, impair reaction time, tracking, memory scanning, or word recognition in doses of 5 to 10 mg for seven days in 24 healthy elderly volunteers 32 and did not, relative to placebo, increase respiratory disturbances during sleep. 33 An extended-release form of zolpidem is also available; relative to placebo, a dose of 6.25 mg significantly decreased wake time after sleep onset during the first six hours of the night as measured by a polysomnogram. 34 Zaleplon, a second benzodiazepine hypnotic receptor agonist that acts at the benzodiazepine receptor type I site of the GABA-A receptor complex, has been studied in elderly outpatients with primary insomnia.…”