Sodium Butabarbital (Butisol Sodium) as an Hypnotic Agent for Aged Psychiatric Patients With Sleep Disorders*

Abstract

In a triple‐blind, crossover, fixed‐dosage study, sodium butabarbital (Butisol Sodium) was tested as an aid to sleep for 53 hospitalized aged psychiatric patients with sleep disorders. After one week of placebo therapy to detect “placebo reactors,” the additional three‐week schedule (oral administration) consisted of the following sequences: (a) placebo, Butisol 50 mg, Butisol 100 mg; (b) Butisol 50 mg, Butisol 100 mg, placebo; (c) Butisol 100 mg, placebo, Butisol 50 mg. Observations were made at the first two half hours after administration of medication at 8 p.m. and hourly thereafter until 6 a.m., for onset of sleep, duration of sleep, number of times awake, duration of waking period, quality of sleep, and mental state on awakening. Three tests were used for evaluating the patients: CGI, NOSIE and TES. Sodium butabarbital (Butisol Sodium) in moderate dosage (50 mg) was an effective hypnotic agent for the majority of the patients and also appeared to be conducive to behavioral improvement in the daytime as reported by both nurses and psychiatrists. There was no advantage to using the 100‐mg dosage as an hypnotic, and some disadvantage with respect to daytime behavior. Patients slept better and longer during the drug periods than during the placebo periods. There were no more side effects during the drug periods than during the placebo periods, nor were more detrimental effects evident upon awakening. Clearly sodium butabarbital is useful as an hypnotic for aged psychiatric patients.

Systematic 24-hr behavioral observations of sleep and wakefulness in a skilled-care nursing facility.

“…nen, 1980; Pathy, Bayei;& Stoker, 1986;Pattison & Allen, 1972;Stotsky, Cole, Tang, & Gahm, 1971;Viukari, Linnoila, & Aalto, 1978;Viukari & Miettinen, 1984). S/W has also been observed behaviorally in studies of infants (Anders & Keener, 1985;Prechtl, 1974;Thoman, Korner, & Kraemer, 1976), mentally retarded institutionalized children (Landesman-Dwyer, 1976), hospitalized children admitted for elective surgery (Hagemann, 1981), hospitalized psychiatric patients (Kupfer, Detre, & Harrow, 1967;Kupfer, Harrow, & Detre, 1969;Kupfei;Wyatt, & Snyda;1970;Samuel, 1964), intensive care patients (Aurell & Elmqvist, 1985), and even other mammalian species (Bergmann, Rosenberg, Eastman, & Rechtschaffen, 1981;Bergmann, Winter, Rosenberg, & Rechtschaffen, 1987;Dallaire, 1986;Riss & Goodall, 1976).…”

“…Behavioral observations to examine S/W are not unique to this study. A large number of pharmacological trials of hypnotic medications in elderly people have used nursing observations of sleep as at least one dependent variable (e.g., Dehlin, Falkheden, Gatzinska, & Nordqvist, 1978; Exton-Smith, Hodkinson, & Cromie, 1963; Linnoila, Viukari, Numminen, & Auvinen, 1980; Pathy, Bayer, & Stoker, 1986; Pattison & Allen, 1972; Stotsky, Cole, Tang, & Gahm, 1971; Viukari, Linnoila, & Aalto, 1978; Viukari & Miettinen, 1984). S/W has also been observed behaviorally in studies of infants (Anders & Keener, 1985; Prechtl, 1974; Thoman, Korner, & Kraemer, 1976), mentally retarded institutionalized children (Landesman-Dwyer, 1976), hospitalized children admitted for elective surgery (Hagemann, 1981), hospitalized psychiatric patients (Kupfer, Detre, & Harrow, 1967; Kupfer, Harrow, & Detre, 1969; Kupfer, Wyatt, & Snyder, 1970; Samuel, 1964), intensive care patients (Aurell & Elmqvist, 1985), and even other mammalian species (Bergmann, Rosenberg, Eastman, & Rechtschaffen, 1981; Bergmann, Winter, Rosenberg, & Rechtschaffen, 1987; Dallaire, 1986; Riss & Goodall, 1976).…”

CNS Adverse Effects: From Functional Observation Battery/Irwin Tests to Electrophysiology

“…Drug-induced sleep disruption has been well documented since the introduction of barbiturates as hypnotics in the 1970s (Stotsky et al 1971). From a drug-safety perspective, the main concern with drug-induced sleep disruption is the consequent daytime drowsiness that follows, which in turn may lead to increased risk of workor driving-related accidents.…”