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PubMedDate not supplied

Clinical trial with a new substance (PLP 100-127) in order to asses therapeutic efficacy and dependence creating properties.

The objectives of the study have been to evaluate the therapeutic efficacy of PLP 100-127 (6-(4-methyl-l-piperazinyl) morphanthridin) on patients with moderate to severe insomnia, to evaluate safety and tolerance of the drug and to investigate whether or not the drug may have dependence producing properties through the possible development of mental and/or physical dependence. A clinical-therapeutical long-term comparsion as a double blind cross-over investigation between PLP 100-127 and nitrazepan is presented. 30 patients at Gaustad hospital, mainly long-term patients with the diagnosis of schizophrenia, were selected for the trial, which lasted for 38 weeks. There were 9 drop outs, mainly due to relapse of psychotic symptoms. PLP 100-127 seems to have a favorable effect on moderate and severe insomnia in patients suffering from severe mental diseases. It seems to be well tolerated in these groups of patients. No signs of dependence producing properties have been observed by the observation method here presented.

Adult↗
PubMed2004

Randomized controlled trial of brief cognitive-behavioural interventions for insomnia in recovering alcoholics.

AIMS: To test the efficacy of a cognitive-behavioural approach to treating disturbed sleep in abstinent alcoholics. DESIGN: Sixty recovering alcoholics with insomnia were assigned randomly to individual therapy, self-help with telephone support or waiting-list control. SETTING: Participants were volunteers recruited from out-patient treatment programs and through the media. MEASUREMENTS: Outcomes were assessed at post-treatment, 3-month and 6-month follow-ups using sleep diaries, the Pittsburgh Sleep Quality Index, wrist actigraphs and time-line follow-back interviews. INTERVENTION: Five sessions of out-patient cognitive-behavioural therapy for insomnia or a self-help manual with five telephone support calls. Treatment duration was 7 weeks. FINDINGS: Treated participants were significantly more improved than control participants on diary measures of sleep quality, sleep efficiency, awakenings and time to fall asleep. No significant differences between the individual therapy and self-help treatment conditions on measures of insomnia severity were evident at post-treatment. Self-reported improvement in sleep was corroborated by clinician and spousal ratings of insomnia severity, but not by actigraph recordings of nocturnal activity. At 3- and 6-month follow-up assessments treatment gains were reasonably maintained in both treatment groups, although individual therapy was associated with a higher rate of clinically significant improvement. At the 6-month follow-up, 60% participants who were regular users of sedative medication at baseline discontinued the use of their medication. Treatment appeared to have little impact in preventing relapses to alcohol. CONCLUSIONS: Recovering alcoholics with insomnia can achieve better sleep by applying cognitive-behavioural strategies.

Adolescent↗
PubMed1977

Single-blind evaluation of hypnotic activity of chlordesmethyldiazepam in No-placebo-reactor medical patients.

69 patients hospitalized for chronic respiratory diseases and complaining of moderate to severe insomnia were treated with placebo for 2 days, 36 subjects (52.17%) were discarded for their placebo responsiveness. To the remaining patients who suffered from severe insomnia, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one (chlordesmethyldiazepam, 2 mg orally) was administered for 7 consecutive evenings. The onset, duration, quality of sleep and the state on awakening were scored on the basis of patient subjective measurements. High scores of the four considered parameters were obtained during chlordesmethyldiazepam administration. Three treated patients complained of diurnal drowsiness. Results are discussed with regard to methodological problems in the evaluation of hypnotics.

Clinical Trials as Topic↗
PubMed2006

Nasal dilator strip therapy for chronic sleep-maintenance insomnia and symptoms of sleep-disordered breathing: a randomized controlled trial.

To test the impact of nasal dilator strips (NDSs) on insomnia severity, sleep-disordered breathing (SDB) symptoms, sleep quality, and quality of life. Randomized, controlled trial of 4 weeks' duration. Community sample of nonobese, adults with a primary sleep complaint of chronic sleep-maintenance insomnia and mild to moderate SDB symptoms (treatment, n=42; control, n=38). Primary outcomes were four validated scales: Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Questionnaire (FOSQ), and Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). Secondary outcomes were sleep indices, nonrestorative sleep ratings, and SDB symptoms, assessed retrospectively and prospectively. Both groups received nonspecific education about sleep disorders. Treatment group also received a brief SDB education and nasal strip instructions. At 4 weeks' follow-up, the treatment group demonstrated significant (p=.0001), large improvements in ISI and PSQI (mean Cohen's d=1.18) and significant (p<.02), medium-sized improvements in FOSQ and QLESQ (mean d=0.51) compared to small, nonsignificant changes in control group (Cohen's d range=0.36-0.09). Treatment group change scores among all four primary variables were significantly correlated (mean r=0.50, p=0.01). Secondary prospective and retrospective outcomes showed medium to large improvements in treatment compared to controls for sleep indices (mean d=0.52 vs 0.28), nonrestorative sleep ratings (mean d=0.69 vs 0.11), and sleep breathing symptoms (mean d=0.47 vs 0.09). Significance was obtained for prospective sleep indices (p=0.01), retrospective, and prospective nonrestorative sleep ratings (p=0.003, <0.05), and retrospective sleep breathing symptoms (p=0.03). SDB education and NDSs demonstrated therapeutic efficacy in a select sample of insomnia patients with SDB symptoms. Replication of results requires placebo controls and objectively confirmed SDB cases.

Chronic Disease↗
PubMed2002

Substance use for insomnia in Metropolitan Detroit.

OBJECTIVE: People with insomnia are not typically treated medically for their insomnia. Studies have reported approximately 30% of insomniacs self-medicate with alcohol or over-the-counter (OTC) medications. This study was done to identify determinants and risks of different insomnia therapeutics. METHODS: A random-digit-dial, computer-assisted survey of a representative sample of adults in Metropolitan Detroit, aged 18-65 years, is being conducted. A sample of all respondents over an 18-month period was collected (n=1324) with a 68% response rate. Exclusive past-year use of alcohol for sleep was reported by 10% (n=132), prescription medications by 8% (n=108), and OTC medications by 10% (n=135). Five percent used both alcohol and sleep medications. The three exclusive-use groups formed the comparison groups of the study. RESULTS: The prescription drug group used medications for more consecutive nights and for more total nights than the alcohol and OTC users. Alcohol users were predominantly male, while OTC and prescription drug users were predominantly female. Alcohol users were more likely to be single than the others, and prescription drug users were older than the others. Prescription drug users had more severe insomnia and had greater disability, neuroticism, and daytime fatigue than the others. In contrast, the alcohol users had greater daytime sleepiness than the others. CONCLUSIONS: In Metropolitan Detroit, insomniacs receiving medical treatment have more severe insomnia and greater disability than those who self-treat. However, while the insomnia of those self-treating is less severe, it is still associated with some risks.

Adolescent↗
PubMed1996

Long-term, nightly benzodiazepine treatment of injurious parasomnias and other disorders of disrupted nocturnal sleep in 170 adults.

PURPOSE: To assess the efficacy, dose stability, safety, and abuse potential of long-term, nightly benzodiazepine treatment of chronic disorders of disrupted nocturnal sleep. PATIENTS AND METHODS: During a 12-year period, one author evaluated and treated 170 adult referrals for > or = 6 months with nightly benzodiazepine therapy for longstanding, sleep-disruptive disorders: injurious sleepwalking and sleep terrors (69); rapid eye movement sleep behavior disorder (52); chronic, severe insomnia (25); and restless legs syndrome/periodic limb movement disorder (24). RESULTS: Complete/substantial control of the sleep disorders was achieved by 146 patients (86%); 8% had adverse effects requiring medication changes; 2% had relapses of alcohol or chemical abuse requiring hospitalization; another 2% at times misused their medications. A total of 136 patients received clonazepam nightly for a mean 3.5 (+/- 2.4) years, with no significant difference in inital versus final mean dose: 0.77 mg (+/- 0.46) versus 1.10 mg (+/- 0.96). Similar results were obtained with chronic alprazolam treatment and with other benzodiazepine treatments. CONCLUSION: Long-term, nightly benzodiazepine treatment of injurious parasomnias and other disorders of disrupted nocturnal sleep resulted in sustained efficacy in most cases, with low risk of dosage tolerance, adverse effects, or abuse. Data from this study on the treatment of chronic, severe insomnia (a small subset of all insomnia) are not generalizable to the typical insomnia patient.

Adult↗
PubMed1986

Evaluation of L-tryptophan for treatment of insomnia: a review.

Sleep laboratory and outpatient studies of the hypnotic efficacy of the amino acid L-tryptophan are reviewed, with particular emphasis on evaluation of therapeutic effectiveness in the treatment of insomnia. In younger situational insomniacs, whose sleep problem consists solely of longer than usual sleep latencies, L-tryptophan is effective in reducing sleep onset time on the first night of administration in doses ranging from 1 to 15 g. In more chronic, well-established sleep-onset insomnia or in more severe insomnias characterized by both sleep onset and sleep maintenance problems, repeated administration of low doses of L-tryptophan over time may be required for therapeutic improvement. In these patients, hypnotic effects appear late in the treatment period or, as shown in some studies, even after discontinuation of treatment. The improvement in sleep measures post-treatment has given rise to use of a treatment regimen known as "interval therapy", in which L-tryptophan treatment alternates with an L-tryptophan-free interval until improvement occurs. The absence of side effects and lack of development of tolerance in long-term use are important factors in the decision to embark upon a trial of L-tryptophan treatment. In addition, L-tryptophan administration is not associated with impairment of visuomotor, cognitive, or memory performance, nor does it elevate threshold for arousal from sleep.

Adolescent↗
PubMed1979

Behavioral treatment of presleep tension and intrusive cognitions in patients with severe predormital insomnia.

Behavioral approaches to the treatment of predormital insomnia have assumed that hyperarousal is the underlying cause; thus presleep tension has been the most common target treated. A second indicator, presleep intrusive cognitions, has only recently been examined as a target for treatment. In the present study, 20 subjects were randomly assigned to three groups which focused on the treatment of either (1) presleep tension alone, (2) presleep tension and intrusive cognitions, of (3) perception of sleep. Four subjects acted as controls. The findings indicated that reductions in both presleep tension and intrusive cognitions were followed by a significantly greater reduction in latency to sleep onset and daytime impairment than reductions in presleep tension alone. The results obtained from modifying the individual's perception of sleep were not significantly different from those obtained from reductions in presleep tension alone. A 6 weeks follow-up revealed no change in the relative status of the three treatment groups.

Adult↗
PubMed1987

Treatment of severe chronic insomnia with L-tryptophan: results of a double-blind cross-over study.

Thirty-nine subjects with chronic insomnia were treated with L-tryptophan (L-TRP) in a double-blind, cross-over study. Instead of a placebo, a very low dose of 0.04 g L-TRP was used. The subjects suffered from a sleeping disorder classified as "psychophysiological, persistent". In the subgroup taking the full L-TRP (2 g) dose first, there was a significant difference between the treatment period with the full L-TRP dose and the ineffective dose (placebo). If the placebo was given first, however, there was no significant difference between the two treatment periods. It is suggested that psychological factors are responsible for the diverging results in the two subgroups of patients. On the basis of subjective ratings, it appears that L-TRP is effective in promoting sleep in cases of chronic insomnia.

Adult↗
PubMed1987

Effects of delta-sleep-inducing peptide on 24-hour sleep-wake behaviour in severe chronic insomnia.

Impaired daytime functions are a significant part of chronic insomnia besides sleep disturbance. Therefore, the effects of intermediate-term delta-sleep-inducing peptide (DSIP) administration on sleep and daytime performance were investigated in 14 middle-aged chronic insomniacs. DSIP was administered under placebo-controlled, double-blind conditions for 7 successive nights. Polysomnograms were obtained for placebo baseline, beginning and end of DSIP treatment, and one placebo posttreatment night; daytime psychological state and mental performance were extensively tested before and after 6 DSIP injections. The treatment substantially improved night sleep with the first and additionally with repeated doses. These effects were maintained for the first posttreatment (placebo) night. Efficiency of night sleep and daytime rest reached the levels of normal controls. Alertness and performance at daytime increased significantly. The study demonstrates the efficacy of DSIP for the treatment of impaired sleep and daytime functions as well.

Adult↗
PubMed2000

Subjective measurement of insomnia and quality of life in depressed inpatients.

Insomnia and major depressive episodes (MDE) have each been associated with quality of life (QOL) deficits. In this study we examined insomnia as an independent predictor of QOL deficits during MDE, and used a secondary analysis of cross-sectional data. The study was based at the inpatient psychiatric ward and included 88 adults (mean age 53; 78% women). We assessed insomnia severity with the 21-item Hamilton Rating Scale for Depression (HRSD) and the Beck Depression Inventory (BDI). Measurements of QOL in the week prior to admission included activities of daily living (ADLs), instrumental ADLs (IADLs), daily living and role functioning, and relation to self and colleagues (the last two both subscales of the Basis 32). Linear regression models used the insomnia items as independent variables and the QOL measures as the dependent variables, after adjusting for age and nonsleep related depression severity. The results showed that 93% of patients endorsed insomnia on the observer-rated HRSD, and 97% endorsed sleep disturbance in the self-rated BDI. However, the insomnia items on the HRSD and BDI showed poor concurrent validity. Increasing severity of insomnia on the HDRS was associated with better QOL, while increasing severity of insomnia on the BDI was associated with worse QOL. We conclude that the BDI and HRSD do not produce equivalent measures of insomnia severity in depressed inpatients, and each insomnia measure has a unique relationship with QOL.

Adult↗
PubMed2005

Sensitivity and specificity of measures of the insomnia experience: a comparative study of psychophysiologic insomnia, insomnia associated with mental disorder and good sleepers.

STUDY OBJECTIVES: To explore proposed explanatory mechanisms in psychophysiologic insomnia by investigating the sensitivity and specificity of commonly used insomnia research tools in discriminating psychophysiologic insomnia, insomnia associated with mental disorder, and good sleepers. DESIGN: Cross-sectional, between-group comparison of responses from subjects with psychophysiologic insomnia, those with insomnia associated with mental disorder, and good sleepers to psychometrically robust self-report instruments. SETTING: Attendees at adult community outpatient clinics. PARTICIPANTS: Fifty-four adults (36 women, 18 men; average age 40 years) across 3 groups (n = 18 per group). Participants with psychophysiologic insomnia met combined Inteernational Classification of Sleep Disorders, Revised and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria and had no history of mental disorder. Participants with insomnia associated with mental disorder satisfied the same criteria for sleep disturbance and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Structured Clinical Interview for DSM-IV axis-I Disorders) criteria for depressive disorder. The majority had comorbid anxiety disorder. Insomnia duration in the groups with psychophysiologic insomnia and insomnia associated with mental disorder was around 10 years. Good sleepers served as a control group and included self-reported good sleepers with no history of sleep problems or psychiatric disorder. INTERVENTION: N/A. MEASUREMENTS AND RESULTS: Analyses of variance, adjusted for multiple comparisons, indicated no between-group differences on a measure of sleep-related stimulus control, and self-reported somatic arousal was higher in subjects with insomnia associated with mental disorder than in good sleepers or those with psychophysiologic insomnia. Subjects with insomnia associated with mental disorder and psychophysiologic insomnia had poorer sleep hygiene and were characterized by heightened mental arousal. Logistic regression indicated that "effortful preoccupation with sleep" discriminated subjects with both psychophysiologic insomnia (100% sensitivity, 94% specificity) and insomnia associated with mental disorder (100%, 100%) from good sleepers and that only depressive symptomatology discriminated insomnia associated with mental disorder from psychophysiologic insomnia. CONCLUSION: Psychophysiologic insomnia and insomnia associated with mental disorder may be on a continuum of insomnia severity, rather than categorically distinct. Insomnia associated with mental disorder may respond to psychological intervention. Factors specifically discriminating insomniacs from good sleepers require further investigation.

Adult↗
PubMed2004

Intradermal acupuncture on shen-men and nei-kuan acupoints in patients with insomnia after stroke.

This is the first study that focuses on the effects of intradermal acupuncture on insomnia after stroke. We enrolled hospitalized stroke patients with insomnia and assigned them into a real intradermal acupuncture group (RA group) or a sham acupuncture group (SA group) by randomization. The RA group received intradermal acupuncture on shen-men (He-7) and nei-kuan (EH-6) for 2 days, and the SA group received sham acupuncture on the same points. The effectiveness was measured by the Morning Questionnaire (MQ), Insomnia Severity Index (ISI), and Athens Insomnia Scale (AIS). These scales were examined by an independent, blinded neurologist before, and 1 and 2 days after treatment, repeatedly. Thirty subjects (15 in the RA group and 15 in the SA group) were included in the final analysis. The RA group showed more improvement on insomnia than the SA group. Repeated measures analysis detected that there were significant between-subjects effects in the MQ, the ISI and the AIS. In conclusion, we suggest that intradermal acupuncture on shen-men and nei-kuan is a useful treatment for post stroke-onset insomnia.

Acupuncture↗
PubMedDate not supplied

[Analysis of prescription patterns of antipsychotic agents in psychiatry].

INTRODUCTION: We describe the different diseases in which conventional and second generation antipsychotic (APS) prescriptions are made. METHOD: Observational, retrospective, multicenter study based on the review of 300 clinical records of public and private sites, hospital and out-patient clinics, located in Salamanca, Vigo, Bilbao, Barcelona, Valencia, Oviedo and Malaga. RESULTS: The mean age of the population studied was 42 +/- 17 years; 56.6 % were men. Atypical drugs (67 %) were used basically versus classical ones (33 %). Classical APS are basically prescribed in bipolar disorder with/without psychotic symptoms (20.6 %), schizophrenia (18.3%) and delusional disorder (11.5 %). Atypical APS are fundamentally prescribed in schizophrenia (31.5 %), bipolar disorders with/without psychotic symptoms (12.5 %) and other psychotic disorders (8.9 %). When the psychotic disorders are considered by groups (schizophrenia, bipolar disorder with psychotic symptoms, delusional disorder and other psychotic disorders), classical APS are used in 47.4 % and atypical APS in 62.5%. APS were used ((outside the indication)) (off-label) in 32.8%, including resistant depressions, serious obsessive-compulsive disorder and borderline personality disorder, with similar percentages for both conventional and atypical ones. In dementia, atypical APS were used in 5.1 % versus 1.5 % of the conventional ones. The most frequent reasons for prescription of classical APS were control of psychotic symptoms (33.6 %), aggressiveness-agitation (31.3 %), severe insomnia (16 %), impulsivity (6.9 %) and severe anxiety (6.1 %). Atypical APS were preferably used in the control of psychotic symptoms (58.8%) and aggressiveness-agitation (25.5%). CONCLUSIONS: The use of APS basically occurs within their authorized indications (67.2 %). The off-label use (32.8 %) occurs both for the classical as well as atypical APS and occurs in serious diseases in which there are no alternative treatments.

Adult↗
PubMed1993

Prevalence and treatment of insomnia in general practice. A longitudinal study.

The aim of the study was to assess prevalence and treatment modalities of insomnia in general practice. To investigate the course of insomnia, a longitudinal study design was adopted. Two thousand five hundred and twelve patients (age 18-65 years) were investigated with a questionnaire in general practice (T1). Four months later (T2) and again 2 years later (T3) a questionnaire was sent to all patients who had complained about severe insomnia at the time of the first inquiry. To assess insomnia, operationalized diagnostic criteria were applied (DSM-III-R). Eighteen point seven percent suffered from severe, 12.2% suffered from moderate and 15% suffered from mild insomnia. In the course of 2 years insomnia appeared as a chronic health problem. A high comorbidity of severe insomnia was found with chronic somatic and psychiatric disorders, especially with depression. Of the severely insomniac patients, 23.9% used prescribed hypnotics habitually, mainly benzodiazepines. The use of prescribed hypnotics remained rather stable during the whole study period. More than half of the patients reported a daily use of the hypnotics for 1-5 years or longer, but only 22% of the severely insomniac patients reported at the time of the third inquiry a significant improvement of insomnia due to the administration of sleeping pills. Thus, the long-term administration of benzodiazepine hypnotics seems to be an inadequate treatment strategy in chronic insomnia. Whether the occurrence of rebound insomnia after benzodiazepine withdrawal may be one of the main factors for chronic hypnotic use requires discussion.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1984

Sleep disturbances in a case of brain-stem lesions; pharmacological study.

A pharmacological study was carried out of a case of severe insomnia following brain-stem lesions; several polygraphic controls were used. Initially total duration of sleep was brief (less than 4 h) with a high REM/NREM ratio and a short paradoxical sleep (PS) latency. In addition, periodic breathing and tremor were observed. Slow injection of delta-sleep-inducing peptide (DSIP) improved sleep both quantitatively and qualitatively, although PS latency remained short. These effects were reversible. The effects of 5-HTP + benzerazide, of L-DOPA + benzerazide (Modopar) and of clonazepam (Rivotril) were compared.

Brain Stem↗
PubMed1997

Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial.

OBJECTIVE: To compare the side effect profiles of methylphenidate (MPH) and dexamphetamine (DEX) in children with attention deficit hyperactivity disorder (ADHD), as well as to determine which symptoms are genuine adverse effects of stimulant medication, as opposed to aspects of the child's underlying behavioral phenotype. DESIGN: Double-blind, crossover study. SETTING: Pediatric teaching hospital ambulatory behavior clinic. SUBJECTS: A total of 125 children with ADHD with a mean age of 104.8 months. INTERVENTIONS: Subjects received DEX (0.15 mg/kg/dose) and MPH (0.3 mg/kg/dose) twice a day for 2 weeks each in a randomized order. OUTCOME MEASURES: The Barkley Side Effects Rating Scale (17 symptoms; 0 = absent, severity rated from 1 to 9) was completed by parents at baseline and at the completion of each trial fortnight. RESULTS: Subjects' parents reported a significantly greater mean number (8.19) and mean severity (4.08) of "side effects" before commencing the trial than during the MPH period (number 7.19; severity 3.24), but not the DEX period (number 7.64, severity 3.73). The mean severity (but not mean number) was greater on DEX than on MPH. DEX caused more severe insomnia and appetite suppression compared with the baseline rating. Appetite suppression was the only item rated more severe on MPH than at baseline. Six side effects were significantly more severe on DEX than MPH: insomnia, irritability, proneness to crying, anxiousness, sadness/unhappiness, and nightmares. None were more severe on MPH than DEX. Overall, both MPH and DEX were well tolerated by most subjects, with only four subjects discontinuing the trial period because of severe adverse effects (2 -1.6%- on each stimulant). CONCLUSIONS: Many symptoms commonly attributed to stimulant medication are actually preexisting characteristics of children with ADHD and improve with stimulant treatment. At the doses investigated, both DEX and MPH caused appetite suppression, and DEX caused insomnia. Negative emotional symptoms were more severe on DEX than MPH.

Adolescent↗