The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial.

Background: Clinical evidence on the use of cannabidiol (CBD) for sleep remains limited. Even fewer studies have tested the comparative effectiveness of cannabinoid formulations found within CBD products used for sleep or how they compare to other complementary therapies such as melatonin.

Methods: Participants (N = 1,793 adults experiencing symptoms of sleep disturbance) were randomly assigned to receive a 4-week supply of 1 of 6 products (all capsules) containing either 15 mg CBD or 5 mg melatonin, alone or in combination with minor cannabinoids.

Wrist actigraphic scoring for sleep laboratory patients: algorithm development.

Wrist actigraphy is employed increasingly in sleep research and clinical sleep medicine. Critical evaluation of the performance of new actigraphs and software is needed. Actigraphic sleep-wake estimation was compared with polysomnographic (PSG) scoring as the standard in a clinical sleep laboratory.

Genotyping sleep disorders patients.

Objective: The genetic susceptibility factors underlying sleep disorders might help us predict prognoses and responses to treatment. Several candidate polymorphisms for sleep disorders have been proposed, but there has as yet inadequate replication or validation that the candidates may be useful in the clinical setting.

Methods: To assess the validity of several candidate associations, we obtained saliva deoxyribonucleic acid (DNA) samples and clinical information from 360 consenting research participants who were undergoing clinical polysomnograms.

Self-reported long sleep in older adults is closely related to objective time in bed.

Although self-reported long sleep is associated with increased morbidity and mortality, little is known about the objective sleep patterns and daytime functioning of long sleepers, particularly those aged ≥50 years. Our primary aim was to compare the objective and subjective sleep patterns of a sample ( = 35) of middle- to older-aged adults who reported sleeping ≥8.5 h per night.

Meta-analyses of hypnotics and infections: eszopiclone, ramelteon, zaleplon, and zolpidem.

Study Objectives: Recent meta-analyses raising concern about risks of hypnotics suggest a need for more clarification of these risks.

Methods: Because of preliminary suggestions that eszopiclone causes infections, we studied US Food and Drug Administration files on the 4 most-recently approved hypnotics, combined with published studies, to compile the risk ratios of infections for groups randomly assigned to receive hypnotics versus those assigned to receive placebos in controlled trials. Parallel controlled clinical trials of eszopiclone, ramelteon, zaleplon, and zolpidem were included when data on subjects, duration of exposure, and adverse effects were available.

CPAP therapy of obstructive sleep apnea in type 2 diabetics improves glycemic control during sleep.

Background: Type 2 diabetes and obstructive sleep apnea (OSA) are frequently comorbid conditions. OSA is associated with increased insulin resistance, but studies of continuous positive airway pressure (CPAP) have shown inconsistent effects on glycemic control. However, endpoints such as hemoglobin A1c and insulin sensitivity might not reflect short-term changes in glycemic control during sleep.

Evaluation of immobility time for sleep latency in actigraphy.

Background: Actigraphy has become an important tool in sleep research, however, most actigraphic models have had little evaluation of their sleep scoring software. Some reports have described poor agreement of actigraph and polysomnogram (PSG) results. In this study, we examined the accuracy of the Actiwatch-L instrument with Actiware((R)) software version 5.

Possibility that certain hypnotics might cause cancer in skin.

Fifteen epidemiologic studies have associated hypnotic drugs with excess mortality, especially excess cancer deaths. Until recently, insufficient controlled trials were available to demonstrate whether hypnotics actually cause any cancers. The US Food and Drug Administration (FDA) Approval History and Documents were accessed for zaleplon, eszopiclone and ramelteon.

Circadian rhythm of CSF monoamines and hypocretin-1 in restless legs syndrome and Parkinson's disease.

The symptoms of restless legs syndrome (RLS) have a circadian pattern and central nervous system dopamine has been implicated in the pathogenesis of the condition. We sought to characterize circadian variation in dopamine and related compounds in human cerebro-spinal fluid (CSF). CSF was continuously withdrawn for 22 h from an implanted lumbar intradural catheter and sampled from three patients with RLS, three patients with Parkinson's disease (PD) and three healthy volunteers.

Greater incidence of depression with hypnotic use than with placebo.

Background: Although it has been claimed that insomnia causes an increased risk for depression, adequate controlled trials testing this hypothesis have not been available. This study contrasted the incidence of depression among subjects receiving hypnotics in randomized controlled trials versus those receiving placebo.

Methods: The incidence of depression among patients randomized to hypnotic drugs or placebo was compiled from prescribing information approved by the United States Food and Drug Administration (FDA) and from FDA New Drug Application documents.

Nasal cytology: a marker of clinically silent inflammation in patients with obstructive sleep apnea and a predictor of noncompliance with nasal CPAP therapy.

Study Objectives: Patients with obstructive sleep apnea treated with nasal continuous positive airway pressure (CPAP) often complain of nasal side effects. We studied patients before and after initiation of nasal CPAP to see how treatment affected nasal function and markers of nasal inflammation. We searched for pretreatment findings that might help to predict noncompliance.

Melatonin effects on luteinizing hormone in postmenopausal women: a pilot clinical trial NCT00288262.

Background: In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes.

Zolpidem for postanoxic spasticity.

A 28-year-old male sustained anoxic brain damage following aborted cardiac arrest, and subsequently developed severe muscular rigidity and spasticity involving all extremities. The spasticity was refractory to the standard regimens used for spastic hypertonia. Zolpidem dramatically inhibited muscular rigidity, spasticity, and dystonic posturing in a dose-dependent manner, resulting in a sustained improvement of his global performance over four years.

Differential gene expression in the T-helper lymphocytes of obstructive sleep apnea patients treated with nasal continuous positive airway pressure (nCPAP).

Obstructive sleep apnea (OSA) is a disease with significant morbidity, increased risk of accidents attributed to daytime somnolence, and has been associated with cardiovascular complications. The treatment of choice for OSA is nasal continuous positive airway pressure (nCPAP). Some OSA patients, however, are unable to benefit from this therapy as they find nCPAP intolerable due to the related nasal inflammation.