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The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble with attentiveness, learning, and memory.

“To assist health care professionals and patients in finding the best dose to treat each individual patient’s sleeplessness, the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.

The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. Medications that treat insomnia can cause next-day drowsiness and impair driving and other activities that require alertness. People can be impaired even when they feel fully awake.

The FDA asked the drug manufacturer, Merck, Sharpe & Dohme Corp., to study next-day driving performance in people who had taken Belsomra. The testing showed impaired driving performance in both male and female participants when the 20 mg strength was taken. Patients using the 20 mg strength should be cautioned against next-day driving or activities requiring full mental alertness. Patients taking lower doses should also be made aware of the potential for next-day driving impairment, because there is individual variation in sensitivity to the drug.

The effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants. In the studies, patients taking the drug fell asleep faster and spent less time awake during the remainder of the night compared to people taking an inactive pill (placebo). Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications.

Like other sleep medicines, there is a risk from Belsomra of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Patients or their families should call the prescribing health care professional if this type of activity occurs.

Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance (Schedule-IV) because it can be abused or lead to dependence.

Belsomra is made by Merck, Sharpe & Dohme Corp. of Whitehouse Station, N.J.

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Researchers at NYU Langone Medical Center and elsewhere, using a mouse model, have recorded the activity of individual nerve cells in a small part of the brain that works as a “switchboard,” directing signals coming from the outside world or internal memories. Because human brain disorders such as schizophrenia, autism, and post-traumatic stress disorder typically show disturbances in that switchboard, the investigators say the work suggests new strategies in understanding and treating them.

Thalamic Reticular Nucleus ‘Switchboard’
This is an illustration of awake and asleep.
Credit: Michael Halassa, M.D., Ph.D.

In a study to be published in the journal Cell, a team led by Michael Halassa, MD, PhD, assistant professor of psychiatry, neuroscience and physiology, and a member of the NYU Neuroscience Institute, showed how neurons in the thalamic reticular nucleus (TRN) – the so-called switchboard – direct sensory signals such as vision from the outside world, and internal information such as memories, to their appropriate destinations.

“We have never been able to observe as precisely how this structure worked before,” says Dr. Halassa. “This study shows us how information can be routed in the brain, giving us tremendous insight into how it might be broken in psychiatric disorders.”

For the study, researchers used a multi-electrode technique to record the activity of individual neurons in the TRN, a thin layer of nerve cells that covers the thalamus, a structure in the forebrain that relays information to the cerebral cortex, the seat of higher-level functions such as learning and language. TRN cells are known to send inhibitory signals to the thalamus, determining which information is blocked.

The activity of TRN cells, the researchers found, depended on whether the mouse was asleep or awake and alert. TRN cells that controlled sensory input were far more active during sleep, particularly during the periods of sleep when brief bursts of fast-cycling brain waves, called spindles, occur. Sleep spindles, which are associated with blocking sensory input during sleep, are known to be diminished among people with autism and schizophrenia.

Dr. Halassa says the new findings suggest that faulty TRN cells may be disrupting the appropriate filtering of information in these conditions. His group is now exploring this filtering process in animal models of schizophrenia and autism.

In experiments with alert mice, Dr. Halassa’s group found that sensory TRN cells fired very little. This suggested that while these neurons block the flow of external information during sleep, they facilitate the flow of information when an animal is awake and alert.

By contrast, TRN cells that control the flow of internal signals behaved in an opposite fashion, firing very little in sleep. This lowered level of activity, Dr. Halassa suspects, may allow memories to form, which is known to occur during sleep. The thalamus has nerve connections to the hippocampus, which plays an important role in learning and memory.

In a second part of the study, Dr. Halassa’s group employed a technique called optogenetics, which uses light to turn nerve cells on and off, to test whether altering TRN nerve cell firing affected attention behavior in the mice.

In one experiment, mice learned to associate a visual stimulus with food. Well-rested mice took just a second or two to find food when a stimulus was presented, while sleep-deprived mice took much longer. By turning on TRN cells that specifically controlled the visual part of the thalamus, as would happen normally in sleep, the rested mice behaved like they were sleep deprived. On the other hand, when the researchers turned off these TRN cells, sleep-deprived mice quickly found the food.

“With a flick of a light switch, we seemed able to alter the mental status of the mice, changing the speed at which information can travel in the brain,” says Dr. Halassa. Mapping brain circuits and disrupting their pathways will hopefully lead to new treatment targets for a range of neuropsychiatric disorders, he adds.

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People with schizophrenia struggle to turn goals into actions because brain structures governing desire and emotion are less active and fail to pass goal-directed messages to cortical regions affecting human decision-making, new research reveals.

Published in Biological Psychiatry, the finding by a University of Sydney research team is the first to illustrate the inability to initiate goal-directed behaviour common in people with schizophrenia.

The finding may explain why people with schizophrenia have difficulty achieving real-world goals such as making friends, completing education and finding employment.

“The apparent lack of motivation in schizophrenic patients isn’t because they lack goals or don’t enjoy rewards and pleasure,” says the University of Sydney’s Dr Richard Morris, the study’s lead author. “They enjoy as many experiences as other people, including food, movies and scenes of natural beauty.

“What appears to block them are specific brain deficits that prevent them from converting their desires and goals into choices and behaviour.”

Using a control group research design, the researchers used a two-prong approach to reveal how and why schizophrenics fail to convert their preferences into congruent choices.

First, using a series of experiments involving choosing between different snack food rewards, experimenters revealed that:
◾ schizophrenic subjects had a liking for snack foods equivalent to healthy adults
◾ when researchers reduced the value of one of the snacks, both subjects and healthy adults subsequently preferred different snacks, as expected
◾ surprisingly, schizophrenic subjects had major difficulty choosing their preferred snack when provided with a choice between their preferred snack and the devalued snack.

Second, researchers used functional magnetic resonance imaging (fMRI) to measures brain activity while study subjects performed learning tasks involving snack foods. This technique relies on the fact that cerebral blood flow and neuronal activity are coupled.

When an area of the brain is in use, bloodflow to that region increases, thereby indicating neural activity. This neural activity can be presented graphically by colour-coding the strength of activation across the brain or in specific brain regions. The technique can localise neural activity to within millimetres.

Functional MRI results revealed the following:
◾ schizophrenic subjects had normal neural activity in the brain region responsible for decision-making (prefrontal cortex)
◾ among schizophrenic subjects, brain regions responsible, in part, for controlling actions and choice (the caudate) had far lower neural activity than in healthy subjects
◾ lower neural activity in the caudate regions was correlated with the difficulty that schizophrenic subjects’ had applying their food preferences to obtain future snack foods.

“Pathology in the caudate and associated brain regions may prevent schizophrenic subjects from properly evaluating their desires then transmitting that information to guide their behavior,” says Dr Morris.

“This means that desires and goals are intact in people with schizophrenia, however they have difficulty choosing the right course of action to achieve those goals.

“This failure to integrate desire with action means people with schizophrenia are stuck in limbo, wanting a normal life but unable to take the necessary steps to achieve it.”

Schizophrenia affects one per cent of people worldwide, including in Australia. However so-called “poor motivation” in schizophrenia is a major economic concern because it is not treated by current medicines, and often means patients fail to finish their education or hold a full-time job.

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Some working parents are carrying more psychological baggage than others – and the reason has nothing to do with demands on their time and energy.

The cause is their occupation.

According to University of Iowa researchers, parents who hold jobs viewed by society as aggressive, weak, or impersonal are likely to be more stressed out than parents whose occupations are seen in a light similar to parenting – good, strong, and caring.

“We know that one source of stress for parents is the time and energy bind,” says Mark Walker, a doctoral student in sociology at UI. “But what I wanted to examine was the extent to which discrepancy between the cultural meanings of a person’s occupational and parental identities could impact the psychological well-being of working parents.”

“What we found is, in fact, it does,” he adds.

Walker presented his study at the 109th Annual Meeting of the American Sociological Association.

“I think the research is important in that it gives a name to something that I think many working parents experience but couldn’t quite put a finger on,” says Walker. “I think identifying the issue as a social problem rather than an individual one, or even worse: an imaginary problem, could be helpful to working parents in and of itself.”

Walker’s premise for the study was the fact that for every role people play in their lives – be it parent, church member, or professor – there is an identity. And attached to that identity is a “cultural meaning,” which is how society views that identity.

“We use cultural information to define those identities,” he says. “How people treat us and react to us is based on that cultural information.”

For his study, Walker merged data on the cultural sentiments attached to parental and occupational identities with a traditional large-scale survey on work-family conflict and came up with a three-dimensional graph on which various occupations were plotted.

What Walker discovered is that the public is often skeptical about the abilities of parents whose occupations seemingly do not align with being a mother or a father.

“If a person is constantly met with skepticism, he or she can begin to feel stressed because that skepticism will take a toll over time,” he says. “Those parents are always swimming upstream trying to convince people they are, for example, a legitimate parent or a legitimate attorney.”

Among occupations that create more psychological baggage are: attorney, salesperson, laborer, receptionist, police officer, or politician. Those that align better, in terms of societal perception, with parenting include: teacher, physician, registered nurse, principal, and professor.

Study co-author Mary Noonan, an associate professor of sociology at UI, said the findings warrant a closer look by sociologists.

“I used to think the whole conflict was about time and energy and not so much this internal conflict about identity,” she says. “These are pretty exciting results.”

Walker says the study could help shape policy and workplace changes designed to reduce the psychological strain of juggling the roles of parent and worker.

“If employers are aware that working parents in a given occupation are more at risk of experiencing psychological strain, they could potentially provide more targeted mental health resources for those in ‘at risk’ occupations,” he says.

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More than 40 percent of Social Security Disability Insurance (SSDI) recipients take opioid pain relievers, while the prevalence of chronic opioid use is over 20 percent and rising, reports a study in the September issue of Medical Care. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The high proportion of SSDI recipients who are chronic opioid users – in many, at high and very high daily doses – “is worrisome in light of established and growing evidence that intense opioid use to treat non-malignant [non-cancer] pain may not be effective and may confer important risk,” write Dr Nancy Elizabeth Morden and colleagues of the Dartmouth Institute for Health Policy & Clinical Practice, Lebanon, N.H.

Rising Prevalence of Opioid Use by SSDI Recipients

The researchers analyzed trends in use of prescription opioids (morphine-related drugs) among disabled Medicare beneficiaries under age 65 between 2007 and 2011. Nearly all under-65 Medicare beneficiaries are SSDI recipients; patients who go on SSDI are eligible for Medicare after two years.

Consistent with reports of an “opioid epidemic” in the United States, the results showed high and rising prevalence of opioid use by SSDI recipients. The percentage of beneficiaries taking opioids increased from 2007 through 2010. In 2011, the most recent year with available data, prevalence dipped slightly to 43.7 percent.

The percentage of these beneficiaries with chronic opioid use rose steadily, from 21.4 percent in 2007 to 23.1 percent in 2011. Chronic opioid users received numerous opioid prescriptions – at least six and generally 13 per year – typically prescribed by multiple doctors. Women were at greater risk of becoming chronic opioid users than men.

Among chronic opioid users, the average “morphine equivalent dose” (MED) also dipped in 2011. Still, nearly 20 percent of chronic users were taking a dose of at least 100 milligrams MED, while ten percent were taking 200 milligrams. “Opioid use of this intensity has been associated with risk of overdose death in the general US population and more specifically in disabled workers,” Dr Morden and colleagues write.

With Wide Regional Variations in Opioid Prescribing

The researchers also found variations in opioid use across US health care regions. The regional prevalence of opioid use among SSDI recipients ranged from 33.0 to 58.6 percent; chronic use ranged from 14.0 to 36.6 percent. Drug dosage and specific opioids prescribed also varied by region.

The high prevalence and intensity of opioid use among SSDI recipients parallels the preponderance of musculoskeletal disorders, such as back pain – some type of musculoskeletal condition was present in 94 percent of chronic opioid users. The researchers also note the high rate of depression, 38 percent, among patients taking chronic opioids.

Dr Morden and colleagues voice concern about the trends in opioid use by SSDI recipients – particularly chronic use at potentially hazardous doses. “We are not suggesting that all chronic opioid use is more harmful than beneficial,” they write, “but rather that the common and increasing chronic use we observed seems inconsistent with the uncertainties surrounding such prescribing practice.”

The regional variation identified in the study “shows a lack of standardized approach and reveals regions with mean MED levels associated with overdose risk,” the researchers add. They urge further studies to assess the clinical outcomes of opioid use by under-65 disabled workers and factors associated with chronic opioid use. They also call for the development of policies and programs that balance safety with high-quality pain management for this complex group of patients.

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