Insomnia patients with mental conditions often denied sleep treatment

Patients with insomnia who are diagnosed with accompanying mental health ailments often are not prescribed medication that will help them sleep – which could then make related anxiety or depression worse, new research suggests.

Scientists examining treatment patterns for insomniacs say that their findings suggest that many doctors appear to be reluctant to prescribe sleep aids, even those that pose no risk of dependence, if patients also have depression, anxiety or mood disorders. An exception is psychiatrists, who were found to be twice as likely as primary care physicians to prescribe medication for insomnia.

“Insomnia can cause you to have anxiety and depression, and depression and anxiety can cause you to have insomnia. It’s a chicken-and-egg type of story. But research has shown that if one of the conditions is left untreated it can exacerbate the other condition,” said senior study author Rajesh Balkrishnan, the Merrell Dow professor of pharmacy at Ohio State University.

“What this calls for is specific guidelines related to the treatment of insomnia that takes into consideration these different types of patients, because insomnia has become such a big public health problem.”

An estimated 20 percent of Americans have occasional sleep problems, with about one in 10 suffering from chronic insomnia.
Balkrishnan acknowledges concerns that physicians might have about prescribing certain medications that can cause dependence, especially to patients with mental health disorders. Older sleep aids, a class of drugs called benzodiazepines, are muscle relaxants with addictive properties and high potential for abuse. However, since the early 1990s, a new class of drugs for insomnia called non-benzodiazepines has been on the market. They are effective sleep aids that don’t carry the risk of addiction, Balkrishnan said, and for that reason, patients should have ready access to these medications.

“This research highlights the need to take into account that many patients who see their doctors with complaints of insomnia also have a psychiatric condition. But the presence of those mental conditions should not preclude them from being appropriately treated for their insomnia,” he said.

The study is published in the January issue of the Journal of Medical Economics.

Balkrishnan and colleagues collected data from the National Ambulatory Medical Care Survey, which tracks Americans’ annual outpatient medical visits. The researchers identified 5,487 physician visits by patients with insomnia between 1995 and 2004, which was calculated to represent about 161 million U.S. patients over that 10-year period.

According to the analysis, an estimated 6.5 million Americans who saw a doctor for insomnia also were diagnosed with a mental health disorder. Of the visits examined, 38 percent of patients with insomnia were diagnosed with at least one other condition, and at least four of every 10 of those accompanying conditions related to mental health. The most common additional condition was anxiety (15.6 percent), followed by episodic mood disorders (14.9 percent), high blood pressure (10.1 percent), depression (7 percent) and diabetes (3.5 percent).

The study showed that insomnia patients with mental health disorders were 36 percent less likely to receive medication for their sleeping problems than were patients without the mental health diagnosis. Those with anxiety were the least likely to receive a sleep aid, with a 45 percent decreased likelihood of receiving medication for insomnia compared to patients without anxiety.

Balkrishnan said that with generic forms of nonaddictive insomnia medication available by prescription, even patients taking antidepressants and anti-anxiety drugs can safely – and affordably – add a sleep aid to their regimen. The most common forms of antidepressants prescribed in the United States are a class of drugs called selective serotonin reuptake inhibitors (SSRIs).

“Physicians might perceive that drowsiness is induced by medications such as SSRIs so there might be a general fear about combining them with insomnia medications,” Balkrishnan said. “But I think those fears are somewhat unfounded because we found that psychiatrists don’t have any problems prescribing sleep medications in patients who have accompanying mental conditions; they know there is no danger of a drug-to-drug interaction.”

According to the analysis, patients visiting psychiatrists had two times higher odds of receiving medication for insomnia than patients visiting family practice or internal medicine physicians. The study showed that 33 percent of patients with insomnia saw family practice or internal medicine physicians, 30 percent visited psychiatrists and 9 percent went to neurologists.

The study identified other factors associated with insomnia medication prescribing patterns – for example, older and established patients were more likely to receive insomnia medications than were younger patients or those seeing the doctor for the first time. But Balkrishnan said a clear theme emerged from the analysis.

“There is a divide in who gets appropriate medication and who is not appropriately medicated,” he said. “It might not be happening willfully, but it points to a knowledge gap between different types of physicians and the need to develop widely accepted insomnia treatment guidelines. And the guidelines should be ratified by essentially all physicians treating the condition.”

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Sleep Problems May Up Suicide Risk

Adults who suffer chronic sleep problems may face an increased risk of suicidal behaviour, new research indicates.

In a study presented on April 1 at the World Psychiatric Association international congress “Treatments in Psychiatry,” scientists found that the more types of sleep disturbances people had, the more likely they were to have thoughts of killing themselves, engage in planning a suicidal act or make a suicide attempt.

“People with two or more sleep symptoms were 2.6 times more likely to report a suicide attempt than those without any insomnia complaints,” said the study’s leader, Dr. Marcin Wojnar, a research fellow at the Department of Psychiatry at the University of Michigan and Associate Professor of Psychiatry at the Department of Psychiatry at the Medical University of Warsaw in Poland.

The World Health Organization estimates that about 877,000 people worldwide die by suicide every year. The UN health agency says surveys indicate that for every death by suicide, anywhere from 10-40 suicide attempts are made.

“Identifying those at high risk of suicide is important for preventing it and these findings indicate that insomnia may be a modifiable risk factor for suicide in the general population,” Wojnar said. “This has implications for public health as the presence of sleep problems should alert doctors to assess such patients for a heightened risk of suicide even if they don’t have a psychiatric condition. Our findings also raise the possibility that addressing sleep problems could reduce the risk of suicidal behaviors.”

Scientists have consistently linked sleep disturbances to an increased risk of suicidal behaviour in people with psychiatric disorders and in adolescents, but it has been unclear whether the association also exists in the general adult population.

In the study, the broadest and most rigorously conducted of its kind, scientists examined the relationship over one year between three characteristics of insomnia (difficulty falling asleep, difficulty staying asleep and waking at least two hours earlier than desired) and three suicidal behaviours (suicidal thoughts, planning and attempts) in 5,692 Americans. About 35 percent of those studied reported experiencing at least one type of sleep disturbance in the preceding 12 months.

The most consistent link was seen for early morning awakening, which was related to all suicidal behaviours. People with this problem were twice as likely as those with no sleep problems to have had suicidal thoughts in the preceding 12 months, 2.1 times more likely to have planned suicide and 2.7 times more likely to have tried to kill themselves.

Difficulty falling asleep was a significant predictor of suicidal thoughts and planning. Compared with people who reported no sleep problems, those who had trouble initiating sleep had 1.9 times the risk of suicidal ideas and 2.2 times the risk of planning suicide.

People who had trouble sleeping through the night – waking up nearly every night and taking an hour or more to get back to sleep – were twice as likely to have thought of suicide in the last year and were three times more likely to have attempted it than those who had no sleep problems.

The results were adjusted for several factors known to influence suicide, including substance abuse, depression, anxiety disorder and other mood disorders, as well as chronic medical conditions such as stroke, heart disease, lung disease and cancer. They were also adjusted for the influence of sociodemographic factors such as age, gender, and marital and financial status.

How sleep disturbance might increase the risk of suicide is still poorly understood, Wojnar said. Scientists have proposed that insufficient sleep may affect cognitive function and lead to poorer judgement, less impulse control and increased hopelessness. A dysfunction involving serotonin – a brain chemical involved in mood regulation that plays an important role in sleep, psychiatric disorders and suicide – is also suspected.

Further research is needed to determine whether other sleep problems, such as sleep apnoea (interrupted breathing during sleep) and non-restorative sleep, where people feel unrefreshed after an adequate amount of sleep, are also associated with suicidal behavior, Wojnar added.

Intra-Cellular Initiates Clinical Trial For Sleep Maintenance Insomnia

Intra-Cellular Therapies has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug candidate ITI-722. ITI-722 acts predominantly as a selective 5-HT2A receptor antagonist and represents an important new approach to the treatment of SMI. Because of its novel separation of 5-HT2A and dopamine receptor modulatory activities, ITI believes, ITI-722 can be used not only to treat SMI but it may be highly appropriate for the treatment of sleep disorders that accompany neurodegenerative disorders, including Parkinson’s disease and other psychiatric disorders.

“The progression of ITI-722 into Phase 2 for SMI represents the advancement of this important new class of therapeutics,” stated Sharon Mates, Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies. “This drug candidate has therapeutic potential to treat SMI in the general population, and in other patient populations who have been underserved, particularly peri- and post-menopausal women, and in other disorders where insomnia is a problem, including osteoarthritis, depression, Parkinson’s disease and other neurologic and psychiatric disorders.”

The Phase 2 program is a multi-center, randomized, double-blind placebo- controlled study in patients with SMI. The primary endpoint is an assessment of objective slow wave sleep using polysomnography (PSG). Secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. Additionally, the study will make an assessment regarding next-day cognitive performance.

ITI-722 is a low-dose formulation of ITI-007, ITI’s first-in-class 5-HT2A antagonist/ dopamine receptor protein phosphorylation modulator (DPPM), presently in clinical trials for the treatment of schizophrenia.

About Sleep Maintenance Disorders

From nightmares to insomnia to sleep apnea, sleep disorders disrupt the sleep of millions of people all over the world. In particular, about 20% to 30% of the U.S. population complains of waking too early several times a week, a symptom of sleep maintenance insomnia (SMI) that is characterized by symptoms that include waking up frequently during the night with difficulty returning to sleep, waking up at early hours, and unrefreshing sleep. The majority of sleep complaints are related to SMI rather than sleep initiation or difficulty in falling asleep. However, there are no drugs currently approved in the U.S. that address only SMI. Furthermore, current sleep medications typically induce sedation and result in significant increases in daytime sleepiness that impairs quality of life in these patients. There is, therefore, a significant need for sleep medications that improve sleep quality without next-day hangover effects.

ABOUT ITI-722

ITI-722 is a highly potent 5HT2A antagonist for the treatment of sleep maintenance insomnia. Preclinical data has shown that ITI-722 is not sedating and should not exhibit next-day hangover effects that are commonly associated with other sleep medications. ITI-722 is expected to have a strong safety profile with no addiction liability. This compound is being evaluated for the treatment of sleep disorders in various patient populations with sleep maintenance problems and in other sleep disorders where staying asleep affects the quality of life, including nocturnal awakenings related to osteoarthritic pain, hot flashes in post-menopausal women and many psychiatric and neurodegenerative diseases.