New Insomnia Drug Appears Safe and Effective

A new, experimental insomnia drug appears to be safe and effective, according to a panel of FDA experts.

The drug, suvorexant, would be the first in a new class of insomnia drugs, called orexin receptor antagonists, that work by blocking brain chemicals that keep persons awake.

The drug’s manufacturer, Merck & Co, proposed that older patients start by taking 15 mg of the drug and, if necessary, increase that to 30 mg. The company recommended that younger adults start with 20 mg and, if needed, increase it to 40 mg.

The FDA panelists reiterated the opinion that there is little evidence to show that the higher dose is more effective than the lower dose and considerable evidence to show it is less safe. They pointed to an increase in the risk of suicidal thoughts and behaviors, an increased risk of impaired driving, and an increased risk of severe sleep disturbances.

Sleep disturbance is a major issue, particularly for older patients. The majority of older adults use some kind of treatment for sleep disturbance, according to the results of a new study.

More than half of older adults complain of insomnia. Multiple factors have been suspected to affect older adults’ ability to obtain sufficient sleep, including medical illness and polypharmacy, psychiatric disorders, psychosocial changes, and environmental changes associated with age, said Nicholas Badre, MD, of the University of California at San Diego, in his presentation at the American Association for Geriatric Psychiatry annual meeting.

“Use of sleep treatments is common and may have deleterious effects. Physicians may have an important role in reducing alcohol use for sleep, as well as in providing education in behavioral sleep treatments,” said Dr Badre.

In the study, Dr Badre and colleagues examined the prevalence and associations between self-reported sleep treatments, including over-the-counter (OTC) medications, prescription medications, alternative medications, behavioral techniques, and alcohol for sleep.

Data were used from the Successful Aging Evaluation study, a structured, multi-cohort, population-based study designed to assess successful aging in more than 1000 community-dwelling men and women in San Diego County, aged 50 to 99 years. There was an oversampling of persons in the 80s and 90s, he noted. Evaluation included a 25-minute telephone interview followed by a self-report survey of various domains of functioning.

Of the nearly 800 respondents, mean age 77 years, more than half used some form of treatment for sleep. About one-fourth of respondents used OTC treatments, about 1 in 6 used prescription medications, about 40% used behavioral techniques, about 10% used complementary or alternative treatments, and 10% used alcohol.

Female participants used more treatments for sleep, except alcohol, Dr Badre noted.

Lower reports of successful aging were noted in users of prescriptions, OTC medications, and alcohol for sleep but not with behavioral and alternative medicine management of sleep. Of significance, daily use of prescription medication was negatively associated with cognitive performance.

Clinical depression was associated with significantly increased odds of any use of treatment for sleep and the use of prescription treatment for sleep, Dr Badre said.