Behavioral Therapy May Be Superior to Zolpidem for Chronic Insomnia
Abstract
Researchers hope such information will aid the development of clinical guidelines for managing the care of people who have insomnia with and without comorbid psychiatric conditions.
The preliminary results of a randomized, controlled clinical trial comparing a behavioral insomnia therapy (BT) and zolpidem (a benzodiazepine receptor agonist) for the treatment of insomnia found that participants receiving BT had slightly higher response and remission rates six weeks after starting treatment than did those taking zolpidem.
The results were reported in separate lectures at the joint annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society in Denver in June by the study’s principal investigators: Jack Edinger, Ph.D., a professor of medicine and a behavioral sleep medicine specialist at National Jewish Health in Denver, and Charles Morin, Ph.D., a professor of psychology and director of the sleep research center at Laval University in Quebec.
The results, based on data from the first 70 enrollees in the study, showed that about half of those given BT responded, and one-third remitted. For participants who did not remit with BT, the addition of zolpidem or cognitive therapy (CT) as a second treatment yielded equivalent cumulative response and remission rates by the three-month follow-up.
For those who started with zolpidem but did not remit, use of BT or trazodone next brought improvements. Cumulative three-month remission and response rates were lower in this group, however, than in participants who received BT first.
According to Edinger, these preliminary findings suggest BT may be superior to zolpidem as a first-stage therapy for chronic insomnia and that sequenced therapies may augment outcomes achieved with initial treatments alone.
For the estimated 10 percent of American adults who meet DSM-5 diagnostic criteria for chronic insomnia, such information could prove important, Morin said.
Tracking Natural Progression of Insomnia
Who experiences insomnia? How common is it? How long does it last? How often does it resolve spontaneously?
Charles Morin, Ph.D., of Laval University in Quebec and colleagues conducted a series of longitudinal studies to address these questions.
They followed a population-based sample of 2,184 people with no history of insomnia for five years, finding that about 2 percent of the group reported each year they had experienced insomnia since the last assessment.
In another five-year study, Morin’s group assessed the persistence of insomnia in a population-based sample of people who reported insomnia symptoms at baseline. The researchers followed 1,020 adults who presented with subsyndromal insomnia—that is, who had some symptoms of insomnia, although they did not meet DSM-5 criteria for insomnia disorder—and 600 who met criteria for insomnia disorder when they entered the study. Nearly 63 percent of those with an insomnia disorder still had it five years later. Among those with subsyndromal insomnia, 53 percent remained subsyndromal, and 14 percent transitioned to an insomnia disorder. About 34 percent, however, improved to good sleeper status.
Morin and colleagues are mining data from their five-year studies to assess the impact of factors thought to predispose people to insomnia, including age, gender, hyperarousal, vulnerability to experience situational insomnia when under stress, personality traits, and family history.
They also are looking at factors that may precipitate insomnia, such as stressful life events and physical and psychological problems. Additionally, they are exploring factors that may modify insomnia’s course, including treatment, access to health care, and more.
Since insomnia often persists for years, Morin told Psychiatric News that it is appropriate for clinicians to begin treating symptoms of insomnia as soon as they emerge. “Ideally,” he said, “we’d intervene when people report subsyndromal insomnia.”
About 4 percent of people with chronic insomnia take medication to benefit sleep, he noted. Many others do not seek treatment or casually try tactics that do not improve their sleep. “No single treatment works for or is acceptable to everyone with insomnia,” he added. “Even when given a prescription for a hypnotic medication, some people do not fill it.”
A direct-to-consumer sleep education campaign could help teach the general public how to manage disturbed sleep before it becomes severe, he suggested. “Public health campaigns now promote nutrition and exercise,” he noted. “Good sleep is equally critical for optimum health.”
Study Protocol Described
Few studies have directly compared behavioral/psychological therapies with pharmacological therapies for chronic insomnia, the researchers noted. Fewer still have evaluated both modalities when given sequentially to patients who do not respond to their initial treatment. Edinger and Morin’s study, funded by the National Institute of Mental Health, seeks to fill those gaps.
“We hope to determine which treatment or treatments commonly used in primary care settings work best as a first option for chronic insomnia, and, if those don’t bring about a remission, what to do next,” Edinger told Psychiatric News.
The researchers have enrolled 224 participants with chronic insomnia at the two study sites, National Jewish Health and Laval University. About 60 percent of participants have insomnia comorbid with a psychiatric disorder.
After receiving an initial clinical evaluation and an overnight sleep assessment, the participants were randomly assigned to receive either BT or zolpidem for the first stage of the trial. The BT arm involves attending four informational sessions explaining and encouraging adoption of habits to promote good sleep, such as maintaining a regular bedtime and wake time and not using computers, cell phones, video players, or other electronic devices in the bedroom.
Initial outcomes were assessed at six weeks. Participants who met criteria for remission, as indicated by scores in the normal range on the Insomnia Severity Index (ISI)—a standard self-reported measure of insomnia symptom status—are continuing on the same therapy for the next 12 months.
Those not achieving remission at six weeks were offered re-randomization to a second, six-week treatment. Participants who received BT in the first stage without remitting are receiving zolpidem or CT in the second stage. CT, provided in four sessions, aims to help participants gain insight into factors that enhance their sleep and conquer beliefs and practices that hinder sleep. Those who received zolpidem first without remitting are receiving BT or trazodone in the second stage of the trial.
Participants are being reevaluated at three months and again at six, nine, and 12 months from the start of treatment.
The ISI score will serve as the primary outcome for comparing treatments. Researchers also will assess sleep diary and overnight sleep laboratory studies, reports on sleep and daytime function from the study participants and a blinded rater, adverse events, dropout rates, and treatment acceptability. ■
