Investigators Test Treatment Regimens for Psychiatric Disorders with Insomnia

Charles M. Morin, PhD

A combination of therapy with medication could be the most effective treatment plan to manage insomnia in individuals suffering from psychiatric disorders.

A team, led by Charles M. Morin, PhD, School of Psychology, Université Laval, evaluated the comparative efficacy of 4 treatment sequences involving psychological and medication therapies for insomnia, while examining the moderating effect of psychiatric disorders on insomnia outcomes.

While there is evidence of efficacious psychological and pharmacologic therapies for insomnia, there is not a lot of data on what first-line treatment should be and how best to proceed when initial treatment fails.

In the sequential multiple assignment randomized trial, the investigators randomized each patient to a first-stage therapy involving either behavioral therapy (BT; n = 104) or zolpidem (zolpidem; n = 107).

Patients who did not remit received a second treatment involving either medication (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy [CT]).

The investigators sought primary endpoints of the treatment response and remission rates, which was defined by the Insomnia Severity Index total score.

The study included 211 adult patients with a chronic insomnia disorder, including 74 patients with a comorbid anxiety or mood disorder. First-stage therapy with either behavioral therapy or zolpidem produced equivalent weighted percentages of responders (BT, 45.5%; zolpidem, 49.7%; OR, 1.18; 95% CI, 0.60-2.33) and remitters (BT, 38.03%; zolpidem, 30.3%; OR, 1.41; 95% CI, 0.75-2.65).

The best results came from second-stage therapies, which produced significant increases in responders for the 2 conditions, starting with BT (BT to zolpidem, 40.6% to 62.7%; OR, 2.46; 95% CI, 1.14-5.30; BT to CT, 50.1% to 68.2%; OR, 2.09; 95% CI, 1.01-4.35).

However, there were no significant changes following zolpidem treatment.

The investigators also found a significant increase in percentage of remitters in 2 of the 4 therapy sequences (BT to zolpidem, 38.1% to 55.9%; OR, 2.06; 95% CI, 1.04-4.11; zolpidem to trazodone, 31.4% to 49.4%; OR, 2.13; 95% CI, 0.91-5.00).

While the response and remission rates were lower among patients with psychiatric comorbidities, treatment sequences involving behavioral therapy followed by cognitive therapy or zolpidem followed by trazodone produced better outcomes for patients with comorbid insomnia.

The response and remission rates were well-sustained throughout a 12-month follow-up period.

“Behavioral therapy and zolpidem medication produced equivalent response and remission rates,” the authors wrote. “Adding a second treatment produced an added value for those whose insomnia failed to remit with initial therapies.”

Current treatment options for insomnia include various classes of medications, including benzodiazepine-receptor agonists and sedating antidepressants, as well as psychological therapies.

The majority of the medications prescribed for insomnia come with concerns about potential adverse effects such as daytime sedation, and risks of tolerance and dependence. There is also limited data documenting sustained benefits for prolonged use.

The investigators believe additional studies are warranted to validate the best treatment algorithms for insomnia disorder. They also suggest a more effective strategy involving a personalized approach matching patients with their preferred treatment while taking into account their insomnia phenotypes could replace the randomized approach to treatment options.

The study, “Effectiveness of Sequential Psychological and Medication Therapies for Insomnia Disorder,” was published online in JAMA Psychiatry.