Seltorexant, a novel selective orexin-2 receptor antagonist, helped adults with insomnia initiate and maintain sleep better than placebo—and for some measures, zolpidem—over a two-week clinical trial, according to a study issued today by JAMA Psychiatry.
“Insomnia disorder is the most common sleep disorder and is associated with increased risk of daytime sleepiness, accidents, depressive disorders, insulin resistance, and total health care expenditures, and decreased quality of life and work performance,” wrote Sofie Mesens, M.D. of Johnson & Johnson, and colleagues. However, the most prescribed medications for insomnia, benzodiazepine and sedative hypnotics such as zolpidem, can cause daytime drowsiness, dependence, tolerance, and, particularly in older people, increased risk of falls and cognitive impairment.
In this drugmaker-sponsored study, Mesens and colleagues recruited 364 adults aged 18 to 85 from six countries who scored ≥15 on the Insomnia Severity Index and had no psychiatric comorbidities. The participants were given either seltorexant (5 mg, 10 mg, or 20 mg), immediate release zolpidem (5 or 10 mg, depending on the local country’s prescribing guidelines), or placebo for 14 days. The participants received a baseline sleep assessment via polysomnography (PSG) prior to receiving their medication, with follow-up PSGs on the first and 13th night of their treatment.
Compared with placebo, participants taking seltorexant 10 mg or 20 mg reduced their sleep initiation time on night one by 36% and 49%, respectively, and reduced their time awake in the six hours after initially falling sleep by 32% and 40%, respectively. Participants taking seltorexant 20 mg also showed greater improvement in sleep initiation on night one than zolpidem. The improvements with seltorexant 10 mg and 20 mg remained on night 13 but diminished among participants taking zolpidem. On night 13, seltorexant 10 mg and 20 mg were both superior to zolpidem for sleep initiation, and seltorexant 20mg was superior at reducing wake onset.
Seltorexant was generally well tolerated, but five participants stopped taking it due to adverse cardiovascular or cerebrovascular events. Overall, treatment-emergent adverse events were lower in the combined seltorexant group (34%) than in the zolpidem group (43%).
“Limitations of this study included that the participants composed a subpopulation with insomnia (those without psychiatric comorbidities) and that fewer than 3% of the participants in this study were women of childbearing potential, who make up a substantial proportion of patients with insomnia,” the researchers wrote.
For related information, see the Psychiatric News articles, “Sleep for Positive Mental and Physical Health” and “To Lower Suicide Risk, Treat Troubled Sleep.”
(Image: Getty Images/iStock/skynesher)
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