Prescription, OTC drugs compared for insomnia
A systematic review and meta-analysis found that eszopiclone and lemborexant were effective, but eszopiclone might cause substantial adverse events and safety data on lemborexant were inconclusive.
Eszopiclone and lemborexant work for insomnia despite adverse events, while prescription drugs such as benzodiazepines, daridorexant, suvorexant, and trazodone can be effective but are associated with poor tolerability, according to a systematic review and meta-analysis.
Researchers compared the effectiveness of pharmacological treatments for acute and long-term treatment of adults with insomnia through a systemic review and meta-analysis of randomized controlled trials of pharmacological treatments as monotherapy. Primary outcomes were efficacy (quality of sleep measured by any self-rated scale), treatment discontinuation for any reason, including cessation due to side-effects, and safety (number of patients with at least one adverse event) both for acute and long-term treatment. Results were published July 16 by The Lancet.
One hundred seventy trials (36 interventions and 47,950 participants) were included in the systematic review, and 154 double-blind, randomized controlled trials (30 interventions and 44,089 participants) were included in the network meta-analysis. As acute treatment, benzodiazepines, doxylamine, eszopiclone, lemborexant, seltorexant, zolpidem, and zopiclone had more efficacy than placebo (estimates of certainty, high to moderate). Benzodiazepines, eszopiclone, zolpidem, and zopiclone had more efficacy than melatonin, ramelteon, and zaleplon (estimates of certainty, moderate to very low).
Intermediate-acting benzodiazepines, long-acting benzodiazepines, and eszopiclone led to fewer discontinuations from any cause than ramelteon (odds ratios [ORs], 0.72 [95% CI, 0.52 to 0.99], 0.70 [95% CI, 0.51 to 0.95], and 0.71 [95% CI, 0.52 to 0.98], respectively). Zopiclone and zolpidem had more discontinuations due to adverse events than placebo (ORs, 2.00 [95% CI, 1.28 to 3.13] and 1.79 [95% CI, 1.25 to 2.50), and zopiclone had more discontinuations than eszopiclone (OR, 1.82 [95% CI, 1.01 to 3.33]), daridorexant (OR, 3.45 [95% CI, 1.41 to 8.33]), and suvorexant (OR, 3.13 [95% CI, 1.47 to 6.67]). Benzodiazepines, eszopiclone, zolpidem, and zopiclone had more side effects than placebo, doxepin, seltorexant, and zaleplon.
For long-term treatment, eszopiclone and lemborexant had more efficacy than placebo, although the certainty was very low, and eszopiclone had better efficacy than ramelteon and zolpidem (both very low certainty).
The study authors concluded that overall, eszopiclone and lemborexant had a favorable profile, but eszopiclone might cause substantial adverse events. Safety data on lemborexant were inconclusive. Doxepin, seltorexant, and zaleplon were well tolerated, but data on efficacy and other important outcomes did not allow for firm conclusions, they said.
“Many licensed drugs (including benzodiazepines, daridorexant, suvorexant, and trazodone) can be effective in the acute treatment of insomnia but are associated with poor tolerability, or information about long-term effects is not available. Melatonin, ramelteon, and non-licensed drugs did not show overall material benefits,” the authors wrote.