- Lemborexant, an investigational oral orexin receptor antagonist, outperformed placebo and zolpidem for improving objective measures of insomnia in older adults.
Why this matters
- Current pharmacotherapeutic options have adverse effects and limited effectiveness in this population.
- Change in log-transformed sleep latency (SL) vs placebo (least-squares geometric mean treatment ratio):
- Lemborexant 5 mg: 0.77 (P<.001>
- Lemborexant 10 mg: 0.72 (P<.001>
- Lemborexant 5 mg: 7.1% (P<.001>
- Lemborexant 10 mg: 8.0% (P<.001>
- Lemborexant 5 mg: –24.0 minutes (P<.001>
- Lemborexant 10 mg: –25.4 minutes (P<.001>
- Lemborexant 5 mg: –6.7 minutes (P=.004).
- Lemborexant 10 mg: –8.0 minutes (P<.001>
- 4 patients in zolpidem group.
- 2 patients in lemborexant 5 mg group.
- Authors of invited commentary note that no specific values were reported for sleep diary SL and WASO despite claims of statistically significant improvement.
- The lack of this information, they say, precludes understanding "how the variables that represent the patients’ presenting concerns were affected.”
- North American, European phase 3 randomized controlled trial: 1006 adults ages ≥55 years with confirmed insomnia disorder.
- Randomization: placebo vs zolpidem extended release (6.25 mg) vs lemborexant (5 or 10 mg) for 1 month at bedtime.
- Main outcome: polysomnographic SL for lemborexant vs placebo.
- Funding: Eisai.
- Unknown long-term outcomes.
- Use of fixed-dose zolpidem.
- Differences between objective, subjective WASO.