Melatonin prolonged release: in the treatment of insomnia in patients aged ≥55 years.
Study Goal
The researchers aimed to evaluate the safety, efficacy, and tolerability of prolonged-release melatonin (2 mg) in treating primary insomnia in older adults, focusing on sleep quality and circadian rhythm regulation.
Results Summary
Melatonin PR 2 mg significantly improved sleep quality, latency, morning alertness, and health-related quality of life compared to placebo, with no adverse effects on psychomotor functions or memory. It was well-tolerated, showing no dependence, tolerance, or withdrawal symptoms.
Population
Patients aged ≥55 years with primary insomnia.
Effective Dosage
2 mg, 1-2 hours before bedtime.
Duration
Up to 13 weeks (short-term) and 6 months (long-term).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin prolonged release (PR) 2 mg | no change | psychomotor functions, memory recall or driving skills during the night or the next morning | older adults | - | had no effect on | #1 |
melatonin prolonged release (PR) 2 mg | decrease | many of these tasks | older adults | - | was associated with significantly less impairment on | #2 |
melatonin prolonged release (PR) 2 mg 1-2 h before bedtime | increase | many sleep and daytime parameters, including sleep quality and latency, morning alertness and health-related quality of life | patients with primary insomnia aged ≥55 years | - | was associated with significant improvements relative to placebo in | #3 |
melatonin PR 2 mg | increase | tolerability | older patients | - | was very well tolerated | #4 |
Short- or longer-term treatment with melatonin PR 2 mg | no change | dependence, tolerance, rebound insomnia or withdrawal symptoms | - | - | was not associated with | #5 |
Melatonin prolonged release (PR) 2 mg is approved for the treatment of primary insomnia characterized by poor sleep quality in patients aged ≥55 years in the EU and elsewhere. Patients may receive treatment with melatonin PR for up to 13 weeks. Production of endogenous nocturnal melatonin, which helps regulate circadian rhythm, may be decreased in older adults. Administration of melatonin PR 2 mg 1-2 h before bedtime mimics the natural secretion pattern of melatonin, thereby leading to improvements in the circadian regulation of the sleep-wake cycle. In older adults, melatonin PR 2 mg had no effect on psychomotor functions, memory recall or driving skills during the night or the next morning relative to placebo, and was associated with significantly less impairment on many of these tasks relative to zolpidem 10 mg alone or in combination with melatonin PR 2 mg. In 3-week and 6-month, randomized, double-blind clinical trials in patients with primary insomnia aged ≥55 years, melatonin PR 2 mg 1-2 h before bedtime was associated with significant improvements relative to placebo in many sleep and daytime parameters, including sleep quality and latency, morning alertness and health-related quality of life. Melatonin PR 2 mg was very well tolerated in clinical trials in older patients, with a tolerability profile that was similar to that of placebo. Short- or longer-term treatment with melatonin PR 2 mg was not associated with dependence, tolerance, rebound insomnia or withdrawal symptoms.