Evaluation and management of insomnia in the clinical practice in Italy: a 2023 update from the Insomnia Expert Consensus Group.
Study Goal
The researchers aimed to evaluate the role of melatonin in treating insomnia, focusing on its efficacy, safety, and appropriate usage in clinical practice.
Results Summary
The study found that melatonin 2 mg prolonged release is effective for adults ≥55 years old, with a recommended usage duration of up to 13 weeks. It was positioned as a viable option among other treatments like cognitive behavioral therapy and other pharmacological agents.
Population
Adults aged 55 years and older with insomnia.
Effective Dosage
2 mg prolonged release.
Duration
Up to 13 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Cognitive behavioral therapy for insomnia | neutral | insomnia treatment | - | - | should be the first option | #1 |
Z-drug or a short-acting benzodiazepine | neutral | insomnia treatment | subjects < 65 years old | ≤ 4 weeks | use should be in the short term | #2 |
eszopiclone | neutral | insomnia treatment | the elderly | up to 6 months | may present a different profile and may be used | #3 |
melatonin 2 mg prolonged release | neutral | insomnia treatment | adults ≥ 55 years | up to 13 weeks | should be used | #4 |
daridorexant | neutral | insomnia treatment | adults and elderly | at least 3 months and up to 1 year | has been shown to be effective | #5 |
BACKGROUND: Insomnia is the most reported sleep disorder in industrialized countries, affecting, in the chronic form, around 10% of the European population. In Italy, such a percentage seems to be even higher. Although insomnia can be an independent disorder, it is frequently described as comorbid condition and may precipitate, exacerbate, or prolong a broad range of physical and mental disorders. Evaluating and targeting insomnia in the Italian clinical practice should be a priority. METHODS: The present expert opinions and recommendations represent an update from 2020 and insights from Insomnia Expert Consensus Group, based on systematic reviews according to PRISMA on available options in Italy from January 2020 to March 2023. RESULTS: We evaluated 28 papers among international guidelines, expert opinions, systematic reviews, and meta-analysis produced during the last 26 months. CONCLUSIONS: Our findings suggest that symptoms of insomnia must be assessed in the Italian clinical practice by evaluating nocturnal and daytime symptoms, comorbid conditions, and lifestyle. Cognitive behavioral therapy for insomnia should be the first option according to availability. The choice of the drug should be based on different factors including type of insomnia, age, comorbidities, and potential side effects. If the choice would be a Z-drug or a short-acting benzodiazepine (in subjects < 65 years old), the use should be in the short term (≤ 4 weeks). Indeed, eszopiclone, as a new option in Italy, may present a different profile and may be used for up to 6 months, also in the elderly. If the choice is melatonin, it should be used melatonin 2 mg prolonged release in adults ≥ 55 years for up to 13 weeks. A new dual orexin antagonist, daridorexant, is available in Italy; it has been shown to be effective in adults and elderly and it can be used for at least 3 months and up to 1 year.