Insomnia in older adults
Disorder of sleep initiation, maintenance, or early awakening in patients 55 and older with impaired daytime function. Standard therapy is cognitive-behavioural therapy for insomnia (CBT-I). Prolonged-release melatonin is registered for this age group as a second-line agent.
ICD-10 G47.03 drugs
Also known as: Chronic insomnia in patients over 55
Drugs used for this condition
- BMelatoninSecond line · Hypnotics. Melatonin receptor agonistsProlonged-release melatonin (Circadin 2 mg) is EMA-approved for short-term (up to 13 weeks) treatment of chronic insomnia in patients 55 and older. The effect is modest – sleep latency reduction by 9 minutes and improved subjective sleep quality. Used when CBT-I and standard hypnotics are contraindicated. Foundational therapy is CBT-I and sleep hygiene.
- BMirtazapineSecond line · Other antidepressants (NaSSA)Off-label mirtazapine 7.5–15 mg at bedtime for insomnia in patients with comorbid depression and anxiety is justifiable per AASM 2017. In non-depressed patients, no advantage over dedicated hypnotics. Sedation is maximal at low doses – escalation to 30–45 mg paradoxically reduces sedation (noradrenergic activation).
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit