What is Insomnia Disorder?
Insomnia disorder is a common sleep disorder, affecting a significant portion of the adult population in the UK. Estimates suggest that between one in five and one in three adults experience insomnia. This widespread issue can significantly impact an individual’s quality of life. Insomnia disorder is typically diagnosed when a person experiences difficulties with sleep quality or quantity for at least three nights a week, over a period of three months or more. This can lead to daytime impairments such as fatigue, irritability, and difficulty concentrating.
Common Treatments for Insomnia Disorder
First-line treatments for insomnia include benzodiazepines or Z-drugs which, while can provide short-term relief. However, long-term use may be associated with potential adverse effects. Cognitive behavioural therapy (CBT) is also a recommended approach for many individuals.
In some cases, healthcare professionals may prescribe low doses of antidepressants, such as amitriptyline or mirtazapine, as alternative treatments. While observational data and some non-controlled studies have suggested these medications may assist with sleep maintenance, further research with placebo-controlled studies is needed to confirm these findings.
Study Examining Amitriptyline and Mirtazapine
A recent randomised, double-blind, placebo-controlled trial investigated the effectiveness of low-dose amitriptyline and mirtazapine in patients with insomnia. The study aimed to evaluate their efficacy over a 16-week treatment period and a 52-week follow-up.
Study Methodology
The study involved 80 participants diagnosed with insomnia disorder. Participants received daily doses of either mirtazapine (7.5 mg), amitriptyline (10 mg), or placebo over 16 weeks. Patient-reported outcomes were assessed at baseline, during treatment (weeks 6 and 12), and follow-up (weeks 50 and 52).
The primary outcome was the change in insomnia severity, measured using the Insomnia Severity Index. Secondary outcomes included self-reported sleep quality, daytime symptoms, functioning, treatment satisfaction, tolerability, and adherence.
Key Findings for Mirtazapine
- Short-term effects: Mirtazapine showed an improvement in insomnia severity at 6 weeks, but this effect was not sustained at 12 weeks or during the 52-week follow-up.
- Side effects: The mirtazapine group reported more side effects and treatment discontinuations compared to placebo, indicating potentially lower tolerability.
- Other measured outcomes showed smaller and less consistent improvements compared to placebo.
- A reduction in wake time after sleep onset (WASO) at week 6, and a reduction in anxiety, depression and fatigue at week 12 were noted.
Key Findings for Amitriptyline
- Short-term effects: Amitriptyline showed a reduction in insomnia severity at 6 weeks, but the effect was not considered clinically relevant.
- Tolerability: Amitriptyline was generally well-tolerated.
- No statistically significant or clinically relevant improvements were observed in sleep or daytime outcomes compared to placebo during or after treatment.
- No statistically significant or clinically relevant improvements were observed in secondary outcomes during treatment or follow-up.
What Does This Mean for Patients?
This study provides valuable insights into the use of mirtazapine and amitriptyline for insomnia. The results suggest that mirtazapine may offer short-term benefits for insomnia symptoms. However, the study did not support its long-term effectiveness.
Therefore, healthcare professionals may consider prescribing low-dose mirtazapine for short-term symptom relief in individuals with insomnia, with careful monitoring of potential side effects through follow-up consultations. Amitriptyline, while well-tolerated, did not demonstrate clinically relevant improvements in this study.
Insomnia and Curaleaf Clinic
Understanding the complexities of insomnia can be challenging, and finding the right treatment approach is essential for improved sleep and overall well-being. At Curaleaf Clinic, we recognise the impact that sleep disorders can have on daily life. We offer comprehensive assessments and personalised treatment plans, and discussions about suitable medication options. Our healthcare professionals are dedicated to providing evidence-based care, empowering patients to make informed decisions about their sleep health. We are committed to supporting individuals in their journey towards achieving restful and restorative sleep.
Important Note:
It is crucial to consult with a healthcare professional to determine the most appropriate treatment plan for insomnia disorder. Individual responses to medications can vary, and treatment decisions should be based on a comprehensive assessment of each patient’s needs.
Important Note:
It is crucial to consult with a healthcare professional to determine the most appropriate treatment plan for insomnia disorder. Individual responses to medications can vary, and treatment decisions should be based on a comprehensive assessment of each patient’s needs.
