BACKGROUND: Sleep problems are highly prevalent. Many chronic insomnia patients require sleep medication, despite non-pharmacological treatments. These patients are at risk of benzodiazepines misuse and abuse, given the rapid development of tolerance and dependence. Clinical experience suggests that low dose antidepressants might be alternatives to treat chronic insomnia, but evidence from RCTs is lacking.
OBJECTIVE: To assess the efficacy and safety of low dose amitriptyline and mirtazapine in chronic insomnia in general practice, when nonpharmacological treatment is insufficient.
STUDY DESIGN: double blind, randomized, placebo-controlled trial in general practice with 3 parallel groups (n=3*50).
POPULATION: adults with insomnia disorder (DSM-5) for whom non-pharmacological care is insufficient. Exclusion: contraindication for amitriptyline/mirtazapine including potential drug-drug interactions, current use of benzodiazepines or antidepressants, suicide risk, pregnancy/breastfeeding.
INTERVENTION: 4 months amitriptyline, mirtazapine or placebo, starting with 10 and 7.5 mg per day, respectively, and doubling of this dose after 3 weeks if needed, and single dosage during the final 2 weeks, followed by usual care in general practice. Follow up until 12 months. Reasons for nonadherence/discontinuation are monitored.
OUTCOME MEASURES: subjective insomnia severity and secondary outcomes include side effects, other sleep indices such as sleep pattern, daytime functioning, fatigue and mood symptoms (questionnaires) and medication/care consumption (questionnaire and medical records).
REVENUES: An effective and safe sleep medication suitable for general practice (which would counter new benzodiazepine dependence), or clarity that this off label use should be abandoned.
PATIENT PARTICIPATION: Both insomnia patients and physicians recognise the need for safe sleep medication and their experience is built in this proposal. We will establish an advisory group of insomnia patients.