From the Guidelines
Cognitive behavioral therapy for insomnia (CBT-I) should be considered the first-line treatment for adults with chronic insomnia disorder. This recommendation is based on the most recent and highest quality study, which found that CBT-I improved global outcomes, including increased remission and treatment response, and reduced insomnia severity index (ISI) and Pittsburgh Sleep Quality Index (PSQI) scores compared to controls 1.
Key Components of CBT-I
The following components are typically included in CBT-I:
- Sleep restriction therapy
- Stimulus control
- Cognitive therapy
- Relaxation strategies
- Sleep hygiene education
Benefits of CBT-I
The benefits of CBT-I include:
- Improved sleep outcomes, such as reduced sleep onset latency and wake after sleep onset, and improved sleep efficiency and sleep quality
- Increased remission and treatment response
- Reduced ISI and PSQI scores
- Durable benefits beyond the end of treatment
Pharmacological Therapy
If CBT-I is unsuccessful, pharmacological therapy may be considered, with a shared decision-making approach discussing the benefits, harms, and costs of short-term medication use 2. Options include:
- Eszopiclone (1-3mg)
- Zolpidem (5-10mg)
- Doxepin
- Trazodone (25-100mg)
Important Considerations
When selecting a treatment, clinicians should consider comorbid medical and psychiatric conditions, as well as the potential adverse effects of treatment-induced sleep deprivation. Patients should be reminded that psychological and behavioral insomnia therapies typically produce gradual improvements in insomnia symptoms, but the benefits are durable beyond the end of treatment 1.
From the FDA Drug Label
Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The treatment options for insomnia (sleep disorder) are:
- Ramelteon (PO): for the treatment of insomnia characterized by difficulty with sleep onset 3
- Zolpidem (PO): for the short-term treatment of insomnia characterized by difficulties with sleep initiation 4
From the Research
Treatment Options for Insomnia
The treatment of insomnia should involve a multi-disciplinary approach, focusing on implementing behavioral interventions, improving sleep hygiene, managing psychological stressors, hypnotic treatment, and pharmacological therapy 5.
- Non-pharmacological measures: Cognitive Behavioral Therapy for Insomnia (CBT-I) is a hallmark of chronic insomnia treatment, and other new therapies including meditation have been proven to be effective 6.
- Pharmacologic treatment: Sedative hypnotic agents, particularly those that are active through the benzodiazepine receptor-GABA complex, such as benzodiazepines, eszopiclone, zaleplon, and zolpidem, are commonly used to treat insomnia 5, 7, 8.
- Melatonin and melatonin-receptor agonist: Ramelteon has not had adequate study in psychiatric patients to define its use, but small studies suggest benefit 8.
- Adjunctive trazodone: Prescription of adjunctive trazodone is a common clinical practice to treat comorbid insomnia during antidepressant therapy, but published data are surprisingly limited 8.
- Atypical antipsychotic agents: Quetiapine, olanzapine, or others may be used to lessen agitation that disrupts sleep, although there has been insufficient research on their use in severe insomnia 8.
- Dual orexin receptor antagonists (DORAs): Daridorexant is a new treatment option for insomnia, and it does not require special switching or deprescribing protocols 9.
Switching or Deprescribing Hypnotic Medications
Clear guidance regarding safe and effective protocols for switching these medications currently lacks in Europe, but some recommendations have been formulated 9.
- Discontinuation of Hypnotic Benzodiazepines and Z-drugs: Should be gradual, with dose reductions of 10-25% each week.
- Cross-tapered program: Multi-component CBT-I, daridorexant, eszopiclone, and melatonin 2 mg PR can facilitate the gradual discontinuation of hypnotic benzodiazepines/Z-drugs.
- Sedative-hypnotic dosage reduction algorithms: Several algorithms are proposed for clinical use in real-world settings 9.