The INSEMA Trial: Context Not Found
I was unable to locate any information about an "INSEMA trial" in the provided evidence base. The evidence contains comprehensive guidelines and research on insomnia treatment, but no specific trial by this name is referenced.
If You're Asking About General Insomnia Treatment
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the mandatory first-line treatment for all adults with chronic insomnia, to be initiated before any pharmacological intervention. 1, 2
Treatment Algorithm for Chronic Insomnia
Step 1: Initiate CBT-I First
- CBT-I demonstrates sustained benefits lasting up to 2 years and addresses underlying mechanisms rather than just suppressing symptoms 1
- Key components include sleep restriction therapy, stimulus control, cognitive restructuring, and sleep hygiene education (though the latter is insufficient as monotherapy) 1, 2
- Can be delivered through multiple effective formats: individual therapy, group sessions, telephone-based programs, web-based modules, or self-help books 1
Step 2: Add Pharmacotherapy Only If Needed
- Consider medications only when patients cannot participate in CBT-I, still have symptoms despite CBT-I, or as temporary adjunct 2
- First-line medications include short-intermediate acting benzodiazepine receptor agonists (BzRAs) or ramelteon 1, 3
For sleep onset insomnia:
For sleep maintenance insomnia:
Critical Medications to Avoid
The American Academy of Sleep Medicine explicitly recommends against:
- Over-the-counter antihistamines (diphenhydramine) due to lack of efficacy, anticholinergic effects, and delirium risk 1, 3
- Antipsychotics as first-line treatment due to metabolic side effects 1, 3
- Long-acting benzodiazepines due to increased risks without clear benefit 1
- Herbal supplements and melatonin due to insufficient evidence 1, 3
- Trazodone for insomnia (explicitly not recommended despite common use) 3, 2
Special Considerations for Elderly Patients
- Use lower doses: zolpidem maximum 5 mg, eszopiclone 1-2 mg 1, 3
- Avoid benzodiazepines due to increased fall risk and cognitive impairment 1
- Consider ramelteon 8 mg or low-dose doxepin 3 mg as safest choices 3
Common Pitfalls to Avoid
- Starting with medications before attempting CBT-I 1, 2
- Using sleep hygiene education alone as treatment 1, 2
- Prescribing over-the-counter antihistamines or herbal supplements 1, 3
- Continuing pharmacotherapy long-term without reassessment 1, 3
- Combining multiple sedative medications, which significantly increases risks 1, 3
If You're Referring to a Different Trial
Please provide additional context or clarify the trial name, as it may be referenced differently in the medical literature. The evidence base provided focuses on established guidelines from the American Academy of Sleep Medicine, American College of Physicians, and VA/DoD rather than specific trial names.