Somerlin for Sleep: No Evidence of Efficacy
I cannot recommend Somerlin for treating sleep disorders because there is no evidence in the medical literature supporting its use for insomnia or any sleep condition. None of the major clinical practice guidelines from the American College of Physicians, the VA/DoD, or the American Academy of Sleep Medicine mention Somerlin as a treatment option for sleep disorders 1.
What You Should Use Instead
First-Line Treatment: Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I should be the initial treatment for chronic insomnia disorder before considering any medication 1. This is a strong recommendation based on moderate-quality evidence from the American College of Physicians 1.
- CBT-I produces superior long-term outcomes compared to medications, with improvements sustained well beyond the treatment period 2
- CBT-I has no risk of tolerance, dependence, or serious adverse effects that are associated with sleep medications 1
- CBT-I can be delivered in primary care settings through individual therapy, group sessions, or even internet-based platforms 1
The core components include:
- Sleep restriction therapy (limiting time in bed to actual sleep time) 1
- Stimulus control (using bed only for sleep, maintaining consistent sleep-wake times) 1
- Cognitive restructuring (addressing maladaptive thoughts about sleep) 1
- Sleep hygiene education 1
- Relaxation techniques 1
Second-Line: Pharmacotherapy (Only After CBT-I Fails)
Medications should only be added through shared decision-making if CBT-I alone is unsuccessful 1. This is a weak recommendation based on low-quality evidence 1.
For General Adult Population:
- Low-dose doxepin (3-6 mg) is suggested for short-term use, with moderate-quality evidence showing improved sleep outcomes 1
- Nonbenzodiazepine receptor agonists (zolpidem, eszopiclone) may be considered, with low-to-moderate quality evidence 1
- Suvorexant showed moderate-quality evidence for improving treatment response and sleep outcomes 1
For Elderly Patients:
- Low-dose doxepin (3-6 mg) is the preferred medication for older adults, with the most favorable safety profile 3
- Avoid benzodiazepines due to risks of falls, cognitive impairment, dependency, and respiratory depression 1, 3
- Avoid diphenhydramine and other antihistamines due to anticholinergic effects and tolerance development 1, 3
- Avoid trazodone due to limited efficacy evidence despite widespread use 1
Critical Safety Warnings
All sleep medications are FDA-approved only for short-term use (4-5 weeks) and should not be continued for extended periods 1. The evidence is insufficient to evaluate long-term safety 1.
Observational studies have linked hypnotic drugs to serious adverse effects including:
- Dementia 1
- Serious injuries and fractures 1
- Daytime impairment and "sleep driving" 1
- Behavioral abnormalities and worsening depression 1
Common Pitfalls to Avoid
- Do not use melatonin - insufficient evidence for chronic insomnia disorder in both general and older adult populations 1
- Do not use ramelteon - low-quality evidence showed no statistically significant difference from placebo 1
- Do not use sleep hygiene education alone - it is ineffective as a standalone treatment and should only be part of comprehensive CBT-I 1
- Do not prescribe benzodiazepines - weak recommendation against their use due to safety concerns 1
Bottom Line
Since Somerlin has no established role in sleep medicine, start with CBT-I as first-line therapy 1. Only consider adding short-term pharmacotherapy with low-dose doxepin or nonbenzodiazepine receptor agonists if CBT-I fails, and only after discussing the significant risks with your patient 1.