Unisom Ingredients
Unisom SleepTabs contain doxylamine succinate 25 mg as the active ingredient, which is an antihistamine that should generally be avoided for chronic insomnia treatment, particularly in older adults. 1
Active Ingredient
- Doxylamine succinate 25 mg - This is a first-generation antihistamine with sedating properties 1
Inactive Ingredients
The inactive ingredients in Unisom SleepTabs include 1:
- Anhydrous dibasic calcium phosphate
- Dibasic calcium phosphate dihydrate
- FD&C blue no. 1 aluminum lake
- Magnesium stearate
- Microcrystalline cellulose
- Sodium starch glycolate
Important Clinical Context
Over-the-counter antihistamine sleep aids like Unisom (doxylamine) are not recommended for treating chronic insomnia due to lack of efficacy and safety data. 2 The American Academy of Sleep Medicine guidelines explicitly state that OTC antihistamine or antihistamine/analgesic type drugs are not recommended for chronic insomnia treatment. 2
Key Safety Concerns:
- Anticholinergic properties: Antihistamines carry risk of serious side effects from their anticholinergic effects 2
- Older adults: The 2015 Beers Criteria specifically recommends that individuals 65 years or older avoid diphenhydramine and doxylamine 3
- Limited evidence: Very few studies from the past decade use contemporary study designs to evaluate efficacy and safety 2
- Not for long-term use: Efficacy and safety data for OTC insomnia medications is limited to short-term studies 2
Clinical Pitfall:
Despite these recommendations, research shows that 59% of older adults taking OTC sleep medications use products containing diphenhydramine or doxylamine, and many are unaware of safety risks. 3 Healthcare providers should actively counsel patients about these risks and consider evidence-based alternatives such as cognitive behavioral therapy for insomnia (CBT-I) or FDA-approved prescription medications when appropriate.