The Controversial Ingredients That Led to Recalls
Sominex's history in the market is characterized by multiple formula changes and regulatory issues. A primary reason for a significant recall in the U.S. was the ingredient methapyrilene. In 1978, after a preliminary study suggested methapyrilene could cause tumors in animals, the FDA requested accelerated testing.
Based on these findings, Health and Human Services Secretary Joseph A. Califano Jr. called for these drugs to be removed from the market. A voluntary recall was announced in June 1979, resulting in Sominex and other products containing methapyrilene being pulled from shelves.
Other Problematic Formulations and Withdrawals
Prior to the 1979 recall, other Sominex formulations also faced challenges. A 1975 version containing scopolamine was deemed ineffective as a sleep aid at recommended doses by an FDA panel and potentially hazardous at higher amounts. This formulation was linked to side effects such as hallucinations. Additionally, in December 1975, the FDA recalled Sominex 2, which contained diphenhydramine, due to inadequate child-resistant packaging and missing warnings on the label.
Documented Ineffectiveness of Early Versions
Beyond safety, the effectiveness of Sominex was also questioned. Studies in the 1970s indicated that some early formulas were no more effective than a placebo for sleep. Dr. Anthony Kales, a sleep researcher, found Sominex unhelpful for patients with moderate to severe insomnia. FDA officials also criticized advertising for exaggerating the drug's effectiveness.
The Evolution and Continued Concerns with Successive Formulas
Following the 1979 recall, the Sominex formula in the U.S. was changed to use diphenhydramine, an ingredient also found in Benadryl and approved by the FDA as an occasional sleep aid. However, diphenhydramine is associated with side effects such as daytime drowsiness, dry mouth, blurred vision, constipation, and urinary retention. Older adults may experience more severe effects like confusion and an increased risk of falls. Organizations like the American Academy of Sleep Medicine (AASM) do not recommend OTC sleep aids, including those with diphenhydramine, for insomnia due to limited evidence for long-term use.
Sominex and Modern OTC Sleep Aids
The current OTC sleep aid market is regulated, offering various options, though expert caution persists. Understanding the historical context of Sominex is helpful in evaluating modern alternatives.
Comparison of Sominex Formulations and Alternatives
| Feature | Early Sominex (1970s) | Post-Recall Sominex (U.S.) | Modern Alternatives (e.g., Unisom) |
|---|---|---|---|
| Active Ingredient(s) | Methapyrilene, Scopolamine, Salicylamide | Diphenhydramine | Doxylamine or Diphenhydramine |
| Recall Reason | Potential carcinogen (methapyrilene), Ineffective, Dangerous side effects (scopolamine) | Not recalled as a drug class, but specific variants like Sominex 2 were recalled for packaging/labeling. | Follows current FDA monograph. |
| Efficacy Concerns | Found no more effective than a placebo. | Only for occasional, short-term sleeplessness. | Approved for occasional, short-term sleeplessness. |
| Primary Safety Concerns | Hallucinations, disorientation, cancer risk (animal studies). | Daytime drowsiness, confusion, risks for older adults. | Similar side effects and risks to diphenhydramine. |
| Current Status | Discontinued | Discontinued, though brand name may appear in other countries with different formulas (e.g., herbal). | Readily available under various brand names. |
The End of Sominex and Brand Evolution
Even after switching to diphenhydramine, the brand's prominence in the U.S. declined. In the UK, a version with promethazine was withdrawn by the manufacturer in 2018. A different company, Teva UK Limited, has since re-established the brand, offering herbal formulations in some regions.
The history of Sominex illustrates the evolution of drug regulations, the impact of safety data, and the importance of efficacy. Its varied past highlights the need to consult healthcare professionals about sleep issues rather than relying on historical OTC options. For chronic insomnia, lifestyle changes and other medical interventions are often more effective. Learn more about FDA drug safety alerts on the official FDA website.
Conclusion: Lessons from the Sominex Story
The history of Sominex serves as an important example in the realm of over-the-counter medications. Its discontinuation was a result of multiple factors, primarily the 1979 recall initiated after the ingredient methapyrilene was identified as a potential carcinogen. Other regulatory actions, such as the 1975 recall of Sominex 2 due to packaging and labeling issues, also played a role. Furthermore, early formulations were found to be no more effective than a placebo. While later versions used diphenhydramine, concerns regarding its side effects and suitability for long-term use remained. This trajectory demonstrates the dynamic nature of drug safety standards and the ongoing need for professional medical guidance when addressing sleep difficulties.
