Sominex

As early as the 1950s, Sominex was being promoted in television commercials. One ad spot featured the image of the sleeping pill tablet itself as a classic bouncing ball to follow the lyrics of their jingle, shown on the lower third of the screen.^[14] The commercial aired on a 1958 episode of the Arthur Murray Party.^[15]

In 1959, Sominex was noted as one of the major brands pushing patent medicines in television ads.^[16] Congressman John Blatnik had previously revealed that the manufacturer of Sominex, Pharmaceuticals, Inc., was selling lemon-flavored skim milk under the brand name of RDX, US¢7 product they sold for US$3.00 per bottle.^[17]

As early as 1960, Sominex was advertised in newspapers as having been hospital-tested.^[18]

In 1971, Sominex was a combination of scopolamine aminoxide hydrobromide, methapyrilene hydrochloride, and salicylamide,^[19] the last of which is noted as a pain killer,^[20] and comprised the largest part of the formula.^[21] This formula was still in use in 1975,^[22][23] 1977,^[24] and in 1982.^[25] A survey of elderly patients between 1978 and 1980 identified the formula as containing aminoxide-methapyrilene.^[26] It was produced by J.B. Williams Co., Inc., who also made Sominex 2.^[22]

The FDA requested that the National Cancer Institute speed up testing on over-the-counter drugs containing methapyrilene in 1978 as a result of a preliminary study showing tumors in test animals given the drug.^[27] The study combined methapyrilene and nitrite in high doses before giving them to rats who then developed liver tumors.^[28][29] In 1979, Health and Human Services (formerly Health, Education, and Welfare) Secretary Joseph A. Califano Jr. asked the FDA to remove such drugs, including Sominex, from the market.^[30] A statement from a Williams Co. spokesman in 1978 had indicated that Sominex had always contained methapyrilene.^[31]

By June 1979, J. B. Williams Co. was marketing Sominex with pyrilamine, a drug that had not been tested for possible carcinogenic effects and had last been deemed safe for humans in FDA testing completed in the 1940s.^[32] The FDA recommended banning the use of pyrilamine maleate, potassium bromide, sodium bromide, and scopolamine hydrobromide that same year unless they could be proven safe and effective; as a result, most sleep aid drug manufacturers changed their formulas to stop using it.^[33]

At some point before 1986, the Sominex formula had changed to diphenhydramine.^[26]

On January 17, 1989, the FDA approved the use of diphenhydramine hydrochloride and diphenhydramine citrate;^[34] by then, Sominex and Sominex 2 both used at least one of these two chemical compounds.^[33] The list of unapproved chemicals for use as a sleep aid included not only those recommended for banning in 1979, but several others including acetaminophen, aspirin, and passion flower extract.^[34]

Pharmaceutical manufacturer GlaxoSmithKline owned the Sominex brand in 2011, and announced their decision to divest it in April 2011.^[35] Prestige acquired Sominex, along with 16 other brand names, from GlaxoSmithKline in December 2011 for US$661.6 million.^[36]

In July 1975, the J. B. Williams Co. began marketing Sominex 2.^[37] On November 24, 1975, Attorney General Evelle J. Younger filed suit on behalf of the State of California against Williams Co., stating that the product did not warn against use by pregnant or nursing women or persons with asthma or COPD, nor did it notify consumers that it should not be used in conjunction with alcohol.^[38] The California Department of Health ordered Williams Co. to immediately cease sales of Sominex 2, which the company refused to do.^[38]

On December 2, 1975, the FDA ordered Sominex 2, which included diphenhydramine, to be removed from the market because the packaging was not child-resistant and the label did not include necessary warnings.^[22] They also stated that the use of diphenhydramine in an OTC drug was illegal.^[37] The FDA subsequently issued a recall for all outstanding Sominex 2 stock.^[39]

Television advertisements for Sominex 2 in 1983, manufactured by Beecham, made specific claims as to the effectiveness and physician preference for diphenhydramine.^[40]

In the UK, Actavis marketed promethazine hydrochloride under the Sominex name.^[41] It was available at least as early as 1985 as an OTC hypnotic.^[42]

Actavis also marketed a product by the name of Sominex Herbal, an herbal sleep aid with three natural active ingredients: hops, valerian, and passion flower extracts.^[43]

Competing with GSK in the UK, Actavis ran an ad in 2010 for Sominex—their first television promotional campaign for the drug—in an attempt to increase the market share for their formulation of Sominex.^[44]

In 2018, Actavis withdrew Sominex from the market, according to the HPRA.^[45] In 2024, the medicine is marketed by Teva UK Limited.^[8]

The promethazine formula of Sominex was included in a recall issued in 2010 in the United Arab Emirates by Ministry of Health and Prevention Ministerial Decree No. 366 before receiving approval.^[46]

As a first-generation antihistamine, diphenhydramine is considered to be a sedative. Clinic trials of this class of drug versus a placebo have shown that the medication can affect attention, motor control, and memory.^[47]

It has been described as causing euphoria, hallucinations and psychosis, as well as tachycardia, blurred vision, and hyperactivity, among numerous other effects. Chronic use has been shown to cause dependence with large dosages.^[48]

In 1969, Washington Hospital Center discovered four patients in their care who were suffering from scopolamine toxicity, their symptoms mimicking schizophrenia.^[49] In 1964, Sominex use resulted in severe reactions for six patients who suffered hallucinations and disorientation.^[49]

In 1972, Sominex included methapyrilene, a drug known to cause nausea, vomiting, hypotension and central nervous system depression, among other effects, when taken in excess.^[50]

The formula used in 1975 included scopolamine, a hallucinogen rather than a sedative, which an FDA panel found to be an ineffective sleep aid at the manufacturer-recommended dosage as well as potentially deadly, with higher dosages possibly causing delirium and violence, and possibly leading to paralysis, coma, or death.^[51] The 306-page report compiled by 7 experts was presented to the FDA on December 4, 1975.^[52] Regular scopolamine use was also linked to the development of glaucoma.^[51]

In 1976, physostigmine was recommended as a treatment for toxicity of drugs with anticholinergic properties, including Sominex.^[53]

In elderly people, the side effects have been shown to include dry or sticky lips, urinary issues, pale or dry skin, falling without cause, blurry vision, anxiety, tachycardia, or cardiac arrhythmia.^[54]

A case in Canada revealed that patients taking medication for chronic schizophrenia may experience tardive dyskinesia when taking Sominex in a manner other than prescribed.^[55]

When taking psilocybin, patients have reported increased blood pressure (but not hypertension).^[56]