Midodrine Hydrochloride and Sominex

• Generic Name: midodrine
• Dosage Forms: n.a.
• Other Brand Names: Proamatine, Orvaten

Treatment of symptomatic orthostatic hypotension (designated an orphan drug by FDA for this use). Indication is based on effect on increases in 1-minute standing systolic BP, a surrogate marker; clinical benefits (principally improved ability to perform life activities) not established. Continue the drug only in patients who report substantial symptomatic improvement.

Use recommended only in patients whose lives are considerably impaired despite standard clinical care; use only after nondrug therapies (e.g., support hose, increased sodium intake, life-style modifications) and fluid expansion have failed. May be more effective than comparative drugs (e.g., ephedrine) in managing postural symptoms.

In August 2010, FDA proposed to withdraw approval of midodrine because required postapproval studies verifying the clinical benefit of the drug had not been done. FDA stated that neither the original manufacturer (Shire) nor any generic manufacturer had demonstrated clinical benefit (e.g., performance of life activities); data submitted had not verified expected clinical benefit. In September 2010, FDA clarified that its proposal was part of the regulatory process and that midodrine could remain on the market as that process moves forward. Subsequently, FDA and Shire reached an agreement that Shire would conduct 2 additional clinical studies to verify the clinical benefit of midodrine in patients with symptomatic orthostatic hypotension. In February 2012, FDA announced that the proposal to withdraw approval of midodrine will be deferred until these studies have been conducted; meanwhile, the drug remains approved and available on the US market. In September 2014, FDA extended the deadline to March 31, 2015 for final submission of study results and analyses for FDA review.

• Generic Name: diphenhydramine
• Dosage Forms: n.a.
• Other Brand Names: Allergy Relief, Allermax, Banophen, Benadryl, Compoz Nighttime Sleep Aid, Diphedryl, Diphenhist, Dytuss, Nytol QuickCaps, PediaCare Children's Allergy, Q-Dryl, QlearQuil Nightitme Allergy Relief, Quenalin, Scot-Tussin Allergy Relief Formula, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleepinal, Sominex, Tranquil, Twilite, Unisom Sleepgels Maximum Strength, Valu-Dryl, Vanamine PD, Z-Sleep, ZzzQuil, plus many others, Benadryl Allergy, Complete Allergy, Nytol, Unisom SleepMelts

Sominex is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Sominex is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Sominex is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson's disease.

Sominex may also be used for purposes not listed in this medication guide.