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Unisom (DOXYLAMINE)
Unisom (doxylamine) is a small molecule antihistamine that targets the histamine H1 receptor. Originally developed by Sanofi Aventis US, it is now owned by Chattem and has been FDA-approved since 1948 for various allergic and respiratory conditions. Unisom is available as a generic medication, with multiple manufacturers, and is off-patent. It is used to treat conditions such as allergic conjunctivitis, rhinitis, and common cold symptoms. Key safety considerations include potential drowsiness and interactions with other medications.
At a glance
| Generic name | DOXYLAMINE |
|---|---|
| Sponsor | Chattem |
| Drug class | Antihistamine |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1948 |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Common cold
- Dermatographic urticaria
- Influenza-like symptoms
- Itching of skin
- Nasal congestion
- Nasal discharge
- Seasonal allergic rhinitis
- Sneezing
- Urticaria
- Vasomotor rhinitis
Common side effects
Key clinical trials
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers (PHASE1,PHASE2)
- A Clinical Evidence Study Evaluating Quality of Life Parameters Following Treatment With Robitussin (PHASE4)
- Date Fruit Benefits to Treat Morning Sickness in First Trimester of Pregnancy (NA)
- Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers (PHASE1)
- Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy (NA)
- Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy (NA)
- The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents (PHASE3)
- Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Unisom CI brief — competitive landscape report
- Unisom updates RSS · CI watch RSS
- Chattem portfolio CI