Belsomra Approved for Imsomnia
August 13, 2014 – Belsomra (suvorexant) was approved by the Food and Drug Administration for use in the treatment of Insomnia, difficulties with sleep onset or sleep maintenance. Belsomra is manufactured by Merck.
The first medication in a new class of medications called orexin receptor antagonists, Belsomra works by blocking orexins, which are chemicals that help regulate sleep cycles and keep people awake. Belsomra will be available in 5mg, 10mg, 15mg, and 20mg strength tablets and is anticipated to be available on the market between the end of 2014 and the beginning of 2015.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.