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A New Sleeping Pill called Intermezzo

Posted on November 27, 2011 by Brian Yalung

It looks like there is a new sleeping pill made for people who get up in the middle of the night. The new sleeping pill is called Intermezzo, a new formula from Ambien that has just been approved by the FDA. However, there are certain dosage requirements for males and females.

The dose of Intermezzo is 1.75 mg for women and 3.5 mg for men. The reason for the different doses is due to the slower clearance rate in women. The standard dose of Ambien for sleep is 5-10 mg each night. The new sleeping

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Stimulation Therapy for Sleep Apnea Patients

Posted on August 4, 2011 by Brian Yalung

Here is a solution that should help out sleep apnea sufferers although I am not sure how many people would be more than willing to have something inserted in their bodies to address it. Apparently the apparatus is a pulse generator which is said to be something that would be inserted below the collar bone of people.

The pulse will eventually stop the tongue from blocking the airway during sleep. The device (placed just under the hypoglossal nerve) will synchronize with breathi

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P&G Backs Somaxon for Launch of New Sleep Drug

Posted on August 25, 2010 by Brian Yalung

Somaxon has gotten a big boost after Proctor & Gamble promised to help them sell Silenor to thousands of U.S. doctors and pharmacies. Both companies have agreed in principle to start the marketing efforts for the new sleep drug this September.

The deal also places Procter & Gamble first in line to negotiate for the rights to develop and market an over-the-counter version of Silenor in the United States. However, Somaxon would have to win FDA approval first before the drug could be sold w

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Astra-Zeneca Settles Drug Issue in Wisconsin

Posted on May 11, 2010 by Brian Yalung

Wisconsin got a multi-state settlement from drug maker Astra-Zeneca for marketing an anti-psychotic drug which did not gain FDA approval. The said drug was aimed towards treating sleep problems such as insomnia and other psychiatric conditions.

Astra-Zeneca denied these claims and chose to settle the issue rather than let the drug issue get out of hand. At $4 million, that was indeed some issue which cost them a lot of dough!

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Jet Lag Drug Stalled

Posted on April 2, 2010 by Brian Yalung

Nuvigil has been declined for approval by the U.S. Health regulators after some questionable data in making the said Cephalon sleep disorder drug. Nuvigil is a successor to Provigil and was introduced last June. Cephalon received a response letter of denial to approve the drug for jet lag this time.

According to the Centers for Disease Control and Prevention Agency in U.S, Jet Lag is a condition marked by a disrupted sleep cycle, headaches, or an upset stomach. Initially, The FDA had given an expe

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Non-Abusable FDA Treatment Cleared by FDA

Posted on March 19, 2010 by Brian Yalung

Somaxon Pharmaceuticals Inc. got approval for its insomnia drug Silenor after three tries from the FDA. The company had initially sent their drug application as early as January, 2008 which eventually got declined. Somaxon resubmitted its application on January 21, 2010, which was considered as Class 1 resubmission with a two-month review cycle resulting in a decision date by March 21, 2010.

Silenor has not been designated as a controlled substance by the U.S. Drug Enforcement Administratio

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Silenor Insomnia Drug Still Unapproved

Posted on December 13, 2009 by Brian Yalung

For the second time in a row the Silenor drug for Insomnia has been declined. Apparently the drug did not meet the approval standards for efficacy though no clinical issues were being placed in question. The FDA has requested the company to submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product.

Apparently this has been affecting the share value of the company which has dropped by more than 60%. The FDA declined to approve the drug back in February after citing concerns relating to heart health were t

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