A Sleeping Pill for Longer Use Wins Approval

[Guest guest]

http://www.nytimes.com/2004/12/16/business/16sleep.html

December 16, 2004

A Sleeping Pill for Longer Use Wins Approval

By ANDREW POLLACK

The Food and Drug Administration has approved a new sleeping pill that some

specialists say could pave the way for longer-term use of such medications.

The drug, developed by Sepracor, a pharmaceutical company in Marlborough,

Mass., will be called Lunesta. It had been called Estorra during its

development, but the F.D.A. deemed that name too similar to that of another

drug. Spokesmen for the company and the F.D.A. confirmed the approval last

night.

The F.D.A. now recommends that sleeping pills be used for no longer than 7

to 10 days. That is because there are concerns that the pills can lose

effectiveness over time or become addictive.

But Sepracor had participants in a clinical trial take Lunesta for six

months and found that it did not lose its effectiveness and remained

generally safe.

Southwell, Sepracor's chief financial officer, said in an interview

yesterday, before the company had received its approval, that the drug's

label would not contain the usual language about restricting use to 7 to 10

days. If that were the case, doctors would be more willing to prescribe

Lunesta for longer periods, doctors said.

" The ability to use these drugs on a long-term basis is very important to

people in the field and doctors in the trenches, " said Dr. Roth,

director of the sleep disorders and research center at Henry Ford Hospital

in Detroit. Dr. Roth is a consultant to Sepracor and other companies

developing sleeping pills.

However, as of last night, the exact wording on the label had not been made

public, so it was unclear how far the F.D.A. would go in relaxing its

cautions.

The sleeping pill market is now dominated by Sanofi-Aventis's Ambien. It

accounted for 90 percent of sales in dollars and two-thirds of prescriptions

last year, according to IMS Health, a pharmaceutical information and

consulting company. There were 35 million prescriptions for sleeping pills

last year in the United States, with sales totaling $1.7 billion, it said.

But now the market could be shaken up, and not only by Lunesta. Two other

drugs, one by Neurocrine Biosciences and Pfizer and the other by Takeda

Pharmaceutical, have been submitted to the F.D.A. for approval, as has a

new, longer-acting version of Ambien.

[Guest guest]

http://www.nytimes.com/2004/12/16/business/16sleep.html

December 16, 2004

A Sleeping Pill for Longer Use Wins Approval

By ANDREW POLLACK

The Food and Drug Administration has approved a new sleeping pill that some

specialists say could pave the way for longer-term use of such medications.

The drug, developed by Sepracor, a pharmaceutical company in Marlborough,

Mass., will be called Lunesta. It had been called Estorra during its

development, but the F.D.A. deemed that name too similar to that of another

drug. Spokesmen for the company and the F.D.A. confirmed the approval last

night.

The F.D.A. now recommends that sleeping pills be used for no longer than 7

to 10 days. That is because there are concerns that the pills can lose

effectiveness over time or become addictive.

But Sepracor had participants in a clinical trial take Lunesta for six

months and found that it did not lose its effectiveness and remained

generally safe.

Southwell, Sepracor's chief financial officer, said in an interview

yesterday, before the company had received its approval, that the drug's

label would not contain the usual language about restricting use to 7 to 10

days. If that were the case, doctors would be more willing to prescribe

Lunesta for longer periods, doctors said.

" The ability to use these drugs on a long-term basis is very important to

people in the field and doctors in the trenches, " said Dr. Roth,

director of the sleep disorders and research center at Henry Ford Hospital

in Detroit. Dr. Roth is a consultant to Sepracor and other companies

developing sleeping pills.

However, as of last night, the exact wording on the label had not been made

public, so it was unclear how far the F.D.A. would go in relaxing its

cautions.

The sleeping pill market is now dominated by Sanofi-Aventis's Ambien. It

accounted for 90 percent of sales in dollars and two-thirds of prescriptions

last year, according to IMS Health, a pharmaceutical information and

consulting company. There were 35 million prescriptions for sleeping pills

last year in the United States, with sales totaling $1.7 billion, it said.

But now the market could be shaken up, and not only by Lunesta. Two other

drugs, one by Neurocrine Biosciences and Pfizer and the other by Takeda

Pharmaceutical, have been submitted to the F.D.A. for approval, as has a

new, longer-acting version of Ambien.

[Guest guest]

http://www.nytimes.com/2004/12/16/business/16sleep.html

December 16, 2004

A Sleeping Pill for Longer Use Wins Approval

By ANDREW POLLACK

The Food and Drug Administration has approved a new sleeping pill that some

specialists say could pave the way for longer-term use of such medications.

The drug, developed by Sepracor, a pharmaceutical company in Marlborough,

Mass., will be called Lunesta. It had been called Estorra during its

development, but the F.D.A. deemed that name too similar to that of another

drug. Spokesmen for the company and the F.D.A. confirmed the approval last

night.

The F.D.A. now recommends that sleeping pills be used for no longer than 7

to 10 days. That is because there are concerns that the pills can lose

effectiveness over time or become addictive.

But Sepracor had participants in a clinical trial take Lunesta for six

months and found that it did not lose its effectiveness and remained

generally safe.

Southwell, Sepracor's chief financial officer, said in an interview

yesterday, before the company had received its approval, that the drug's

label would not contain the usual language about restricting use to 7 to 10

days. If that were the case, doctors would be more willing to prescribe

Lunesta for longer periods, doctors said.

" The ability to use these drugs on a long-term basis is very important to

people in the field and doctors in the trenches, " said Dr. Roth,

director of the sleep disorders and research center at Henry Ford Hospital

in Detroit. Dr. Roth is a consultant to Sepracor and other companies

developing sleeping pills.

However, as of last night, the exact wording on the label had not been made

public, so it was unclear how far the F.D.A. would go in relaxing its

cautions.

The sleeping pill market is now dominated by Sanofi-Aventis's Ambien. It

accounted for 90 percent of sales in dollars and two-thirds of prescriptions

last year, according to IMS Health, a pharmaceutical information and

consulting company. There were 35 million prescriptions for sleeping pills

last year in the United States, with sales totaling $1.7 billion, it said.

But now the market could be shaken up, and not only by Lunesta. Two other

drugs, one by Neurocrine Biosciences and Pfizer and the other by Takeda

Pharmaceutical, have been submitted to the F.D.A. for approval, as has a

new, longer-acting version of Ambien.

[Guest guest]

http://www.nytimes.com/2004/12/16/business/16sleep.html

December 16, 2004

A Sleeping Pill for Longer Use Wins Approval

By ANDREW POLLACK

The Food and Drug Administration has approved a new sleeping pill that some

specialists say could pave the way for longer-term use of such medications.

The drug, developed by Sepracor, a pharmaceutical company in Marlborough,

Mass., will be called Lunesta. It had been called Estorra during its

development, but the F.D.A. deemed that name too similar to that of another

drug. Spokesmen for the company and the F.D.A. confirmed the approval last

night.

The F.D.A. now recommends that sleeping pills be used for no longer than 7

to 10 days. That is because there are concerns that the pills can lose

effectiveness over time or become addictive.

But Sepracor had participants in a clinical trial take Lunesta for six

months and found that it did not lose its effectiveness and remained

generally safe.

Southwell, Sepracor's chief financial officer, said in an interview

yesterday, before the company had received its approval, that the drug's

label would not contain the usual language about restricting use to 7 to 10

days. If that were the case, doctors would be more willing to prescribe

Lunesta for longer periods, doctors said.

" The ability to use these drugs on a long-term basis is very important to

people in the field and doctors in the trenches, " said Dr. Roth,

director of the sleep disorders and research center at Henry Ford Hospital

in Detroit. Dr. Roth is a consultant to Sepracor and other companies

developing sleeping pills.

However, as of last night, the exact wording on the label had not been made

public, so it was unclear how far the F.D.A. would go in relaxing its

cautions.

The sleeping pill market is now dominated by Sanofi-Aventis's Ambien. It

accounted for 90 percent of sales in dollars and two-thirds of prescriptions

last year, according to IMS Health, a pharmaceutical information and

consulting company. There were 35 million prescriptions for sleeping pills

last year in the United States, with sales totaling $1.7 billion, it said.

But now the market could be shaken up, and not only by Lunesta. Two other

drugs, one by Neurocrine Biosciences and Pfizer and the other by Takeda

Pharmaceutical, have been submitted to the F.D.A. for approval, as has a

new, longer-acting version of Ambien.