With New Sleeping Pill, New Acceptability?

[Guest guest]

http://www.nytimes.com/2004/12/17/business/17sleep.html

--------------------------------------------------------------------------------

December 17, 2004

With New Sleeping Pill, New Acceptability?

By ANDREW POLLACK

Is it a wake-up call for the sleeping pill market? With Wednesday's approval

of Sepracor's new drug, Lunesta, a taboo in the use of sleeping pills has

been broken. Lunesta is the first sleeping pill whose label will not

recommend it be taken for only 7 to 10 days.

The approval could clear the way for people to use Lunesta, and possibly

similar drugs, for longer periods and turn sleeping pills from a market

laggard into a much more widely used category of medications, sleep

specialists said. " That's going to make a lot of people more comfortable

prescribing longer term, because the data exists, " said Dr. L.

Perlis, an associate professor and director of the sleep research laboratory

at the University of Rochester, who has consulted for Sepracor and other

drug companies.

But some specialists worry that the new approval, and a marketing push that

Sepracor is planning, will lead to the overuse of sleeping pills. Sepracor

has published data on only six months of continuous use, they said, and

longer-term effects are unknown.

Dr. Gregg D. s, an assistant professor of psychiatry at Harvard Medical

School and an insomnia specialist at Beth Israel Deaconess Medical Center in

Boston, said, " The rationale for marketing a sleeping pill for long-term use

is not only premature but also questionable and probably inappropriate. "

Dr. s conducted a study showing that talk therapy was more effective

and longer lasting than sleeping pills. He said that in clinical trials,

Lunesta still left people with " significant insomnia. " Most people with

insomnia do not need sleeping pills, Dr. s said, but added that

" there's a huge financial interest " for companies in promoting them.

Sepracor, a still unprofitable company based in Marlborough, Mass., plans to

say in its advertisements that Lunesta can be used " night after night after

night, " W. O'Shea, the president, told securities analysts in a

conference call yesterday.

He said 1,250 sales representatives would call on doctors and the company

would spend at least $60 million next year to advertise to consumers,

including on prime-time and cable television. " The level of effort, " he

said, " actually will be in the order of what you would see and enjoy from

Mc's in the first quarter. "

Sepracor said the wholesale price of Lunesta would be $3.70 a pill, about 10

percent more than Ambien, the leading drug. The company said it expected

that many insurance plans would at least partly cover Lunesta, which will be

available in January.

Some 58 percent of American adults experience at least one symptom of

insomnia a few nights a week, according to the results of a survey by the

National Sleep Foundation. Other studies have estimated that 10 to 15

percent of adults have severe or chronic insomnia.

Yet sales of sleeping pills are comparatively modest, a total of 35 million

prescriptions in the United States last year worth $1.75 billion, according

to IMS, a pharmaceutical information and consulting company. That made

sleeping pills the 29th most widely prescribed group of drugs, well below

antidepressants, the leader with 142 million prescriptions, and

cholesterol-lowering statins, with 126 million, according to IMS.

One reason is that insomnia is usually a far less serious condition than

depression or high cholesterol. Another has been a hesitancy to use the

drugs over a long term because of fears that they may become addictive, lose

their effectiveness after a while or cause daytime drowsiness.

Some sleep specialists say those concerns barely apply to newer sleeping

pills. And while cognitive behavioral therapy, the type advocated by Dr.

s in treating insomnia, can be effective, it is not always available,

they say - leaving a need for drugs, particularly those that can be used

safely for months.

" There's a fundamental disconnect there, " said Dr. J. Buysse, a

professor of psychiatry at the University of Pittsburgh who has been a

consultant to Sepracor and other drug companies. " We have a long-term

disorder with the only approved treatments being for the short term. "

Lunesta, specialists say, is not really that different from sleeping pills

like Ambien, the Sanofí-Aventis drug that dominates the market. Indeed,

Lunesta, known generically as eszopiclone, is a variation on an Aventis

drug, zopiclone, that has been available outside the United States for years

but never sold in this country.

But Sepracor did what other companies had not done: it showed in a clinical

trial that its drug remained safe and effective for at least six months.

The Food and Drug Administration did not relax other cautions, like the

possibility of the drug's being addictive. And the information for patients

that will be packaged with it advises them not to use the drug for long

periods without consulting a doctor.

Sepracor's stock jumped $4.85 yesterday, or 9.6 percent, to $55.30, as

analysts noted various features of the labeling that they said would help

give Lunesta a marketing advantage over Ambien. While Sepracor executives

said that Lunesta might eventually achieve $1 billion in annual sales, Ian

on, an analyst with SG Cowen, predicted that sales might not exceed

$600 million to $700 million because the market would become more crowded.

Two other new drugs are awaiting approval by the F.D.A., one developed by

Neurocrine Biosciences and Pfizer, the other by Takeda Pharmaceutical. Merck

has a drug in late-stage clinical trials that it licensed from H. Lundbeck

of Denmark. Sanofí, which will face generic competition for Ambien in 2006,

has applied for approval of a longer-acting version of that drug.

Copyright 2004 The New York Times Company | Home | Privacy Policy | Search |

Corrections | RSS | Help | Back to Top

[Guest guest]

http://www.nytimes.com/2004/12/17/business/17sleep.html

--------------------------------------------------------------------------------

December 17, 2004

With New Sleeping Pill, New Acceptability?

By ANDREW POLLACK

Is it a wake-up call for the sleeping pill market? With Wednesday's approval

of Sepracor's new drug, Lunesta, a taboo in the use of sleeping pills has

been broken. Lunesta is the first sleeping pill whose label will not

recommend it be taken for only 7 to 10 days.

The approval could clear the way for people to use Lunesta, and possibly

similar drugs, for longer periods and turn sleeping pills from a market

laggard into a much more widely used category of medications, sleep

specialists said. " That's going to make a lot of people more comfortable

prescribing longer term, because the data exists, " said Dr. L.

Perlis, an associate professor and director of the sleep research laboratory

at the University of Rochester, who has consulted for Sepracor and other

drug companies.

But some specialists worry that the new approval, and a marketing push that

Sepracor is planning, will lead to the overuse of sleeping pills. Sepracor

has published data on only six months of continuous use, they said, and

longer-term effects are unknown.

Dr. Gregg D. s, an assistant professor of psychiatry at Harvard Medical

School and an insomnia specialist at Beth Israel Deaconess Medical Center in

Boston, said, " The rationale for marketing a sleeping pill for long-term use

is not only premature but also questionable and probably inappropriate. "

Dr. s conducted a study showing that talk therapy was more effective

and longer lasting than sleeping pills. He said that in clinical trials,

Lunesta still left people with " significant insomnia. " Most people with

insomnia do not need sleeping pills, Dr. s said, but added that

" there's a huge financial interest " for companies in promoting them.

Sepracor, a still unprofitable company based in Marlborough, Mass., plans to

say in its advertisements that Lunesta can be used " night after night after

night, " W. O'Shea, the president, told securities analysts in a

conference call yesterday.

He said 1,250 sales representatives would call on doctors and the company

would spend at least $60 million next year to advertise to consumers,

including on prime-time and cable television. " The level of effort, " he

said, " actually will be in the order of what you would see and enjoy from

Mc's in the first quarter. "

Sepracor said the wholesale price of Lunesta would be $3.70 a pill, about 10

percent more than Ambien, the leading drug. The company said it expected

that many insurance plans would at least partly cover Lunesta, which will be

available in January.

Some 58 percent of American adults experience at least one symptom of

insomnia a few nights a week, according to the results of a survey by the

National Sleep Foundation. Other studies have estimated that 10 to 15

percent of adults have severe or chronic insomnia.

Yet sales of sleeping pills are comparatively modest, a total of 35 million

prescriptions in the United States last year worth $1.75 billion, according

to IMS, a pharmaceutical information and consulting company. That made

sleeping pills the 29th most widely prescribed group of drugs, well below

antidepressants, the leader with 142 million prescriptions, and

cholesterol-lowering statins, with 126 million, according to IMS.

One reason is that insomnia is usually a far less serious condition than

depression or high cholesterol. Another has been a hesitancy to use the

drugs over a long term because of fears that they may become addictive, lose

their effectiveness after a while or cause daytime drowsiness.

Some sleep specialists say those concerns barely apply to newer sleeping

pills. And while cognitive behavioral therapy, the type advocated by Dr.

s in treating insomnia, can be effective, it is not always available,

they say - leaving a need for drugs, particularly those that can be used

safely for months.

" There's a fundamental disconnect there, " said Dr. J. Buysse, a

professor of psychiatry at the University of Pittsburgh who has been a

consultant to Sepracor and other drug companies. " We have a long-term

disorder with the only approved treatments being for the short term. "

Lunesta, specialists say, is not really that different from sleeping pills

like Ambien, the Sanofí-Aventis drug that dominates the market. Indeed,

Lunesta, known generically as eszopiclone, is a variation on an Aventis

drug, zopiclone, that has been available outside the United States for years

but never sold in this country.

But Sepracor did what other companies had not done: it showed in a clinical

trial that its drug remained safe and effective for at least six months.

The Food and Drug Administration did not relax other cautions, like the

possibility of the drug's being addictive. And the information for patients

that will be packaged with it advises them not to use the drug for long

periods without consulting a doctor.

Sepracor's stock jumped $4.85 yesterday, or 9.6 percent, to $55.30, as

analysts noted various features of the labeling that they said would help

give Lunesta a marketing advantage over Ambien. While Sepracor executives

said that Lunesta might eventually achieve $1 billion in annual sales, Ian

on, an analyst with SG Cowen, predicted that sales might not exceed

$600 million to $700 million because the market would become more crowded.

Two other new drugs are awaiting approval by the F.D.A., one developed by

Neurocrine Biosciences and Pfizer, the other by Takeda Pharmaceutical. Merck

has a drug in late-stage clinical trials that it licensed from H. Lundbeck

of Denmark. Sanofí, which will face generic competition for Ambien in 2006,

has applied for approval of a longer-acting version of that drug.

Copyright 2004 The New York Times Company | Home | Privacy Policy | Search |

Corrections | RSS | Help | Back to Top

[Guest guest]

http://www.nytimes.com/2004/12/17/business/17sleep.html

--------------------------------------------------------------------------------

December 17, 2004

With New Sleeping Pill, New Acceptability?

By ANDREW POLLACK

Is it a wake-up call for the sleeping pill market? With Wednesday's approval

of Sepracor's new drug, Lunesta, a taboo in the use of sleeping pills has

been broken. Lunesta is the first sleeping pill whose label will not

recommend it be taken for only 7 to 10 days.

The approval could clear the way for people to use Lunesta, and possibly

similar drugs, for longer periods and turn sleeping pills from a market

laggard into a much more widely used category of medications, sleep

specialists said. " That's going to make a lot of people more comfortable

prescribing longer term, because the data exists, " said Dr. L.

Perlis, an associate professor and director of the sleep research laboratory

at the University of Rochester, who has consulted for Sepracor and other

drug companies.

But some specialists worry that the new approval, and a marketing push that

Sepracor is planning, will lead to the overuse of sleeping pills. Sepracor

has published data on only six months of continuous use, they said, and

longer-term effects are unknown.

Dr. Gregg D. s, an assistant professor of psychiatry at Harvard Medical

School and an insomnia specialist at Beth Israel Deaconess Medical Center in

Boston, said, " The rationale for marketing a sleeping pill for long-term use

is not only premature but also questionable and probably inappropriate. "

Dr. s conducted a study showing that talk therapy was more effective

and longer lasting than sleeping pills. He said that in clinical trials,

Lunesta still left people with " significant insomnia. " Most people with

insomnia do not need sleeping pills, Dr. s said, but added that

" there's a huge financial interest " for companies in promoting them.

Sepracor, a still unprofitable company based in Marlborough, Mass., plans to

say in its advertisements that Lunesta can be used " night after night after

night, " W. O'Shea, the president, told securities analysts in a

conference call yesterday.

He said 1,250 sales representatives would call on doctors and the company

would spend at least $60 million next year to advertise to consumers,

including on prime-time and cable television. " The level of effort, " he

said, " actually will be in the order of what you would see and enjoy from

Mc's in the first quarter. "

Sepracor said the wholesale price of Lunesta would be $3.70 a pill, about 10

percent more than Ambien, the leading drug. The company said it expected

that many insurance plans would at least partly cover Lunesta, which will be

available in January.

Some 58 percent of American adults experience at least one symptom of

insomnia a few nights a week, according to the results of a survey by the

National Sleep Foundation. Other studies have estimated that 10 to 15

percent of adults have severe or chronic insomnia.

Yet sales of sleeping pills are comparatively modest, a total of 35 million

prescriptions in the United States last year worth $1.75 billion, according

to IMS, a pharmaceutical information and consulting company. That made

sleeping pills the 29th most widely prescribed group of drugs, well below

antidepressants, the leader with 142 million prescriptions, and

cholesterol-lowering statins, with 126 million, according to IMS.

One reason is that insomnia is usually a far less serious condition than

depression or high cholesterol. Another has been a hesitancy to use the

drugs over a long term because of fears that they may become addictive, lose

their effectiveness after a while or cause daytime drowsiness.

Some sleep specialists say those concerns barely apply to newer sleeping

pills. And while cognitive behavioral therapy, the type advocated by Dr.

s in treating insomnia, can be effective, it is not always available,

they say - leaving a need for drugs, particularly those that can be used

safely for months.

" There's a fundamental disconnect there, " said Dr. J. Buysse, a

professor of psychiatry at the University of Pittsburgh who has been a

consultant to Sepracor and other drug companies. " We have a long-term

disorder with the only approved treatments being for the short term. "

Lunesta, specialists say, is not really that different from sleeping pills

like Ambien, the Sanofí-Aventis drug that dominates the market. Indeed,

Lunesta, known generically as eszopiclone, is a variation on an Aventis

drug, zopiclone, that has been available outside the United States for years

but never sold in this country.

But Sepracor did what other companies had not done: it showed in a clinical

trial that its drug remained safe and effective for at least six months.

The Food and Drug Administration did not relax other cautions, like the

possibility of the drug's being addictive. And the information for patients

that will be packaged with it advises them not to use the drug for long

periods without consulting a doctor.

Sepracor's stock jumped $4.85 yesterday, or 9.6 percent, to $55.30, as

analysts noted various features of the labeling that they said would help

give Lunesta a marketing advantage over Ambien. While Sepracor executives

said that Lunesta might eventually achieve $1 billion in annual sales, Ian

on, an analyst with SG Cowen, predicted that sales might not exceed

$600 million to $700 million because the market would become more crowded.

Two other new drugs are awaiting approval by the F.D.A., one developed by

Neurocrine Biosciences and Pfizer, the other by Takeda Pharmaceutical. Merck

has a drug in late-stage clinical trials that it licensed from H. Lundbeck

of Denmark. Sanofí, which will face generic competition for Ambien in 2006,

has applied for approval of a longer-acting version of that drug.

Copyright 2004 The New York Times Company | Home | Privacy Policy | Search |

Corrections | RSS | Help | Back to Top

[Guest guest]

http://www.nytimes.com/2004/12/17/business/17sleep.html

--------------------------------------------------------------------------------

December 17, 2004

With New Sleeping Pill, New Acceptability?

By ANDREW POLLACK

Is it a wake-up call for the sleeping pill market? With Wednesday's approval

of Sepracor's new drug, Lunesta, a taboo in the use of sleeping pills has

been broken. Lunesta is the first sleeping pill whose label will not

recommend it be taken for only 7 to 10 days.

The approval could clear the way for people to use Lunesta, and possibly

similar drugs, for longer periods and turn sleeping pills from a market

laggard into a much more widely used category of medications, sleep

specialists said. " That's going to make a lot of people more comfortable

prescribing longer term, because the data exists, " said Dr. L.

Perlis, an associate professor and director of the sleep research laboratory

at the University of Rochester, who has consulted for Sepracor and other

drug companies.

But some specialists worry that the new approval, and a marketing push that

Sepracor is planning, will lead to the overuse of sleeping pills. Sepracor

has published data on only six months of continuous use, they said, and

longer-term effects are unknown.

Dr. Gregg D. s, an assistant professor of psychiatry at Harvard Medical

School and an insomnia specialist at Beth Israel Deaconess Medical Center in

Boston, said, " The rationale for marketing a sleeping pill for long-term use

is not only premature but also questionable and probably inappropriate. "

Dr. s conducted a study showing that talk therapy was more effective

and longer lasting than sleeping pills. He said that in clinical trials,

Lunesta still left people with " significant insomnia. " Most people with

insomnia do not need sleeping pills, Dr. s said, but added that

" there's a huge financial interest " for companies in promoting them.

Sepracor, a still unprofitable company based in Marlborough, Mass., plans to

say in its advertisements that Lunesta can be used " night after night after

night, " W. O'Shea, the president, told securities analysts in a

conference call yesterday.

He said 1,250 sales representatives would call on doctors and the company

would spend at least $60 million next year to advertise to consumers,

including on prime-time and cable television. " The level of effort, " he

said, " actually will be in the order of what you would see and enjoy from

Mc's in the first quarter. "

Sepracor said the wholesale price of Lunesta would be $3.70 a pill, about 10

percent more than Ambien, the leading drug. The company said it expected

that many insurance plans would at least partly cover Lunesta, which will be

available in January.

Some 58 percent of American adults experience at least one symptom of

insomnia a few nights a week, according to the results of a survey by the

National Sleep Foundation. Other studies have estimated that 10 to 15

percent of adults have severe or chronic insomnia.

Yet sales of sleeping pills are comparatively modest, a total of 35 million

prescriptions in the United States last year worth $1.75 billion, according

to IMS, a pharmaceutical information and consulting company. That made

sleeping pills the 29th most widely prescribed group of drugs, well below

antidepressants, the leader with 142 million prescriptions, and

cholesterol-lowering statins, with 126 million, according to IMS.

One reason is that insomnia is usually a far less serious condition than

depression or high cholesterol. Another has been a hesitancy to use the

drugs over a long term because of fears that they may become addictive, lose

their effectiveness after a while or cause daytime drowsiness.

Some sleep specialists say those concerns barely apply to newer sleeping

pills. And while cognitive behavioral therapy, the type advocated by Dr.

s in treating insomnia, can be effective, it is not always available,

they say - leaving a need for drugs, particularly those that can be used

safely for months.

" There's a fundamental disconnect there, " said Dr. J. Buysse, a

professor of psychiatry at the University of Pittsburgh who has been a

consultant to Sepracor and other drug companies. " We have a long-term

disorder with the only approved treatments being for the short term. "

Lunesta, specialists say, is not really that different from sleeping pills

like Ambien, the Sanofí-Aventis drug that dominates the market. Indeed,

Lunesta, known generically as eszopiclone, is a variation on an Aventis

drug, zopiclone, that has been available outside the United States for years

but never sold in this country.

But Sepracor did what other companies had not done: it showed in a clinical

trial that its drug remained safe and effective for at least six months.

The Food and Drug Administration did not relax other cautions, like the

possibility of the drug's being addictive. And the information for patients

that will be packaged with it advises them not to use the drug for long

periods without consulting a doctor.

Sepracor's stock jumped $4.85 yesterday, or 9.6 percent, to $55.30, as

analysts noted various features of the labeling that they said would help

give Lunesta a marketing advantage over Ambien. While Sepracor executives

said that Lunesta might eventually achieve $1 billion in annual sales, Ian

on, an analyst with SG Cowen, predicted that sales might not exceed

$600 million to $700 million because the market would become more crowded.

Two other new drugs are awaiting approval by the F.D.A., one developed by

Neurocrine Biosciences and Pfizer, the other by Takeda Pharmaceutical. Merck

has a drug in late-stage clinical trials that it licensed from H. Lundbeck

of Denmark. Sanofí, which will face generic competition for Ambien in 2006,

has applied for approval of a longer-acting version of that drug.

Copyright 2004 The New York Times Company | Home | Privacy Policy | Search |

Corrections | RSS | Help | Back to Top