Drug to shake up insomnia market

Sepracor Inc. yesterday said it plans to begin selling its long-awaited Lunesta sleeping pill next week, setting the stage for a marketing war that will wake up the insomnia market.

Sepracor, of Marlborough, said the Drug Enforcement Agency on Monday will publish rules to let it begin selling its prescription drug Lunesta, and that more than 40,000 pharmacies have already placed orders.

Lunesta's launch will mark an important moment in the $3.5 billion sleeping pill market, now dominated by the drug Ambien made by Sanofi-Aventis Group and King Pharmaceuticals' Sonata.

The Food and Drug Administration will let Sepracor claim that Lunesta will keep consumers asleep longer than its two main competitors. Also, Lunesta's label won't caution against its long-term use, which could give doctors more confidence prescribing it. In all more than 50 million Americans suffer from insomnia.

Sepracor plans a $60 million marketing campaign to tout Lunesta's advantages, said chief financial officer David Southwell, though he said it's too soon to discuss specific ads yet.

Lunesta will treat problems that studies have shown are widespread among insomniacs. For instance, he said, 70 percent of patients complain they wake up too early in the morning, which should make Lunesta more attractive to them. ''Sleep maintenance is key," he said.

Yet Lunesta is no sure bet for Sepracor, whose stock fell $1.63 to close at $55.78 yesterday falling with other biotechnology stocks. In the United States alone Sanofi-Aventis sold $1.9 billion worth of Ambien last year according to IMS Health, a pharmaceutical information and consulting company. Sanofi-Aventis hopes to get regulatory approvals for a longer-lasting version of Ambien soon, which could reduce Lunesta sales.

Another competitor is King Pharmaceuticals Inc. of Tennessee, whose Sonata medication is chemically similar to Ambien but doesn't keep patients asleep as long. The other firms like to claim that is a disadvantage which explains why Sonata holds a smaller market share than Ambien.

King, however, just began a campaign that claims Sonata is actually best for busy patients who don't have time to sleep eight hours a night, yet turn in late.

''If you're still awake, it's not too late for Sonata" reads one ad. Richard Pascoe, King senior vice president, said: ''It's a little incongruent, in our view, to have a drug that makes you commit to a long sleep, with the lifestyle in our country where people don't necessary get that much sleep."

Traditional sleeping pills like Halcion worked by activating a chemical switch in the brain known as the benzodiazepine receptor.

Starting with Ambien in the early 1990s, a new class of drugs known as ''non-benzodiazepines" began to dominate. They work on the same receptor in a more specific manner, causing fewer side effects like hangovers. Another widely prescribed drug for insomnia is the generic antidepressant Trazodone. Pfizer and other firms are also working on treatments.

Some think Lunesta's approval may not be a direct threat to the other companies. Merrill, Lynch analyst Gregory B. Gilbert said one possibility is that Lunesta might capture more share from Trazodone and become a $1 billion product even without displacing Ambien as the market leader.

Ross Kerber can be reached at kerber@globe.com.